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U.S. Department of Health and Human Services

Class 2 Device Recall Boston ES Rigid Gas Permeable Contact lens

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  Class 2 Device Recall Boston ES Rigid Gas Permeable Contact lens see related information
Date Initiated by Firm April 20, 2010
Date Posted May 27, 2010
Recall Status1 Terminated 3 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/
Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Doug Fortunato
Manufacturer Reason
for Recall
The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
FDA Determined
Cause 2
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 and Original Applicant = POLYMER TECHNOLOGY CORP.