FDA recall Z-2287-2020

Product

Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

Reason for recall

Incorrect IOL diopter

Distribution

US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.

Key facts

Status

Terminated

Initiation date

2020-04-17

Report date

2020-06-17

Termination date

2021-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2020