Z-0672-2013 Class I Terminated
FDA device recall Z-0672-2013 was initiated by Bausch and Lomb, Incorporated on November 15, 2012 and is designated Class I. 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 ca… The recall status is terminated (terminated December 4, 2013). Affected quantity: 2,515,760.
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2013
- Initiation Date
- November 15, 2012
- Termination Date
- December 4, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,515,760
Product Description
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.
Distribution Pattern
Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.
Code Information
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, B110048A, B110048D, B110056A, B120011D, B120016A, B120046C, C100039A, C100039B, C10003B, C100046A, C100046B, C100046C, D090095B, D090096A, D090096C, D090097C, D090097D, D090097E, D090097G, D090105B, D090105C, D090105D, D100007B, D100007C, D100008A, D100008B, D100009A, D100011A, D100011B, D100011C, D100016A, D100016B, D100016C, D100016D, D100022A, D100022B, D100022C, D100022D, D100026A, D100026B, D100026C, D100026D, D100026E, D100030A, D100030B, D100030C, D100035A, D100035B, D100035C, D100035D, D100043A, D100043B, D100043C, D100044A, D100044B, D100044C, D100044D, D100044E, D100045A, D100045B, D100045C, D100045D, D100059A, D100059B, D100059C, D100060A, D100060B, D100061A, D100061B, D100080A, D100081A, D100081AR, 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, D120056B, D120068A, D120068B, E090105A, E100016A, E100016B, E100035A, E100035B, E100035C, E100045A, E100045B, E100059A, E100059B, E100060A, E100060B, E100060C, E100061A, Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L)