Recall Z-1702-2015— Alcon Research, Ltd.

Name: FDA recall Z-1702-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-28

Class II · Terminated

Class II FDA medical device recall by Alcon Research, Ltd., initiated 2015-04-28, terminated 2016-03-24. It names one FDA 510(k) clearance: K880961. Product: 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.. Reason: 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..

Recalling firm: Alcon Research, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2015-04-28
Terminated: 2016-03-24
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K880961 — ALCON SURGICAL PROCEDURE PACKSAlcon Laboratories·cleared 1988-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.