FDA Device recall Z-0593-2013
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and re…
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and re… by Bausch And Lomb, citing posterior fluidics modules installed in the system may need to be recalibrated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0593-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-31 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bausch And Lomb |
| Distribution | n/a |
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
Posterior fluidics modules installed in the system may need to be recalibrated.
Identifiers
| code_info | Installed by field service 1/3/12-8/8/12. Serial numbers: PFM00034, PFM00038, PFM00043, PFM00047, PFM00052, PFM00056,…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Bausch And Lomb
- Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North…
FDA Drug · Class III · 2019-06-19 · Bausch And Lomb - Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0593-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.