BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in cataract surgery to create self-sealing stab incisions through the cornea or sclera. Also used in retinal surgery for sclerotomy incisions.
FDA Recall Z-1597-2010 · Posted 2010-05-13
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Recalling FirmBecton Dickinson and Company
Recall StatusTerminated
Product CodeHNN
Date Initiated2010-04-06
Date Terminated2012-08-06
Product Quantity1170 (US 810, OUS 360)
Reason for Recall
A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and that some of the BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918.
Firm Action
BD Medical issued a "Voluntary Advisory Notice" dated April 6, 2010. Consignees were informed of the affected product and asked to complete the enclosed Customer Response Form indicating whether the product will be returned to the firm.
For further information, contact BD Medical Opthalmic Systems at 1-781-906-7952 or via email at [email protected].
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution -- United States, Canada and Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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