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Terminated

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 Recall Z-0606-2011 · Posted 2010-12-16

Recall StatusTerminated
Product CodeLZP
Date Initiated2010-10-04
Date Terminated2012-02-16
Product Quantity72278 units

Reason for Recall

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

Firm Action

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.

Root Cause

Component design/selection

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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