Recall Z-0672-2013 ยท HMX Cannula, Ophthalmic
Bausch and Lomb, Incorporated
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
| Date | Jan 17, 2013 (initiated Nov 15, 2012) |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Bausch & Lomb, initially notified their customers via telephone November 14, 2012 and sent a follow-up letter entitled "URGENT VOLUNTARY PRODUCT RECALL AND FIELD CORRECTION" on November 15, 2012 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine the product; identify the affected cannulas; and complete and return the attached Recall and Field Correction Acknowledgment Form via Fax to (800) 822-8918 or email at: Luis.Leyva@bausch.com. Note: Based on your form selections, replacement cannulas will either b |
| Quantity | 2,515,760 |
| Distribution | Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.