Z-1336-2011

Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic...

Name: Z-1336-2011 Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic...
Creator: Aspen Surgical Products, Inc.
Published: 2010-12-23
License: https://open.fda.gov/license/

Aspen Surgical Products, Inc. / initiated 2010-12-23 / Terminated / root cause: design

FDA source

Aspen Surgical Products, Inc. began a recall of Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery on 2010-12-23. The reason FDA records is "Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery". 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-1336-2011
Status: Terminated
Initiated: 2010-12-23
Posted: 2011-02-16
Terminated: 2011-10-07
Recalling firm: Aspen Surgical Products, Inc.
Product: Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery.
Product code: HMR Marker, Ocular
Reason for recall: Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Root cause tag: design
FDA root cause: Component design/selection
Action: Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers. The firm does not intend to continue manufacturing or distributing the product.
Quantity in commerce: 77,850 all products
Distribution: Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Product codes and lots: 2010-10-07, 2012-10-12, 2012-11-30, 2012-12-15, 2013-04-09, 2013-04-23, 2013-05-21, 2013-09-01, 2013-10-01.

Product code HMR

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)