Z-0672-2013Class I

Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model...

Name: Z-0672-2013 Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model...
Creator: Bausch and Lomb, Incorporated
Published: 2012-11-15
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2012-11-15 / Terminated / root cause: manufacturing process

FDA source

Bausch and Lomb, Incorporated began a recall of 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%... on 2012-11-15. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0672-2013
Classification: Class I
Status: Terminated
Initiated: 2012-11-15
Posted: 2013-01-17
Terminated: 2013-12-04
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HMX Cannula, Ophthalmic
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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: [email protected]. 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).
Quantity in commerce: 2,515,760
Distribution: Worldwide distribution: USA including DC and PR; and countries of: Canada and Mexico accounts not available at this time.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0672-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0672-2013	Class I	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-17

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)