MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-27 for WAVELIGHT FS200 FEMTOSECOND LASER 8065990714 manufactured by Wavelight Gmbh.
[186332764]
No abnormalities that could have contributed to this event were found during the device history records review and the product was released according to company's acceptance criteria. A review of the technical service on-site history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after the day of the treatment. The root cause could not be identified conclusively. The manufacturer internal reference number is: 2020-17720.
Patient Sequence No: 1, Text Type: N, H10
[186332765]
A risk manager reported a patient presented with rainbow glare five days post uneventful lasik. Glare was noted to be worse in the left eye than right eye. There are two related reports for this patient. This report addresses the patient's left eye and another manufacturer report will be filed for the fellow eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2020-00235 |
| MDR Report Key | 9888065 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-27 |
| Date Facility Aware | 2020-02-27 |
| Report Date | 2020-03-18 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-06-07 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | WAVELIGHT GMBH |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVELIGHT FS200 FEMTOSECOND LASER |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT |
| Product Code | GEX |
| Date Received | 2020-03-27 |
| Model Number | NA |
| Catalog Number | 8065990714 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH |
| Manufacturer Address | AM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-27 |