Z-3089-2011

Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile...

Name: Z-3089-2011 Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile...
Creator: Bausch & Lomb Inc
Published: 2011-07-27
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2011-07-27 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use... on 2011-07-27. The reason FDA records is "The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction". 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-3089-2011
Status: Terminated
Initiated: 2011-07-27
Posted: 2011-08-30
Terminated: 2013-06-21
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
Product code: HQC Unit, Phacofragmentation
Reason for recall: The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.
Quantity in commerce: 2/6-unit cases
Distribution: Nationwide Distribution.
Product codes and lots: Model # BL5112, Lot #U6476, Exp. 11/2012

Product code HQC

K082473Class IIBausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. / cleared 2009-01-05

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)