Z-1224-06

Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy...

Name: Z-1224-06 Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy...
Creator: Medisurg Research & Management Corp
Published: 2006-04-28
License: https://open.fda.gov/license/

Medisurg Research & Management Corp / initiated 2006-04-28 / Terminated / root cause: sterility

FDA source

Medisurg Research & Management Corp began a recall of Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped... on 2006-04-28. The reason FDA records is "No documentation to support shelf life/sterility". 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-1224-06
Status: Terminated
Initiated: 2006-04-28
Posted: 2006-08-02
Terminated: 2006-09-08
Recalling firm: Medisurg Research & Management Corp
Product: Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per carton.
Product code: NCR Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
Reason for recall: No documentation to support shelf life/sterility
Root cause tag: sterility
FDA root cause: Other
Action: On 4/28/06, the recalling firm faxed a notification to the customers informing them not to use the product during surgery and to return the product.
Quantity in commerce: 960 tips
Distribution: Nationwide, including CA, CT, FL, GA, MA, NC, NY, OH, OR, PA, TX, and WI.
Product codes and lots: Lot numbers 01013786, 01017917, 01017918, 01017684 and 01017442

Product code NCR

K001498Class IIThe Fugo BladeMedisurg , Ltd. / cleared 2000-08-10

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)