MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for ALLEGRO OCULYZER 8065990641 manufactured by Wavelight Gmbh.
[90676519]
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 manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90676520]
A clinic's engineer/technician reported non-trusty measurement results during diagnostic testing on seven patients. There is no possibility to re-measure correctly. All the required step-by-step troubleshooting was done but the problem still remains and unit is unstable. Upon follow up, it was reported that measurements were not used for the patients surgery. No unexpected end results occurred. No patient harm reported. Seven patients were reported involved. There were no unexpected end results reported. No patient information was available as the doctor did not use results of measurements because they were not trusty. Another piece of equipment was used for diagnostics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2017-02254 |
| MDR Report Key | 6964846 |
| Date Received | 2017-10-20 |
| Date of Report | 2018-02-16 |
| Date of Event | 2017-09-22 |
| Date Mfgr Received | 2018-02-02 |
| Device Manufacturer Date | 2009-09-21 |
| Date Added to Maude | 2017-10-20 |
| 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 OCULYZER |
| Generic Name | DEVICE, ANALYSIS, ANTERIOR SEGMENT |
| Product Code | MXK |
| Date Received | 2017-10-20 |
| Returned To Mfg | 2018-01-29 |
| Model Number | NA |
| Catalog Number | 8065990641 |
| Lot Number | ASKU |
| ID Number | NA |
| Device Availability | R |
| 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 | 2017-10-20 |