BAUSCH + LOMB Biotrue ONEday lenses — Class II medical device recall Z-0206-2016
Terminated recall by Bausch & Lomb Inc Irb, reported 2015-11-11, distributed nationwide. The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical su
| Recall number | Z-0206-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Inc Irb, Rochester, NY, United States |
| Recall initiated | 2015-09-03 |
| Classified | 2015-11-04 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, TH |
| Lot numbers | W57209820 |
| Model numbers | 8098001, 8098203, 8101403 |
| Expiration dates | 2019-05-19, 2019-05-23, 2019-05-28, 2019-06-09, 2019-07-01 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0206-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.