Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Surgical Procedure Packs

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Alcon Surgical Procedure Packs see related information
Date Initiated by Firm September 21, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on March 24, 2016
Recall Number Z-0195-2016
Recall Event ID 72363
510(K)Number K880961  
Product Classification General surgery tray (kit) - Product Code LRO
Product Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Code Information 1792733H, 1783925H, 1785227H, 1786729H
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Customer Service
800-862-5266
Manufacturer Reason
for Recall		 The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The recalling firm notified the consignee on 9/21/15 via phone call, and with a follow up visit to the consignee site. The recalled units were recovered.
Quantity in Commerce 5 units
Distribution Distributed in VT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = ALCON LABORATORIES
-
-