—#95400

Product

Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.

FDA product code: LZP — Aid, Surgical, Viscoelastic
Device class: Class 3
Medical specialty: Ophthalmic
PMA numbers: P960011
Affected lot / code info: Lot No. Exp. Date RDOl71B 2012-12; RD0070A 2012-05; RD0018A 2012-02; RD0007A 2012-01 RC0064C 2011-06; RC0004A 2011-01;

Why it was recalled

Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.

Root cause (FDA determination)

Component design/selection

Action the firm took

Beaver Visitec issued an Urgent: Field Safety Notice letter, dated 10/4/10 to direct accounts, identifying the affected product and informing users of the potential for the finger grip to disengage during use. The firm offers solutions as follows: Allow the finger grip to remain attached to the syringe and continue to use the product. Position the open side of the finger grip towards the palm to avoid detachment of the grip from the syringe. Remove the finger grip and continue to use the product. Return the unused product to Beaver-Visitec for reimbursement. Users were requested to complete the Customer Response Form. Questions can be directed to: Inside Sales at 781-906-7952.

Recalling firm

Firm: Becton Dickinson and Company
Address: 411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-10-04
Posted by FDA: 2010-12-16
Terminated: 2012-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.