Recall Z-0672-2013— Bausch and Lomb, Incorporated

Class I FDA medical device recall by Bausch and Lomb, Incorporated, initiated 2012-11-15, terminated 2013-12-04. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

Bausch and Lomb, Incorporated

Classification

Class I

Status

Terminated

Initiated

2012-11-15

Terminated

2013-12-04

Firm location

Aliso Viejo, CA, United States

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