BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.
FDA Recall Z-0206-2016 · Posted 2015-11-04
Advertisement
Recalling FirmBausch & Lomb Inc Irb
Recall StatusTerminated
Product CodeLPL
Date Initiated2015-09-03
Date Terminated2016-06-06
Product QuantityDomestic: 99,260 lenses; Foreign: 84,660 lenses
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.
Firm Action
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 [email protected]. Customers may also contact Bausch + Lomb Customer Service at 1-800-828-9030 to arrange return of affected product.
Root Cause
Process control
Distribution Pattern
Distributed US (nationwide), Canada, Japan and Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement