Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.

FDA device recall Z-1337-2011 · posted 2011-02-16 · Terminated

Recall details

Recalling firm

Aspen Surgical Products, Inc.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

HMR

Quantity affected

77850 all products

Distribution

Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.

Date initiated

2010-12-23

Date posted

2011-02-16

Date terminated

2011-10-07

Location

Caledonia, MI