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Recall Observatory FDA recall evidence

Device 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.

Z-0672-2013

November 15, 2012

Class I

Product summary

Firm
Bausch and Lomb, Incorporated
Event
Event 63698
Status
Terminated
Classification
Class I
Quantity
2,515,760
Official record key
device-enforcement:Z-0672-2013

Official wording

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.

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)

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.