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 |