CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery.
FDA Recall Z-1338-2011 · Posted 2011-02-16
Recalling FirmAspen Surgical Products, Inc.
Recall StatusTerminated
Product CodeHMR
Date Initiated2010-12-23
Date Terminated2011-10-07
Product Quantity77,850
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.