Image Description (Encelto Corepack Label)
Encelto Implant
Product Images NDC 82958-501
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 69 technical images submitted to the FDA as part of the official labeling for Encelto (NDC 82958-501). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Neurotech Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Figures 1 And 2 (Encelto Figure 1)
Image Description (Encelto Figure 16)
This text provides information about the components included in the Corepack, which consists of an outer container holding a sterile inner container, a disposable temperature recording device, and the ENCELTO Medium pH Color Guide. It also mentions items such as ENCELTO Instructions for Use, ENCELTO Inspection Checklist, and the United States Prescribing Information.*
Image Description (Encelto Figure 17)
This is a simple scale representation showing a 6.5 mm distance with a smaller 1.3 mm distance. It specifies that the image is not to scale, meaning the relative sizes of the objects in the image may not be accurate.*
Image Description (Encelto Figure 18)
This is a product description for a Luer lock cap with a gripper, fixation loop, and liquid medium. This product seems to be related to medical or laboratory equipment.*
Image Description (Encelto Figure 19)
Figures 3 And 4 (Encelto Figure 2)
Figures 5 And 6 (Encelto Figure 3)
Figures 7-9 (Encelto Figure 4)
Figure 10 (Encelto Figure 5)
Figure 11 (Encelto Figure 6)
Figure 12 (Encelto Figure 7)
Figures 13 And 14 (Encelto Figure 8)
Figure 15 (Encelto Figure 9)
Image Description (Encelto Ifu 1)
Image Description (Encelto Ifu 10)
ENCELTO is a product packaged in a protective inner container within an Endothelial Serum Free Media, designed for intraocular insertion. It does not contain preservatives and is handled using a gripper tool. The gripper tool suspends ENCELTO in the liquid medium within the packaging and assists in manipulation during preparation and insertion. Additionally, it includes a fixation loop for suturing to the sclera. ENCELTO comes in a semi-permeable capsule with specific dimensions and a liquid medium to sustain it during storage and transport.*
Image Description (Encelto Ifu 11)
This text provides instructions for the storage, handling, and disposal of ENCELTO implants. It advises on proper temperature conditions, checks for acceptable pH levels, and outlines steps in case of exposure to undesirable conditions. Additionally, it includes a contact number for further assistance regarding assessment, refund, or replacement of the implant.*
Image Description (Encelto Ifu 12)
This text provides detailed warnings and instructions for using ENCELTO, a neuroteen product. It includes information about preparatory procedures, insertion procedures, surgical site preparation, and ENCELTO preparation. Specific instructions are given on what to do if there is damage or signs of compromised sterility. Adherence to these instructions is crucial for safe and effective use of ENCELTO.*
Image Description (Encelto Ifu 13)
This text provides crucial instructions on the proper insertion and closure techniques for the ENCELTO device during eye surgery. It emphasizes the importance of secure suturing with polypropylene anchors to prevent migration and extrusion of the device. Recommendations include ensuring tight locking throws, correct depth placement, and avoiding off-center suturing to minimize risks of complications. Additionally, guidelines on knot tying, needle handling, and postoperative care are outlined for successful wound closure and overall surgical outcomes.*
Image Description (Encelto Ifu 14)
This text provides important information about postoperative wound care for the removal of ENCELTO, emphasizing the risks associated with failure to follow antibiotic and steroid application instructions. It also outlines specific procedures for ENCELTO removal and closure, highlighting the importance of not cutting polypropylene anchor sutures and the necessity of grasping the fixation loop to prevent complications. Following these guidelines is crucial to avoid injury, inflammation, or infection during post-operative care.*
Image Description (Encelto Ifu 15)
This text provides information about precautions, contraindications, and the use of ENCELTO in ophthalmic procedures. It emphasizes the lack of data on ENCELTO's use in pregnant women and the effects on breastfed infants and milk production. ENCELTO is contraindicated in patients with ocular infections or hypersensitivity to Endothelial Serum Free Media. It mentions compatibility with various standard procedures such as ultrasound, ophthalmoscopy, tonometry, and imaging techniques like OCT and fluorescein angiography. It also advises caution during ophthalmic procedures to avoid deflection of ENCELTO and potential injury.*
Image Description (Encelto Ifu 16)
