Recall Z-1139-2008 ยท LZS Excimer Laser System
VISX INCORPORATED, A SUBSIDIARY OF AMO INC
AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051
| Date | Jun 5, 2008 (initiated Dec 13, 2007) |
| Status | Terminated |
| Reason | Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser. |
| Root cause | Component design/selection |
| Action | On December 13, 2007, firm issued an Urgent Safety Notice to all VISX and IntraLase laser owners related to recall. The Safety Notice contains information related to the measures that can be taken to prevent unintentional movement of any chair during other procedures. AMO is initiating a field corrective action, whereby Field Service Engineers will visit each practice that owns both systems to disable the VISX chair back switch. For additional information, please contact AMO at (714) 247-8656. |
| Quantity | 1,853 units |
| Distribution | Worldwide Distribution - USA, including the states of: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV and countries of: Argentina Australia Austria Bahrain Belgium Bolivia Brazil Bulgaria Canada Ch |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.