FDA-Device2020-06-17Class II
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.
Alcon Research LLC
Hazard
Incorrect IOL diopter
Sold states
US Nationwide distribution including in the states of TX, PA, CT, IA, MI, NE.
Affected count
84 units
Manufactured in
Aspex Facility, 6201 South Fwy, Fort Worth, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2020Don't want to check this manually?
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