Z-2287-2020 Class II Terminated
FDA device recall Z-2287-2020 was initiated by Alcon Research LLC on April 17, 2020 and is designated Class II. Reason for recall: Incorrect IOL diopter The recall status is terminated (terminated February 5, 2021). Affected quantity: 84 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- April 17, 2020
- Termination Date
- February 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 units
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
Distribution Pattern
US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
Code Information
Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1