Bausch + Lomb Stellaris PC Vision Enhancement System Recall
Bausch & Lomb is recalling 124 Stellaris PC Vision Enhancement System modules because they may need recalibration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bausch & Lomb Inc is recalling 124 units of the Stellaris PC Vision Enhancement System, specifically the Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, as well as anterior and posterior segment vitrectomy.
The recall is being conducted because the posterior fluidics modules installed in the system may need to be recalibrated. The affected units were installed by field service between January 3, 2012, and August 8, 2012.
Distribution was made worldwide 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.
The recalled product
- Product
- 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.
- Manufacturer
- Bausch & Lomb Inc
- Hazard
- Affected units
- 124
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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