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,

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.

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.