Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 5

FDA device recall Z-0672-2013 · posted 2013-01-17 · Terminated

Recall details

Recalling firm

Bausch and Lomb, Incorporated

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.

Action taken

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 be expedited directly to your facility or your Bausch & Lomb Sales Representative will contact you shortly to furnish replacements and properly dispose of the cannulas with 4-digit lot numbers in your product inventory. Please feel free to contact Customer Service with any questions or concerns at (800) 338-2020 (option 2, followed again by Option 2).

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HMX

Quantity affected

2,515,760

Distribution

Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.

Date initiated

2012-11-15

Date posted

2013-01-17

Date terminated

2013-12-04

Location

Aliso Viejo, CA