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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.

FDA Recall Z-1705-2010 · Posted 2010-05-27

Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHQD
Date Initiated2010-04-20
Date Terminated2016-04-27
Product Quantity2575 buttons

Reason for Recall

The amount of D&C #6 Dye added to the formulation exceeded specified amounts.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- TX, IN and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943177BOSTON(R) 7 - 30(ENFLUFOCON A)Polymer Technology Corp. · 1994-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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