Recall Z-1934-2010
Alcon Research LTD dba Alcon Laboratories, Inc. · initiated April 30, 2010
Product
Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 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.
Codes / lots: All lot/serial numbers
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: Software design
Action taken
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.
Details
- Recall number
- Z-1934-2010
- Initiated
- April 30, 2010
- Posted by FDA
- July 13, 2010
- Terminated
- September 19, 2011
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 824 units total
- Distribution
- Worldwide distribution.
- Recalling firm
- Alcon Research LTD dba Alcon Laboratories, Inc., Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1924-2010 | Constellation Vision System, Model: Constellation Vision System w/Laser, Catalogue…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1925-2010 | Constellation Vision System, Model: Constellation Vision System w/o Laser, Catalogue…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1926-2010 | Constellation Vision System, Model: Constellation Tabletop, Catalogue Number: 8065751150…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1927-2010 | Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1928-2010 | Constellation Vision System, Model: Constellation LT, Catalogue Number: 8065751549 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1929-2010 | Constellation Vision System, Model: Constellation LXT, Catalogue Number: 8065751550 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1930-2010 | Constellation Vision System, Model: Constellation LX, Catalogue Number: 8065751551 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1931-2010 | Constellation Vision System, Model: Constellation B, Catalogue Number: 8065751552 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1932-2010 | Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |
| Z-1933-2010 | Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | 04/30/2010Terminated |