Bausch + Lomb recalls 27-gauge sterile cannula packed in Amvisc and Amvisc Plus OVDsJanuary 23, 2013
Bausch + Lomb is notifying heath care professionals of a Class I recall of certain Bausch + Lomb 27-gauge sterile cannula packed in the company’s Amvisc 1.2 percent Sodium Hyaluronate (models 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6 percent Sodium Hyaluronate (models 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical devices (OVDs).
The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidences, detachment has resulted in serious patient injury.
Amvisc and Amvisc Plus are indicated for use as surgical aids in ophthalmic anterior and posterior segment surgery including cataract extraction, intraocular lens (IOL) implantation—for smooth in-the-bag placement of IOLs, corneal transplantation and glaucoma filtering surgery, and surgical procedures to reattach the retina.
Due to its lubricating and viscoelastic properties, transparency and ability to protect corneal endothelial cells, Amvisc and Amvisc Plus help maintain anterior chamber depth and visibility, minimize interaction between tissues, and act as tamponade and vitreous substitutes during retina reattachment surgery. The 27-gauge disposable cannula is only used during surgery.
Optometrists, who often provide first-day post-operative care, should be aware of this potential for injury or complication during a surgical procedure, according to the AOA Advocacy Group. If operative injuries are observed post-operatively or reported by the patient, optometrists should be sure the injury was reported to the FDA as outlined in the information below.
The recall was announced Jan. 23, 2013.
The FDA MedWatch safety alert, including a link to the Recall Notice (with a list of affected lot numbers), can be accessed at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336466.htm.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of any health care products to the U.S. Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online: www.fda.gov/MedWatch/report.htm
- Download form (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery) or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178.