MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for WAVELIGHT EX500 EXCIMER LASER 8065990794 manufactured by Wavelight Gmbh.
[187086067]
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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187086068]
A director reported a patient had uneventful lasik in both eyes and an unremarkable routine one day follow up postoperative exam. The patient was seen at a one month postoperative visit and oils were noted under the flap of the left eye. The flap was lifted and rinsed. The patient was seen two days later and inflammation was noted. The flap was rinsed again. The patient was seen three days later and the patient was noted to have persistent corneal haze and was referred to a corneal specialist for fungal infection. The patient continues to be under the care of the corneal specialist for the fungal infection. Additional information requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2020-00244 |
| MDR Report Key | 9897089 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-04 |
| Date Facility Aware | 2020-01-07 |
| Report Date | 2020-03-09 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2015-12-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | NA |
| 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. Required No Informationntervention | 2020-03-30 |