Device 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.
Z-2287-2020
Product summary
- Event
- Event 85563
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-2287-2020
Official wording
Reason: Incorrect IOL diopter
Code information: Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1
Distribution pattern: US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
Derived failure modes
-
Unknown
Incorrect IOL diopter