FDA Recall
Terminated
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: Z-1705-2010
·
Initiated April 20, 2010
Recall
- Recall Number
- Z-1705-2010
- Event Number
- 55538
- Firm
- Bausch & Lomb Inc
- FEI Number
- 1317628
- Product Code
- HQD
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 20, 2010
- Posted
- May 27, 2010
- Terminated
- April 27, 2016
- Address
- 1400 North Goodman Street, Rochester, NY, 14609-3547
Description
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.
Reason
The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
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.
Distribution
Nationwide Distribution -- TX, IN and WI.
Quantity
2575 buttons