Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb… — Class I medical device recall Z-0672-2013
Terminated recall by Bausch and Lomb, Incorporated, reported 2013-01-23, distributed in DC, PR. Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not proper
| Recall number | Z-0672-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch and Lomb, Incorporated, Aliso Viejo, CA, United States |
| Recall initiated | 2012-11-15 |
| Classified | 2013-01-17 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-12-04 |
| Distributed | DC, PR |
| Countries outside the US | CA, MX |
| Quantity | 2,515,760 |
| Reason classes | foreign material, sterility, packaging, device malfunction |
| Lot numbers | 23632, 23633, 23639, 23640, 23647, 23801, 23811, 23863, 23886, 23897, 23920, 23933, 23972, 24022, 24025, 24028, 24257, 24323, 24436, B100003C, B100003E, B100003G, B100015A, B100015D, B100023A, B100023B, B100023C, B100023D, B100023E, B100039C, B100039D, B100039F, B100046A, B100046B, B100046C, B100058A, B100069A, B100069E, B110027D, B110028C and 114 more |
| Model numbers | 59051, 59051L, 59081, 59081L, 60051, 60051L, 60081, 60081L |
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.
Reason for recall
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.
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-0672-2013. 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.