Class II — Bausch & Lomb Inc Irb
| Recalling firm | Bausch & Lomb Incorporated |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | Domestic: 99,260 lenses; Foreign: 84,660 lenses |
| Distribution | Distributed US (nationwide), Canada, Japan and Thailand. |
| Initiated | 2015-09-03 |
| Classified | 2015-11-04 |
| Terminated | 2016-06-06 |
| Recall number | Z-0206-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bausch & Lomb Inc Irb (Z-0206-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72161/
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