Reported Dec 26, 2012 · Terminated
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the…
Bausch & Lomb 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: Bausch & Lomb Inc · 1400 North Goodman Street · Rochester, NY · 14609-3547
Is this the product you have?
- Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
- Lot codes and dates
- Installed by field service 1/3/12-8/8/12
- Serial numbers
124 of 124 codes
PFM00034PFM00038PFM00043PFM00047PFM00052PFM00056PFM00063PFM00067PFM00076PFM00082PFM00085PFM00099PFM00102PFM00110PFM00131PFM00134PFM00140PFM00141PFM00142PFM00143PFM00160PFM00163PFM00168PFM00170PFM00174PFM00175PFM00177PFM00182PFM00183PFM00194PFM00197PFM00201PFM00203PFM00204PFM00232PFM00233PFM00239PFM00245PFM00246PFM00249PFM00263PFM00265PFM00271PFM00276PFM00278PFM00285PFM00293PFM00297PFM00299PFM00305PFM00313PFM00323PFM00327PFM00333PFM00334PFM00336PFM00338PFM00350PFM00365PFM00401
- Amount recalled
- 124 units
Why it was recalled
Posterior fluidics modules installed in the system may need to be recalibrated.
This product could cause temporary or reversible health problems — stop using it.
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