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

FDA device recall Z-1634-2026 · posted 2026-03-24 · Open, Classified

Recall details

Recalling firm

AMO Puerto Rico Manufacturing, Inc.

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

HQL

Quantity affected

361

Distribution

U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.

Date initiated

2026-02-19

Date posted

2026-03-24

Location

Anasco, PR