Class I — Bausch and Lomb, Incorporated
| Recalling firm | Bausch & Lomb Incorporated |
|---|---|
| Registered facility | Bausch & Lomb Incorporated (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury. |
| Product | Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures. |
| Quantity | 2,515,760 |
| Distribution | Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time. |
| Initiated | 2012-11-15 |
| Classified | 2013-01-17 |
| Terminated | 2013-12-04 |
| Recall number | Z-0672-2013 |
| 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 I recall — Bausch and Lomb, Incorporated (Z-0672-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63698/
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