Reported Apr 29, 2015 · Terminated
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage:…
Abbott Medical Optics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Abbott Medical Optics, Inc. · 510 Cottonwood Dr · Milpitas, CA · 95035-7403
Is this the product you have?
- OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US)
- Product UsageIndicated for use in patients undergoing cataract surgery for removal of crystalline lens
- Lot codes and dates
- Device Serial No. (U.S.)Device Serial No. (Outside U.S.)
94 of 94 codes
440553114405561144055811440560124405631244056612440567124405681244057312440578124405801244058212440583124405921244059312440596124405971244059812440599124406001244060112440603124406041244060612440607124406091244061012440614124406161244061812440620134406221344062413440626134406281344063113440633134406341344063513440636134406371344063813440639134406411344064313440644134406451344064613440647134406481344065013440651134406521344065313440654134406561344066213440664134406661344066914
108 of 108 codes
440552114405541144055711440559114405611244056212440564124405651244056912440571124405721244057412440575124405761244057712440579124405811244058512440586124405891244059012440591124405941244059512440602124406051244061112440612124406131244061512440617124406191344062113440623134406291344063013440632134406401344064213440655134406571344065813440659134406631344066513440667134406681344067114440672144406741444067514440676144406771444067914440681144406821444068414440685144406861444069014
- Device Serial No. (U.S.)
- Amount recalled
- 202
Where it was sold
- Nationwide
Why it was recalled
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
This product could cause temporary or reversible health problems — stop using it.
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