Z-0553-2010

Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY...

Name: Z-0553-2010 Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY...
Creator: Bausch & Lomb Inc
Published: 2009-10-30
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2009-10-30 / Terminated

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl... on 2009-10-30. The reason FDA records is "The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0553-2010
Status: Terminated
Initiated: 2009-10-30
Posted: 2009-12-22
Terminated: 2012-08-29
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.
Product code: MRC Products, Contact Lens Care, Rigid Gas Permeable
Reason for recall: The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
FDA root cause: Other
Action: Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.
Quantity in commerce: 159,672 bottles
Distribution: U.S. Nationwide, Canada and Hong Kong
Product codes and lots: All lots

Product code MRC

K983836Class IIRigid Gas Permeable Contact Lens SolutionPolymer Technology Div. Wilmington Partners, L.P. / cleared 1999-02-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)