Recall Z-0206-2016 ยท LPL Lenses, Soft Contact, Daily Wear
Bausch & Lomb Inc Irb
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.
| Date | Nov 4, 2015 (initiated Sep 3, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| 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 A |
| Quantity | Domestic: 99,260 lenses; Foreign: 84,660 lenses |
| Distribution | Distributed US (nationwide), Canada, Japan and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS Bausch & Lomb, Incorporated, Jun 5, 2012 |