This text provides safety guidelines for Magnetic Resonance Imaging (MRI) of a patient with ENCELTO. It outlines the conditions under which the patient can be scanned and emphasizes the importance of adhering to these conditions to prevent harm. Specific details such as magnetic field strength, spatial gradient, coil types, and operating parameters are included to ensure a safe and effective MRI procedure for the patient.*
Image Description (Encelto Ifu 17)
Image Description (Encelto Ifu 18)
Image Description (Encelto Ifu 19)
The text provides instructions for the ENCELTO insertion procedure, including preparatory steps and inspection guidelines before use. It emphasizes the importance of checking the corepack for damage or leakage, ensuring the expiration date has not passed, and verifying the disposable temperature recording device. Additionally, it outlines cautionary steps to take in case of temperature exposure issues and provides contacts for immediate assistance. These guidelines aim to maintain the integrity and effectiveness of ENCELTO during surgical procedures.*
Image Description (Encelto Ifu 2)
Image Description (Encelto Ifu 20)
Neuroteen provides instructions for inspecting and using ENCELTO, a liquid medium. It advises to check for intact seals and films, ensure the medium is in the correct position, and contact Neurotech if there are any signs of damage. The ENCELTO Medium pH Color Guide helps users confirm the liquid's pH level. Warning against use if pH is outside the acceptable range. Contact Neurotech for assistance or further instructions.*
Image Description (Encelto Ifu 21)
The provided text contains instructions for the ENCELTO insertion procedure. It outlines steps for transferring the inner container to a sterile field, handling the outer container, and ensuring the sterility of the inner container. Additionally, it provides guidance on inspecting the ENCELTO for signs of compromise or contamination. Contact information for Neurotech is also included in case of concerns.*
Image Description (Encelto Ifu 22)
This text provides instructions for surgical site preparation for the insertion of an ENCELTO device. It includes steps like identifying the insertion site, conducting conjunctival peritomy, creating incisions, dissecting conjunctiva and Tenon's capsule, and maintaining hemostasis. The text also emphasizes avoiding creating buttonholes and blood entering the scleral wound during the procedure.*
Image Description (Encelto Ifu 23)
The text appears to be related to a medical procedure for placing a corneal-limbal traction suture using a specific size and type of suture on a spatulated needle. The use of a suture is emphasized in the inferotemporal or inferonasal quadrant. Care is advised to prevent complications such as penetrating the anterior chamber which can lead to visual impairment. This procedure involves microscopic visualization as per the available documentation for proper guidance.*
Image Description (Encelto Ifu 24)
The provided text appears to be a set of instructions for performing a 3.0 mm sclerotomy in a medical procedure, involving measuring and marking specific distances from the limbus, creating a scleral incision, and enlarging it. The instructions emphasize the importance of maintaining precise measurements, using appropriate tools like a 20-gauge microvitreoretinal blade, and ensuring that the incision is full-thickness with square corners. The text also contains warnings to avoid inserting ENCELTO outside of the pars and stresses the need for accuracy throughout the procedure.*
Image Description (Encelto Ifu 25)
This text provides guidance on the technique of gently opening the sclerocorneal incision during eye surgery, ensuring it is full-thickness and that hemostasis is achieved. It emphasizes the importance of precision to prevent potential complications like vitreous hemorrhage, cyclodialysis, or retinal detachment. Additionally, it advises on steps to take in case of any active bleeding or uveal tissue involvement. The text also mentions the need to excise significant prolapsed vitreous using techniques like 'Weck-Cel vitrectomy' or a standard vitrectomy cutter before insertion.*
Image Description (Encelto Ifu 26)
This text provides step-by-step instructions for preparing the ENCELTO neurotech device for insertion. It emphasizes the importance of ensuring the product's integrity and sterility before use. The procedure involves peeling back the lid film, unlocking the luer lock cap, and removing the ENCELTO device attached to the gripper from the inner container. It also cautions against dislodging the device and advises avoiding contact with any surface. For assistance or in case of damaged product, contact Neurotech at 1-833-963-9275.*
Image Description (Encelto Ifu 27)
This text provides instructions on how to properly rinse and maintain the ENCELTO device using Balanced Salt Solution (BSS). It emphasizes the importance of rinsing with at least 5 mL of BSS before insertion and regularly applying BSS every 10 minutes to keep the device moist and prevent dehydration. The text also warns against exposing ENCELTO to air for more than 10 minutes and advises using only BSS or other salt solutions for rinsing. Additionally, it cautions against touching the device and resting it on an absorbent surface to avoid compromising the therapy efficacy.*
