Z-1597-2010

BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in cataract surgery to...

Name: Z-1597-2010 BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in cataract surgery to...
Creator: Becton Dickinson and Company
Published: 2010-04-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-04-06 / Terminated / root cause: packaging

FDA source

Becton Dickinson and Company began a recall of BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in cataract surgery to create self-sealing stab incisions through the... on 2010-04-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1597-2010
Status: Terminated
Initiated: 2010-04-06
Posted: 2010-05-13
Terminated: 2012-08-06
Recalling firm: Becton Dickinson & Co
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.
Product code: HNN Knife, Ophthalmic
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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].
Quantity in commerce: 1170 (US 810, OUS 360)
Distribution: Worldwide Distribution -- United States, Canada and Japan.
Product codes and lots: Model # 585230, Lot 9202221

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)