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 Numbe

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.

Details from the source

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. Distribution: U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI. Quantity: 361 Lot/code info: Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403

UPC codes

05050474731776

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.