Bausch + Lomb Stellaris PC Vision Enhancement System recall
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of…
Why was Bausch + Lomb Stellaris PC Vision Enhancement System recalled?
Posterior fluidics modules installed in the system may need to be recalibrated.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Installed by field service 1/3/12-8/8/12. Serial numbers: PFM00034, PFM00038, PFM00043, PFM00047, PFM00052, PFM00056, PFM00063, PFM00067, PFM00076, PFM00082, PFM00085, PFM00099, PFM00102, PFM00110, PFM00131, PFM00134, PFM00140, PFM00141, PFM00142, PFM00143, PFM00160, PFM00163, PFM00168, PFM00170, PFM00174, PFM00175, PFM00177, PFM00182, PFM00183, PFM00194, PFM00197, PFM00201, PFM00203, PFM00204, PFM00232, PFM00233, PFM00239, PFM00245, PFM00246, PFM00249, PFM00263, PFM00265, PFM00271, PFM00276, PFM00278, PFM00285, PFM00293, PFM00297, PFM00299, PFM00305, PFM00313, PFM00323, PFM00327, PFM00333, PFM00334, PFM00336, PFM00338, PFM00350, PFM00365, PFM00401, PFM00410, PFM00412, PFM00413, PFM00419, PFM00427, PFM00428, PFM00429, PFM00438, PFM00439, PFM00442, PFM00455, PFM00458, PFM00470, PFM00472, PFM00474, PFM00480, PFM00490, PFM00505, PFM00511, PFM00515, PFM00526, PFM00534, PFM00536, PFM00543, PFM00545, PFM00551, PFM00552, PFM00561, PFM00563, PFM00566, PFM00577, PFM00586, PFM00598, PFM00606, PFM00614, PFM00619, PFM00643, PFM00646, PFM00656, PFM00660, PFM00667, PFM00668, PFM00684, PFM00685, PFM00690, PFM00713, PFM00717, PFM00725, PFM00751, PFM00757, PFM00769, PFM00770, PFM00775, PFM00784, PFM00786, PFM00787, PFM00812, PFM00821, PFM00831, PFM00881, PFM00884, PFM00918, PFM00923, and PFM00930
- Product
- Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of…
- Recalling firm
- Bausch & Lomb Inc
- Quantity
- 124 units
- Distribution
- Worldwide Distribution was made in the U.S., Canada, Australia, Singapore, Korea, Switzerland, France, Germany, United Kingdom, Portugal, Italy, Spain, Ireland, Africa, UAE, Jordan, Turkey, Ukraine, and Lebanon. There was no government or military distribution.
- Recall date
- December 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)