MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-20 for WAVELIGHT EX500 EXCIMER LASER 8065990794 manufactured by Wavelight Gmbh.
[184262917]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184262918]
A risk manager reported a patient had edema and haze in the left eye five days post photo refractive keratectomy (prk). The patient was referred back to surgeon. Visual acuity decreased in the left eye. The patient was diagnosed with (b)(6). The patient was started on an oral antiviral drug. Two topical antibiotic drops were prescribed. The patient is to continue using another antibiotic drop also and to discontinue another antibiotic and steroid drop. Defect healed a week later. Epithelium was noted to be intact. Haze still is present in the left eye and the patient continues to be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2020-00211 |
| MDR Report Key | 9859654 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-13 |
| Date Facility Aware | 2020-02-13 |
| Report Date | 2020-02-24 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2015-10-05 |
| Date Added to Maude | 2020-03-20 |
| 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 EX500 EXCIMER LASER |
| Generic Name | OPHTHALMIC EXCIMER LASER SYSTEM |
| Product Code | LZS |
| Date Received | 2020-03-20 |
| 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 | 2020-03-20 |