PlainRecordsBrand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with…
- Reason
- Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
- Status
- Ongoing
- Distribution
- U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.
- Enforcement report date
- April 1, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- AMO Puerto Rico Manufacturing, Inc.
- Product
- Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No
- Reason
- Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
- Distribution pattern
- U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.
- Quantity
- 361
- Codes and lots
- Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403
- Recall started
- Feb. 19, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Intraocular Lens
- Root cause (FDA)
- Process control
- What the company told customers
- On 02/19/2026, the firm send via FedEx an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that in a limited quantity of TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity" Delivery System (DIB00) products exhibit an occurrence of haptics sticking to the optic, which can prevent the lens from unfolding as expected following lens insertion during the surgical procedure. Customers are instructed to: 1. Identify if any inventory contains TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity" Delivery System (DIB00). 2. Do not use and remove all affected TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity" Delivery System (DIB00) from inventory. 3. Complete Customer Reply Form. It is required information for reconciliation purposes with regulatory agencies, even if you have no inventory. For products to be returned: " Complete the Customer Reply Form, noting the serial number of the TECNIS Eyhance IOL (intraocular lens) with TECNIS Simplicity" Delivery System (DIB00). " Use the provided return label or contact the Global Post Market Safety Team at 1-877-266-4543, Option 2 to obtain an RGA number and arrange product return. " Email Customer Reply Form to JJV-US-ProductExperience@its.jnj.com within 3 business days of receipt of this letter. " If issues were encountered, inform JJSV by calling the Global Post Market Safety Team 1-877-266-4543, Option 2 or send an email to JJV-US-ProductExperience@its.jnj.com . If reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome. " Return affected product as soon as possible. The firm will work directly with customers to replace the affected unit and provide any necessary next steps. If you do not have product to be returned: " Review your patient records to confirm implantation of the impacted lens. No further action is required after the Customer Reply Form has been returned.
- Recall number
- Z-1634-2026
What this record is about
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“Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.”Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No, FDA enforcement report, 2026-04-01. The caption is the record's own words.
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FDA device name: Intraocular Lens
Distributed in (FDA's record): California Florida Illinois Maine Mississippi New Jersey New York Oklahoma Oregon Texas Wisconsin and nationwide
This recall among the others
- FDA's enforcement report came 41 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1634-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1634-2026, April 1, 2026. "Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with." PlainRecords, https://plainrecords.com/recall/device/z-1634-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections