Recall Z-2287-2020— Alcon Research LLC
Class II · Terminated
Class II FDA medical device recall by Alcon Research LLC, initiated 2020-04-17, terminated 2021-02-05. FDA's recall record names no specific 510(k) clearance for this event. 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: Incorrect IOL diopter.
- Recalling firm
- Alcon Research LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-17
- Terminated
- 2021-02-05
- Firm location
- Fort Worth, TX, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.