Z-0544-05

SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each...

Name: Z-0544-05 SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each...
Creator: Bausch & Lomb Inc
Published: 2005-02-04
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2005-02-04 / Terminated

FDA source

Bausch & Lomb Inc began a recall of SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS... on 2005-02-04. The reason FDA records is "Portion of lot contains lenses with incorrect refractive power". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0544-05
Status: Terminated
Initiated: 2005-02-04
Posted: 2005-02-16
Terminated: 2005-10-28
Recalling firm: Bausch & Lomb Incorporated
Product: SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS, -1.25DC, 170 degree Axis. Firm on label: Manufactured by Bausch & Lomb, Waterford, Ireland.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Portion of lot contains lenses with incorrect refractive power.
FDA root cause: Other
Action: Letters issued dated February 4, 2005. The letters are flagged 'URGENT MEDICAL DEVICE RECALL'. Distributors are instructed to notify their customers to the retail (practitioner) level. All customers are instructed to return product.
Quantity in commerce: 798 cartons distrib. by B&L, Rochester, NY
Distribution: There are 134 eye care practitioners, 191 mass retailers, 19 distributors, 14 consumers, and 3 mail order businesses.
Product codes and lots: Carton lot W44090230; Blister Lot W44089478

Product code LPL

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)