MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-07 for ALLEGRO OCULYZER 8065990641 manufactured by Wavelight Gmbh.
[110384847]
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. Manufacturing record reviewed. No abnormalities that could have contributed to this event were found. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110384848]
A doctor reported that measurements are not correct. Upon follow up, problem occurred during measurements on the patient prior to the procedure. Procedure was completed a few minutes later. Patient was not affected.
Patient Sequence No: 1, Text Type: D, B5
[122682242]
After test measurements with test object, examination showed data gaps red and bad detection. If data gaps shows, the measurements are insufficient for use by the laser, thus, no patient will be affected. The sample was forwarded to supplier for repair. The supplier cleaned the complete optics, replaced the board, the slit projector housing, the camera assembly, the aluminum disc with the loop track and steel inserts and the motor bearing. The supplier also performed adjustment and calibration of the system. The root cause could not be determined conclusively as the supplier did not provide any details about root cause. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003288808-2018-01086 |
| MDR Report Key | 7578872 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-07 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2007-07-17 |
| Date Added to Maude | 2018-06-07 |
| 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 | MR. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 OCULYZER |
| Generic Name | DEVICE, ANALYSIS, ANTERIOR SEGMENT |
| Product Code | MXK |
| Date Received | 2018-06-07 |
| Returned To Mfg | 2018-07-03 |
| Model Number | NA |
| Catalog Number | 8065990641 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-06-07 |