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FDA Smacks Bausch & Lomb With a Recall


1/24/2013 8:18:22 AM

January 24, 2013 -- Recall Class: Class I

Date Recall Initiated: November 15, 2012

Products:

Bausch and Lomb 27G sterile cannula packed in Bausch and Lomb:

Amvisc 1.2% Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L)

Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device.

Lot numbers include:

B100003G, B100015A, B100015D, B100023A, B100023B, B100023C, B100023D, B100023E, B100039D, B100039F, B100046A, B100046B, B100046C, B100058A, B100069A, B110027D, B110028C, B110048A, B110048D, B110056A, B12,0011D, 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

Use: The 27G disposable, small tube (cannula) is provided with Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD). The OVD is a sterile gel-like substance (viscoelastic preparation) supplied in a disposable glass syringe either 0.5 or 0.8 mL of thick solution with water-retention properties (sodium hyaluronate). The 27G disposable cannula is attached to the syringe by a standard luer fitting to deliver the Amvisc or Amvisc Plus used as a surgical aid in the front part of the eye (anterior) or behind the iris (posterior) during eye surgery, such as cataract surgery.

Recalling Firm:

Bausch & Lomb, Inc.

1400 N. Goodman Street

Rochester, NY 14609

Manufacturer of the Cannula:

Rhein Medical, Inc.

3360 Scherer Dr., Suite B

St. Petersburg, Florida 33634-5215

Manufacturer of the OVD (Amvisc and Amvisc Plus):

Lifecore Biomedical, LLC.

3515 Lyman Blvd.

Chaska, Minnesota 55318-3050

Manufacturer of the OVD (Amvisc and Amvisc Plus):

Anika Therapeutics, Inc.

32 Wiggins Ave.

Bedford, Massachusetts 01730-2315

Reason for Recall: Some disposable cannulas provided with the Amvisc or Amvisc Plus OVD with a 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 incidences, detachment has resulted in serious patient injury.

Public Contact:

Bausch and Lomb, Inc.

(585) 338-8731

FDA District: Minneapolis District Office

FDA Comments: On November 14, 2012, Bausch and Lomb initially notified the customers by telephone using the recall notification letter as a script. Actual mailing by email or US mail started on November 15, 2012. The letter described the problem and product affected. Customers were advised that the recall was limited to cannulas from the above lot numbers. Bausch and Lomb advised customers to discontinue the use and either destroy or quarantine the product under refrigeration pending a Sales Representatives visit to your site. The sales representative would furnish replacements and properly dispose of the cannulas in your product inventory. The firm requested customers to complete and return the Recall and Field Correction Acknowledgement Form.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.



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