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Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD): Class I Recall - Cannulas May Leak or Detach From the Syringe
includes 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
AUDIENCE: Risk Manager, Eye Care
ISSUE: Bausch and Lomb notified heathcare professionals of a Class I recall of certain Bausch and Lomb 27G Sterile Cannula Packed in Bausch and Lomb Amvisc 1.2 percent Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6 percent Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Ophthalmic Viscosurgical Device. See Recall Notice for list of affected lot numbers.
The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidences, detachment has resulted in serious patient injury.
BACKGROUND: 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.
RECOMMENDATION: Bausch and Lomb advised customers to discontinue the use and either destroy or quarantine the product under refrigeration pending a Sales Representative visit to your site.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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