Z-1634-2026Class II

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with...

Name: Z-1634-2026 Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with...
Creator: AMO Puerto Rico Manufacturing, Inc.
Published: 2026-02-19
License: https://open.fda.gov/license/

AMO Puerto Rico Manufacturing, Inc. / initiated 2026-02-19 / Open, Classified / root cause: manufacturing process

FDA source

AMO Puerto Rico Manufacturing, Inc. began a recall of Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog... on 2026-02-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1634-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-19
Posted: 2026-03-24
Recalling firm: 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
Product code: HQL Intraocular Lens
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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 [email protected] . 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.
Quantity in commerce: 361
Distribution: U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.
Product 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1634-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1634-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-24

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)