Image Description (Encelto Ifu 28)
This text provides instructions on how to prepare ENCELTO for insertion, specifically guiding the user on passing a suture needle through the fixation loop at the end of ENCELTO under a microscope. It emphasizes pulling one fourth of the suture length to make knot creation easier than pulling halfway. The caution mentioned warns against using alternative sutures to avoid post-operative complications.*
Image Description (Encelto Ifu 29)
This is a set of guidelines for the insertion and closure of a medical device called ENCELTO. It contains warnings about using damaged or compromised devices, along with instructions for the proper insertion technique including confirming hemostasis and avoiding insertion towards the lens or deeply into the eye. It provides a caution against inserting the device beyond the fixation loop. The text advises on opening the sclerotomy incision and inserting ENCELTO perpendicularly through the scleral incision. There are also references to visual aids such as Figures 25 and 26 for better understanding the insertion process.*
Image Description (Encelto Ifu 3)
This text describes an ENCELTO Patient Card given to patients after a procedure. The card contains important information related to ENCELTO, such as the patient's name, physician's name, clinic name and phone number, date of insertion, LOT number, and neurotec. Patients are advised to keep the card in a safe place for future reference and to show it to their current and future eye care providers for consultation.*
Image Description (Encelto Ifu 30)
This text provides instructions on how to release and handle an ENCELTO insertion tool. It includes guidance on using forceps, squeezing the gripper in the indicated region, and avoiding damage to the device. It also mentions the importance of contacting Neurotech in case of any issues or damages to initiate the return of ENCELTO for possible replacement.*
Image Description (Encelto Ifu 31)
The text seems to be a set of instructions for a medical procedure involving sutures. It explains the process of creating an anchor knot using a polypropylene suture and gives cautions about handling the suture carefully to prevent migration and extrusion. It also emphasizes the importance of placing the anchor knot correctly in the fixation loop. Overall, it highlights specific steps and precautions for successful execution of the procedure.*
Image Description (Encelto Ifu 32)
This text provides detailed instructions on how to anchor ENCELTO to the sclera during a medical procedure. It includes information on handling the sclerotomy, passing the polypropylene suture through the wound, adjusting the fixation loop, and avoiding common pitfalls such as shallow placement of sutures and off-center positioning. The text emphasizes the importance of correct wound closure and proper suture placement to minimize the risks of migration and extrusion of the ENCELTO device.*
Image Description (Encelto Ifu 33)
This is a detailed guide on the correct procedure for using polypropylene sutures for ocular surgeries. It includes instructions on knot tying, suturing techniques, and warnings about potential complications. The text emphasizes the importance of proper handling of the sutures and needles to ensure a watertight closure of the sclera without causing migration or extrusion of the suture material. Adhering to the specified 3-1-1 knot tying technique is highlighted for effective wound closure and minimizing the risk of postoperative complications.*
Image Description (Encelto Ifu 34)
This text provides instructions on how to anchor ENCELTO to the sclera using a polypropylene suture. It mentions taking a 2.0 mm long bite of the sclera at a certain depth beyond the end of the sclerotomy on each side. There is also a warning not to pass the suture too far anterior or posterior to avoid other eye structures and a caution about not burying the suture ends to reduce the risk of post-operative complications. Additionally, Figure 33 illustrates creating 20 mm of sclera beyond the sclerotomy.*
Image Description (Encelto Ifu 35)
This text provides instructions for wound closure procedures using 9-0 nylon sutures for scleral incisions. It details the technique for closing the incision, capturing the polypropylene suture, and ensuring a watertight closure without gaps. The text also mentions the importance of square and tight knots and rotating the suture tails into the sclera for effective closure.*
Image Description (Encelto Ifu 36)
This text provides detailed instructions on wound closure in a surgical procedure involving suturing the sclera and conjunctiva. The text emphasizes the importance of pulling the suture taut and cutting it flush to the sclera to reduce the risk of post-operative complications such as suture exposure and irritation. It also mentions the materials recommended for suturing and the technique for conjunctival and Tenon's capsule closure. The use of buried sutures is suggested for optimal results. Overall, this text offers valuable guidance for achieving successful wound closure in a surgical setting.*
