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U.S. Department of Health and Human Services

Class 1 Device Recall Constellation Vision System

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  Class 1 Device Recall Constellation Vision System see related information
Date Initiated by Firm April 30, 2010
Date Posted July 13, 2010
Recall Status1 Terminated 3 on September 19, 2011
Recall Number Z-1932-2010
Recall Event ID 55648
510(K)Number K063583  
Product Classification unit, phacofragmentation - Product Code HQC
Product Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553

The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Code Information All lot/serial numbers
Recalling Firm/
Manufacturer		 Alcon Research LTD dba Alcon Laboratories, Inc.
15800 Alton Pkwy
Irvine CA 92618-3818
For Additional Information Contact
949-753-1393
Manufacturer Reason
for Recall		 Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
FDA Determined
Cause 2		 Software design
Action The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
Quantity in Commerce 824 units total
Distribution Worldwide distribution.
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 = HQC and Original Applicant = ALCON
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