Recall Z-1634-2026 ยท HQL Intraocular Lens
AMO Puerto Rico Manufacturing, Inc.
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
| Date | Mar 24, 2026 (initiated Feb 19, 2026) |
| Status | Open, Classified |
| 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. |
| 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 |
| Quantity | 361 |
| Distribution | U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.