MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-24 for ALLEGRO TOPOLYZER VARIO 8065990710 manufactured by Wavelight Gmbh.
[90105821]
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
[90105822]
A physician reported one diopter of over correction three weeks following topography guided lasik treatment. Additional information provided, inconsistent data was sent to the laser from the imaging system which was subsequently confirmed as a user error.
Patient Sequence No: 1, Text Type: D, B5
[112898748]
The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003288808-2017-02289 |
| MDR Report Key | 6973768 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-24 |
| Date of Report | 2018-02-14 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2017-10-24 |
| 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 | MS. NADIA BAILEY |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91058 |
| Manufacturer Phone | 8176152330 |
| 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 | ALLEGRO TOPOLYZER VARIO |
| Generic Name | TOPOGRAPHER, CORNEAL, AC-POWERED |
| Product Code | MMQ |
| Date Received | 2017-10-24 |
| Model Number | NA |
| Catalog Number | 8065990710 |
| Lot Number | ASKU |
| ID Number | 00380659907104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2017-10-24 |