Recall Z-2405-2016 ยท HQF Laser, Ophthalmic
Topcon Medical Laser Systems, Inc
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
| Date | Jul 15, 2016 |
| Status | Terminated |
| Reason | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode. |
| Root cause | Device Design |
| Action | The firm, PASCALS Synthesis, sent an "Urgent Field Safety notification" letter dated July 15, 2016 to all affected sites by traceable method. The letter described the product, problem and actions to be taken. The customers were instructed to Acknowledge the receipt of the field notice via an official letter; locate all systems with Endpoint Management software feature enabled; for all affected units- inform the physician, hospital or institution customers of the addendum and additional warnings issued as a result of this notice; obtain signed confirmation from the end-user regarding receipt |
| Quantity | 205 units (21 in US, 184 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Japan, Netherlands, Algeria, Australia, Brazil, Chile, China, France, Guatemala, Hong Kong, Italy, New Zealand, Pakistan, Philippines, Singapore, Taiwan, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER Topcon Medical Laser Systems, Inc., May 15, 2013 |