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 ALLEGRETTO WAVE EYE-Q EXCIMER LASER 8065990739 manufactured by Wavelight Gmbh.
[187085426]
The device history records (dhr) for the device were reviewed. The associated device was released based on acceptance criteria. A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to treatment date. The root cause could not be identified conclusively. No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187085427]
An optometrist reported a patient presented with blurry vision in the left eye eight years post lasik. The patient was noted to have ectasia. Additional information requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2020-00239 |
| MDR Report Key | 9896868 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2008-09-15 |
| 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 | ALLEGRETTO WAVE EYE-Q EXCIMER LASER |
| Generic Name | OPHTHALMIC EXCIMER LASER SYSTEM |
| Product Code | LZS |
| Date Received | 2020-03-30 |
| Model Number | NA |
| Catalog Number | 8065990739 |
| 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. Other | 2020-03-30 |