Z-0606-2011

Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For...

Name: Z-0606-2011 Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For...
Creator: Becton Dickinson and Company
Published: 2010-10-04
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-10-04 / Terminated / root cause: design

FDA source

Becton Dickinson and Company began a recall of 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... on 2010-10-04. The reason FDA records is "Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0606-2011
Status: Terminated
Initiated: 2010-10-04
Posted: 2010-12-16
Terminated: 2012-02-16
Recalling firm: Becton Dickinson & Co
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.
Product code: LZP Aid, Surgical, Viscoelastic
Reason for recall: Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 72278 units
Distribution: Nationwide Distribution
Product codes and lots: Lot No. Exp. Date RDOl71B 2012-12; RD0070A 2012-05; RD0018A 2012-02; RD0007A 2012-01 RC0064C 2011-06; RC0004A 2011-01;

Product code LZP

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)