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 CONSTELLATION Vision System

  • 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 CONSTELLATION Vision System see related information
Date Initiated by Firm August 18, 2023
Date Posted October 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-0099-2024
Recall Event ID 93010
510(K)Number K141065  K101285  
Product Classification Unit, phacofragmentation - Product Code HQC
Product Constellation Vision System, REF: 8065751150
Code Information UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
Recalling Firm/
Manufacturer		 Alcon Research, LLC
15800 Alton Pkwy
Irvine CA 92618-3818
For Additional Information Contact Kristen Kellerhals
949-753-6372
Manufacturer Reason
for Recall		 Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
FDA Determined
Cause 2		 Component change control
Action Starting on 8/18/23, Field Service Engineers told customers their devices needed pneumatics module replacements, and this replacement activity was subsequently completed. On 9/29/23, correction notices were mailed to customers informing them vision systems were corrected and asking they complete and return the response form to Market.Actions@Alcon.com Should you have any questions or concerns call Customer Service at 1-800-862-5266.
Quantity in Commerce 3
Distribution US: GA, IL, PR
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = ALCON MANUFACTURING, LTD.
510(K)s with Product Code = HQC and Original Applicant = ALCON RESEARCH, LTD.
-
-