MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-30 for WAVELIGHT EX500 EXCIMER LASER 8065990794 manufactured by Wavelight Gmbh.
[185499867]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Report related to mw5092720. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185499868]
A patient reported permanent corneal pain, cannot sleep at night, "profanity" night vision, huge halos, starburst, double vision at night, floaters, flashes, and lattice degeneration post lasik. The patient uses autologous serum eye drops to control the eye pain but it is not working. The patient noted having perfect night vision before lasik and that glasses cannot fix the night vision damage. The patient also noted not having floaters before lasik but now sees them when in bright sunlight, looking at the computer screen or windshield of the car and cannot play video games because of the eye pain. The patient stated that the laser burned the eyes, ruined the tear film, and natural shape of the eye. Blinking does not help and has to wear sunglasses while driving and is depressed. Additional information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2020-00245 |
| MDR Report Key | 9897163 |
| Report Source | OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-05-24 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| 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 EX500 EXCIMER LASER |
| Generic Name | OPHTHALMIC EXCIMER LASER SYSTEM |
| Product Code | LZS |
| Date Received | 2020-03-30 |
| Model Number | NA |
| Catalog Number | 8065990794 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2020-03-30 |