Z-1106-05

Staarvisic II Sodium Hyaluronate, 0.8 mL

Name: Z-1106-05 Staarvisic II Sodium Hyaluronate, 0.8 mL
Creator: Staar Surgical Co Inc
Published: 2005-07-18
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2005-07-18 / Terminated / root cause: sterility

FDA source

Staar Surgical Co Inc began a recall of Staarvisic II Sodium Hyaluronate, 0.8 mL on 2005-07-18. The reason FDA records is "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1106-05
Status: Terminated
Initiated: 2005-07-18
Posted: 2005-08-06
Terminated: 2012-07-25
Recalling firm: Staar Surgical AG
Product: Staarvisic II Sodium Hyaluronate, 0.8 mL
Product code: LZP Aid, Surgical, Viscoelastic
Reason for recall: Sterility may be compromised.
Root cause tag: sterility
FDA root cause: Other
Action: Recall will be communicated by telephone, email and letter. A fax back form will be used to track response and to identify ammount on hand.
Quantity in commerce: 16,464
Distribution: Nationwide, Canada and Puerto Rico
Product codes and lots: Lot B041118C Exp Date 12/31/2005

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)