Recall Z-1540-2013 ยท LZS Excimer Laser System
Abbott Medical Optics, Inc.
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
| Date | Jun 13, 2013 (initiated May 28, 2013) |
| Status | Terminated |
| Reason | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. |
| Root cause | Other |
| Action | AMO Manufacturing sent an Advisory Notice dated May 28, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the attached advisory notice to all affected customers in their assigned region. Customers were instructed to notify each surgeion at their site and complete and return the attached form to AMO via fax as an an acknowledgement of receipt of this advisory notice and that they understand the information contained within the letter. Customers with questio |
| Quantity | 1,882 - total all systems |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.