AMO Puerto Rico Manufacturing, Inc.
Device Recalls (Class II)
Class II
Z-1634-2026
·
20260401
·
Ongoing
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 ...
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.
Source: openFDA Enforcement API