FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887. Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes.
- Recall number
- Z-1705-2010
- Recalling firm
- Bausch & Lomb Inc
- Product
- Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887. Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes.
- Status
- Terminated
- Initiated
- 2010-04-20
- Posted
- 2010-05-27
- Terminated
- 2016-04-27
- Reason
- The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
- Root cause
- Process control
- Action
- Bausch & Lomb issued an "Urgent Voluntary Medical Device Recall" notification dated April 20, 2010. Consignees were informed of the issue and asked to identify and return all affected product to the firm. For further information, contact Bausch & Lomb, Inc. at 1-585-338-5477.
- Quantity
- 2575 buttons
- Distribution
- Nationwide Distribution -- TX, IN and WI.
- Lot, serial or model codes
- Lot Number: 156PTC05.
- 510(k) numbers
- ["K943177"]
- PMA numbers
- not on file
- Product code
- HQD
- 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