Class 2 Device Recall Boston ES Rigid Gas Permeable Contact lens

• Date Initiated by Firm: April 20, 2010
• Date Posted: May 27, 2010
• Recall Status: Terminated on April 27, 2016
• Recall Number: Z-1705-2010
• Recall Event ID: 55538
• 510(K)Number: K943177
• Product Classification: Lens, contact (other material) - daily - Product Code HQD
• 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.
• Code Information: Lot Number: 156PTC05.
• Recalling Firm/ Manufacturer: Bausch & Lomb Inc; 1400 North Goodman Street; Rochester NY 14609-3547
• For Additional Information Contact: Doug Fortunato; 585-338-5477
• Manufacturer Reason for Recall: The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
• FDA Determined 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 in Commerce: 2575 buttons
• Distribution: Nationwide Distribution -- TX, IN and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HQD