Z-0348-03

OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the...

Name: Z-0348-03 OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the...
Creator: Bausch & Lomb Inc
Published: 2002-11-26
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2002-11-26 / Terminated / root cause: labeling and UDI

FDA source

Bausch & Lomb Inc began a recall of OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each... on 2002-11-26. The reason FDA records is "Lenses labeled as -2.25 diopter contain -0.75 diopter lenses". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0348-03
Status: Terminated
Initiated: 2002-11-26
Posted: 2002-12-19
Terminated: 2003-06-23
Recalling firm: Bausch & Lomb Incorporated
Product: OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.
Quantity in commerce: 2,081 / 6-packs
Distribution: Nationwide distribution.
Product codes and lots: Lot R21000211

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)