Recall Z-1774-2013 ยท HQF Laser, Ophthalmic
Topcon Medical Laser Systems, Inc
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
| Date | Jul 19, 2013 (initiated Mar 27, 2012) |
| Status | Terminated |
| Reason | When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment. |
| Root cause | Software design |
| Action | Initial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented. |
| Quantity | 7 US, 33 foreign |
| Distribution | Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR Optimedica Corporation, May 4, 2010 |