Z-2287-2020 Class II Terminated
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