medical Class II Updated 2020-06-17

Alcon Research LLC recalls Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL,

Recalled 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.

Hazard / Issue

Incorrect IOL diopter

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number 12726594; Model Number: AU00T0V205; UDI # 038065GMN000065H7; 0380652394772(17)220630(21)12726594000(30)1
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