United StatesThe TECNIS Eyhance IOL with TECNIS Simplicity Delivery System (Model DIB00, SKU DIB00U0210-12, GTIN 05050474731776; affected serial numbers include 2409342403, 2410072403, 2409612403, 2409692403 and others) distributed nationwide in CA, FL, IL, ME, MS, NJ, NY, OK, OR, TX and WI is being recalled. The firm identified a limited quantity of intraocular lenses in which a haptic may stick to the optic and prevent the lens from unfolding consistently as expected.
What's being recalled
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…
Recalling firm: AMO Puerto Rico Manufacturing, Inc., Anasco, PR, United States.
How to identify it
Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)