| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | REVLITE | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | HOYA CONBIO | LXS | REVLITE | 661-0025 | N | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-03-02 | 0 | 1. O |
Patient 1
IT WAS NOT NECESSARY TO RETURN THE SYSTEM TO BE EVALUATED. THE EVAL WAS PERFORMED ON AN EQUIVALENT SYSTEM AT THE FACTORY, THE ANOMALY DUPLICATED AND THEN CORRECTED WITH SOFTWARE UPGRADE. A NOTIFICATION LETTER IS BEING SENT TO THE AFFECTED USERS TO INFORM THEM OF THE ANOMALY AND HOW TO SAFELY USE THE SYSTEM UNTIL THEIR SOFTWARE CAN BE UPGRADED IN THE FIELD.
Patient 1
WHILE THE LASER WAS BEING TESTED AT THE (B)(6), THE TECHNICIAN OBSERVED THAT THE LASER WAS EMITTING 532NM WAVELENGTH ENERGY BUT THE CONTROL PANEL INDICATED THAT 1064NM WAS SELECTED. THERE WAS NO INJURY INVOLVED AND THERE ARE NO REPORTS OF THIS OCCURRING AT ANY CUSTOMER FACILITIES. A RISK ANALYSIS WAS PERFORMED TO DETERMINE THE POSSIBLE OUTCOMES OF THIS ANOMALY AND IT WAS DETERMINED THAT THE RISK WAS MINOR AND THE WORST CASE WOULD BE THE POTENTIAL FOR MINOR BLISTERING OF THE SKIN. THERE IS NO RISK OF EYE INJURY BECAUSE THE NORMAL EYEWEAR USED IN DUAL WAVELENGTH AND THE DYE HAND PIECE WOULD BLOCK THE 1064NM WAVELENGTH IF THEY ARE IN USE. AN ADVISORY LETTER IS BEING SENT TO THE CURRENT USERS THAT ARE AFFECTED THAT DESCRIBES THE ANOMALY AND HOW THE SYSTEM CAN BE IN STALLED. THE SOFTWARE HAS BEEN CORRECTED, TESTED AND RELEASED AND THE SERVICE DEPARTMENT WILL INSTALL THE UPGRADE AS SOON AS POSSIBLE.