The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
FDA Recall Z-1702-2015 · Posted 2015-06-09
Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeLRO
Date Initiated2015-04-28
Date Terminated2016-03-24
Product Quantity219,680 units
Reason for Recall
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.
Firm Action
Alcon sent a Recall letter dated April 28, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a return form and instructions for credit. Customers were instructed to review inventory for any affected units, segregat the product to ensure it is not used, and return the attached Response Form via fax or email to Alcon.
For questions or need assistance with obtaining replacement products contact Alson Customer service at 800-862-5266.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Australia and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.