Bausch + Lomb Stellaris PC Vision Enhancement System — Class II medical device recall Z-0593-2013
Terminated recall by Bausch & Lomb Inc, reported 2012-12-26. Posterior fluidics modules installed in the system may need to be recalibrated.
| Recall number | Z-0593-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Inc, Rochester, NY, United States |
| Recall initiated | 2012-08-31 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-07-11 |
| Countries outside the US | AE, AU, CA, CH, DE, ES, FR, GB, IE, IT, JO, KR, LB, PT, SG, TR, UA |
| Quantity | 124 units |
| 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 and 99 more |
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.
Reason for recall
Posterior fluidics modules installed in the system may need to be recalibrated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0593-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.