Image Description (Encelto Ifu 37)
This text provides a detailed description of a procedure involving administering a sub-conjunctival steroid injection, performing indirect ophthalmoscopy to confirm placement, and applying topical antibiotic to the eye. It also mentions the optional but beneficial practice of patching the eye to prevent conjunctival wound dehiscence. Following these steps carefully is essential to ensure successful outcomes and avoid complications.*
Image Description (Encelto Ifu 38)
Providing aftercare instructions for ENCELTO procedure including postoperative wound care such as antibiotic and steroid application. Patient should be given completed ENCELTO Patient Card to keep for future reference. Disposal of all materials should be done according to local institutional protocols. Warning about the importance of following postoperative antibiotic and steroid application to prevent risks. Instructions for antibiotic and steroid use after surgery are detailed. For information on complications, refer to the Adverse Reactions section of USPL.*
Image Description (Encelto Ifu 39)
This is a description for an intravitreal implant device called ENCELTO™. It provides information on the removal procedure for the product.*
Image Description (Encelto Ifu 4)
The text describes a medical implant called ENCELTO, which is MR Conditional and safe for use during magnetic resonance imaging (MRI) under specific conditions. It cautions that scanning under different conditions may lead to severe patient injury or implant malfunction. To obtain full MRI safety information, one can refer to the 'Magnetic Resonance Imaging (MRI)' section of the ENCELTO Instructions for Use available at www.ENCELTO.com/ecp/instructions-for-use or by calling 1-833-963-9275.*
Image Description (Encelto Ifu 40)
This text provides instructions for the preoperative procedure required before a neuroteen surgery. It includes a list of standard ophthalmic instruments needed for the procedure and suggests additional instruments like a 20 gauge microvireoreinal needle and a 15-degree ammerc blade for use. The text also mentions the use of sutures, topical antibiotics, and topical steroids. It advises on preparing the patient for surgery using sterile methods and standard operating room practices, including periocular preparation and draping. The procedure is recommended to be performed under local anesthesia using specific techniques like peribuloar, retrobulbar, or sub-tenon's.*
Image Description (Encelto Ifu 41)
This document provides detailed instructions for the removal of ENCELTO, a medical procedure that involves creating incisions and sutures in the eye area. It includes steps for conducting surgical site preparation, exposing the insertion site, dissecting the conjunctiva and Tenon's capsule, and using cautery for hemostasis. The text highlights the importance of avoiding complications such as penetrating the anterior chamber and preventing blood from entering the scleral wound. Visual impairment is also mentioned as a potential risk if proper care is not taken during the procedure.*
Image Description (Encelto Ifu 42)
The provided text outlines instructions for conducting a 3-port small gauge vitrectomy, focusing on placing an infusion cannula, visually confirming its positioning, and performing the vitrectomy to remove the vitreous surrounding the intended area without disrupting its integrity. The guide emphasizes the importance of handling the equipment carefully near the target area.*
Image Description (Encelto Ifu 43)
This text provides a detailed guide on the removal procedure for the ENCELTO implant, including locating and opening the incision, removing nylon sutures, and dissecting the original scleral incision. It emphasizes avoiding cautery on certain areas and provides warnings to prevent damage to the implant during the removal process. Specific instructions on the tools needed, such as a 20-gauge microvitreoretinal blade, are also included for performing the removal and closure effectively.*
Image Description (Encelto Ifu 44)
This text provides instructions for a medical procedure involving the incision and removal of a polypropylene anchor suture used in eye surgery. It emphasizes steps to ensure the proper handling of the suture to prevent displacement. Details include cutting the suture on the anterior side of the knot, avoiding cutting the posterior side before grasping the fixation loop, and confirming the absence of uveal tissue. Visual references to figures 48 and 49 are mentioned for guidance.*
Image Description (Encelto Ifu 45)
