Reported Jun 3, 2015 · Terminated
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05…
Optimedica Corporation
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: Optimedica Corporation · 1310 Moffett Park Dr · Sunnyvale, CA · 94089-1133
Is this the product you have?
- Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
- Lot codes and dates
- Software version 3.00.05:
- Serial numbers - US
66 of 66 codes
440664134406311344065413440662134410271444060012440648134406101244061812441016144406831444056612440637134410261444068914440735144407481444061612440737144405631244061412440666134406941444069814440709144407271444073014440731144407451444074614441007144406801444060612440628134406691444056012440622134406451344101014441008144406031244060412440635134405671244063313440639134407331444065613440583124406501344072114440724144407191444062613440652134405991244057312440597124405821244072814
- Serial numbers - OUS
70 of 70 codes
440552114405541144055711440561124405621244056412440565124405691244057112440572124405741244057512440577124405791244058512440586124405891244059012440591124405941244059512440612124406131244061512440617124406191344062113440623134406321344064013440642134406551344066313440668134406721444067414440675144406771444068114440684144406861444069214440695144406991444070014440701144407061444070714440710144407121444071314440714144407151444071714440718144407221444072314440726144407341444074014
- Amount recalled
- 171 distributed Worldwide
Where it was sold
- Nationwide
Why it was recalled
Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
This product could cause temporary or reversible health problems — stop using it.
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