Z-0593-2013Class II

Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended...

Name: Z-0593-2013 Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended...
Creator: Bausch & Lomb Inc
Published: 2012-08-31
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2012-08-31 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Inc began a recall of Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts... on 2012-08-31. FDA classified it as Class II and gives the reason as "Posterior fluidics modules installed in the system may need to be recalibrated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0593-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-31
Posted: 2012-12-20
Terminated: 2013-07-11
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HQC Unit, Phacofragmentation
Reason for recall: Posterior fluidics modules installed in the system may need to be recalibrated.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: "Urgent Product Recall" notification letters dated August 31, 2012 were issued via first class mail, e-mail, and/or phone calls to affected customers. The product issue and the field correction was provided. Customers in the US may contact 1-800 338-2020 for questions.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0593-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0593-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20

Product code HQC

K101325Class IIStellaris Pc Vision Enhancement SystemBausch & Lomb, Inc. / cleared 2010-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)