MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-10 for ALLEGRO TOPOLYZER VARIO 8065990710 manufactured by Wavelight Gmbh.
| Report Number | 3003288808-2019-00708 |
| MDR Report Key | 8776836 |
| Date Received | 2019-07-10 |
| Date of Report | 2019-09-26 |
| Date of Event | 2019-06-20 |
| Date Mfgr Received | 2019-09-16 |
| Device Manufacturer Date | 2012-04-26 |
| Date Added to Maude | 2019-07-10 |
| 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 | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| 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 | 0 |
| Brand Name | ALLEGRO TOPOLYZER VARIO |
| Generic Name | TOPOGRAPHER, CORNEAL, AC-POWERED |
| Product Code | MMQ |
| Date Received | 2019-07-10 |
| Model Number | NA |
| Catalog Number | 8065990710 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-07-10 |