Recall Z-1932-2010 ยท HQC Unit, Phacofragmentation
Alcon Research LTD dba Alcon Laboratories, Inc.
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.
| Date | Jul 13, 2010 (initiated Apr 30, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 contact |
| Quantity | 824 units total |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063583 | ALCON VISION SYSTEM Alcon, May 9, 2008 |