BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lense

FDA device recall Z-0206-2016 · posted 2015-11-04 · Terminated

Recall details

Recalling firm

Bausch & Lomb Inc Irb

Reason for recall

The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.

Action taken

On 9/3/2015, the distributors received the Medical Device Recall Letter (dated 9/2/2015) via e-mail. Medical Device Recall Letters (dated 9/2/2015) and Customer Acknowledgement Cards were hand delivered to the direct customers via Bausch + Lomb Sales Representatives starting on 9/14/2015 or sent via FedEx if consignee is not a B+L account. The letter informs the accounts of the recall and instructs them to direct any consumers who would like to report a product complaint, arrange for a product exchange, or obtain more information on the product recall to contact the Bausch + Lombs Consumer Affairs Team at 1-800-553-5340 or via e-mail at BLCustomerCare@bausch.com. Customers may also contact Bausch + Lomb Customer Service at 1-800-828-9030 to arrange return of affected product.

Root cause

Process control

Status

Terminated

Product code

LPL

Quantity affected

Domestic: 99,260 lenses; Foreign: 84,660 lenses

Distribution

Distributed US (nationwide), Canada, Japan and Thailand.

Date initiated

2015-09-03

Date posted

2015-11-04

Date terminated

2016-06-06

Location

Rochester, NY

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