Reported Dec 2, 2015 · Terminated
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric…
Alcon Research, Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
- Lot codes and dates
721 of 721 codes
121565261215652712156528121565291215653012156531121581621215816312158164121581651215816612161289121612901216129112161292121612931216129412161295121612961216129712161298121612991216517312165174121651751216517612165179121651871216518812165192121651931219936212199363121993651219936712205570122058811220588212205883122058841220588512205886122058871220588812205889122058901220589112208850122088511220885212208853122088541220885512208856122088571220885812208859122088601220886112208862
- Amount recalled
- 43,651 units
Why it was recalled
Stop using this product now
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Using this product could cause serious injury, illness or death — stop using it now.
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