Z-1705-2010

Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable...

Name: Z-1705-2010 Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable...
Creator: Bausch & Lomb Inc
Published: 2010-04-20
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2010-04-20 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Inc began a recall of Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc... on 2010-04-20. The reason FDA records is "The amount of D&C #6 Dye added to the formulation exceeded specified amounts". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1705-2010
Status: Terminated
Initiated: 2010-04-20
Posted: 2010-05-27
Terminated: 2016-04-27
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HQD Lens, Contact (Other Material) - Daily
Reason for recall: The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot Number: 156PTC05.

Product code HQD

K943177Class IIBoston(r) 7 - 30(Enflufocon a)Polymer Technology Corp. / cleared 1994-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)