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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Event Detail

Event ID 63698
Product Type Devices
Status Ongoing
Recalling Firm Bausch and Lomb, Incorporated
City Aliso Viejo
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. B100003G B100015A B100015D B100023A B100023B B100023C B100023D B100023E B100039D B100039F B100046A B100046B B100046C B100058A B100069A B110027D B110028C B110048A B110048D B110056A B120011D B120016A D100008B D100009A D100011A D100011B D100011C D100016B D100016C D100022A D100022B D100022C D100022D D100026A D100026C D100026D D100026E D100030A D100030B D100030C D100035A D100035C D100035D D100043A D100043B D100043C D100044B D100044C D100044D D100044E D100045A D100045B D100045C D100059A D100059B D100059C D100060A D100060B D100061A D100061B D100080A D100081A D100081AS D110015A D110015B D110016A D110045A D110046A D110047A D110070A D110071A D110072A D110090A D110090B D110091A D110092A D110108A D110108B D110108BR D120015A D120015B D120027A D120028A D120029A D120029B D120038B D120039A D120068A D120068B 023632 023633 023639 023640 023647 023801 023811 023863 023886 023897 023920 023933 023972 024022 024025 024028 024257 024323 024436 C10003B E090105A D090095B D090096A D090096C D090097C D090097D Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Class I 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. 2,342,294 Z-0672-2013