This text provides instructions for the removal of ENCELTO, a medical device. It mentions the use of toothed forceps to grasp the fixation loop and carefully remove ENCELTO from the eye to avoid damage. It emphasizes the importance of complete removal to prevent complications. Inspecting the ENCELTO capsule for damage or penetration is recommended. If there is suspicion of penetration, a complete vitrectomy may be necessary. Additionally, it provides a contact number for assessment before disposal or replacement of the ENCELTO implant according to institutional protocols.*
Image Description (Encelto Ifu 46)
This text provides a surgical procedure guideline for wound closure after removing prolapsed vitreous using an avitrector. It includes instructions for suturing the sclerotomy with interrupted Vicryl sutures, closing the conjunctiva with plan gut sutures, and administering a subconjunctival antibiotic injection. Figures 52, 53, and 54 demonstrate the step-by-step process for proper wound closure.*
Image Description (Encelto Ifu 47)
This is a set of instructions for the removal procedure of ENCELTO, a postoperative wound care regimen that includes the application of antibiotics and steroids. The importance of following the prescribed antibiotic and steroid schedule is emphasized to prevent potential complications such as injury, inflammation, or infection. The recommended postoperative treatment includes applying a topical antibiotic solution four times a day for seven days and a taper of prednisolone acetate 1% eye drops starting the day after surgery, following a specific dosage schedule for 28 days.*
Image Description (Encelto Ifu 48)
Image Description (Encelto Ifu 49)
Image Description (Encelto Ifu 5)
This is the table of contents for a document related to patient care instructions and procedures for using a medical device called ENCELTO. It includes information on preoperative procedures, surgical site preparation, postoperative wound care, ENCELTO insertion and closure, removal procedures, and precautions. The document also mentions components of the ENCELTO device, color guides, magnetic resonance imaging (MR) compatibility, and an overview of ENCELTO.*
Image Description (Encelto Ifu 50)
Image Description (Encelto Ifu 51)
Image Description (Encelto Ifu 52)
Neurotech Pharmaceuticals, Inc. is located at 900 Highland Corporate Drive in Cumberland, 02664. They hold License No. 2321. The document indicates that it is approved by the U.S. Food and Drug Administration, with the approval date being 2025106. All rights reserved.*
Image Description (Encelto Ifu 6)
This text refers to the instructions and description of a product called ENCELTO™, which is indicated for the treatment of adults with idiopathic macular telangiectasia type 2. The recommended dose is one implant per affected eye, containing allogeneic retinal pigment epithelial cells expressing ThCNTF. The product is described as a single-dose, sterile, nonpyrogenic and retrievable allogeneic encapsulated cell-based gene therapy product for surgical intravitreal placement. ENCELTO comes in a protective inner container with a liquid medium termed Endothelial Serum Free Media (Endo-SFM). The product's physical dimensions and components such as scaffold, titanium fixation loops, and medical grade materials are also specified in the description.*
Image Description (Encelto Ifu 7)
The text provides instructions for inspecting and preparing the Endo-SFM product contained within inner and outer packaging. It mentions conducting an inspection using a checklist before the product can be cleared for surgical use. The corepack contains components such as ENCELTO, instruction manuals, inspection checklist, and temperature recording device. Additionally, the outer container is held in support foam to maintain sterility during transfer to the surgical technician or surgeon.*
Image Description (Encelto Ifu 8)
Image Description (Encelto Ifu 9)
A detailed description of the Covepack components for medical use is provided here. The set includes a sterile container made of plastic with two compartments - one filled with liquid and the other for storage. An outer plastic container maintains the inner container's sterility until use. Additionally, there is a disposable temperature recording device included in the pack that measures and records the temperature within the container. The device displays the temperature readings and alerts if the temperature goes out of the acceptable range. There is also a color guide card provided to show the acceptable range for the liquid medium. The pack includes instructions and a patent disclaimer for proper use. Lastly, there is an inspection checklist for reference.*
Image Description (Encelto Product Label)
This is a description of a medical implant called ENCELTO™ for intravitreal use. The implant contains allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (MCNTF). The text provides information about the dosage and administration of the implant. It also mentions handling instructions with a focus on using sterile techniques. Additionally, it indicates a specific license number and address related to the pharmaceutical company.*
Image Description (Mr Conditional 2)
Mr Conditional Info (Mr Conditional)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
