FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: 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.
- Recall number
- Z-0544-05
- Recalling firm
- Bausch & Lomb Inc
- 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.
- Status
- Terminated
- Initiated
- 2005-02-04
- Posted
- 2005-02-16
- Terminated
- 2005-10-28
- Reason
- Portion of lot contains lenses with incorrect refractive power.
- 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
- 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.
- Lot, serial or model codes
- Carton lot W44090230; Blister Lot W44089478
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28