Recalls / —
—#90421
Product
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 product code
- HNN — Knife, Ophthalmic
- Device class
- Class 1
- Medical specialty
- Ophthalmic
- Affected lot / code info
- Model # 585230, Lot 9202221
Why it was recalled
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.
Root cause (FDA determination)
Packaging process control
Action the firm took
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 ahusebo@bd.com.
Recalling firm
- Firm
- Becton Dickinson and Company
- Address
- 411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448
Distribution
- Distribution pattern
- Worldwide Distribution -- United States, Canada and Japan.
Timeline
- Recall initiated
- 2010-04-06
- Posted by FDA
- 2010-05-13
- Terminated
- 2012-08-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #90421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.