Reported Jan 15, 2014 · Terminated
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I…
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 (United States) - Catalys-UCatalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A
- Resettable CBTested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 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
All units shipped prior to Octotber 182013
- US Serial numbers
4405531144055611440558114405601244056312440566124405671244056812440573124405781244058012440582124405831244059212440593124405961244059712440598124405991244060012440601124406031244060412
- International Serial numbers44000811, 44055211, 44055411, 44055711, 44055911, 44056112, 44056212, 44056412, 44056512, 44056912, 44057012, 44057112, 44057212, 44057412, 44057512, 44057612, 44057712, 44057912, 44058112, 44058512, 44058612, 44058912,
44059012.4405911244059412440595124406021244060512440611124406121244061312440615124406171244061913440621134406231344062513440629134406301344060612440607124406091244061012440614124406161244061812440620134406221344062613440628134406331344063513440636134406371344063913
- Amount recalled
- 78 (39 in US, 39 internationally)
Where it was sold
Why it was recalled
Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
This product could cause temporary or reversible health problems — stop using it.
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