MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-18 for WAVELIGHT EX500 EXCIMER LASER 8065990713 manufactured by Wavelight Gmbh.
[184318231]
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
[184318232]
A physician reported a patient with a corneal scar in the right eye five months post photo refractive keratectomy (prk). The patient had phototherapeutic keratectomy (ptk) to remove the scar and is happy and vision is good. There are multiple patients for this reported event. This report addresses the patient pkr's left eye, and other manufacturer reports will be filed for the other patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2020-00206 |
| MDR Report Key | 9848457 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-06-27 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2012-11-06 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Model Number | NA |
| Catalog Number | 8065990713 |
| Lot Number | NA |
| 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 | 2020-03-18 |