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.
This recall has been terminated (originally issued May 27, 2010).
- Company
- Bausch & Lomb Inc
- Recall Initiated
- April 20, 2010
- Posted
- May 27, 2010
- Terminated
- April 27, 2016
- Recall Number
- Z-1705-2010
- Quantity
- 2575 buttons
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
Distribution
Nationwide Distribution -- TX, IN and WI.
Lot / Code Info
Lot Number: 156PTC05.
Root Cause
Process control
Action Taken
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.
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