MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for ALLEGRO TOPOLYZER VARIO 8065990710 manufactured by Wavelight Gmbh.
[86088408]
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 device history records (dhr) for the device was reviewed. The associated device was released based on company acceptance criteria. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86088409]
A surgeon reported incorrect readings and values during treatment planning for refractive treatment. Additional information received; the surgeon found the data inconsistent and did not use it for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2017-02013 |
| MDR Report Key | 6859384 |
| Date Received | 2017-09-12 |
| Date of Report | 2018-01-04 |
| Date Mfgr Received | 2017-12-28 |
| Device Manufacturer Date | 2014-11-24 |
| Date Added to Maude | 2017-09-12 |
| 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 | 0 |
| Brand Name | ALLEGRO TOPOLYZER VARIO |
| Generic Name | TOPOGRAPHER, CORNEAL, AC-POWERED |
| Product Code | MMQ |
| Date Received | 2017-09-12 |
| Model Number | NA |
| Catalog Number | 8065990710 |
| Lot Number | NA |
| 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 | 2017-09-12 |