MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-05-01 for ALLEGRO OCULYZER 8065990641 manufactured by Wavelight Gmbh.
[3406110]
A healthcare professional reported irregular images and measurements with system use. Per technical service representative the customer used another system to obtain a reliable measurement.
Patient Sequence No: 1, Text Type: D, B5
[10762178]
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 info becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003288808-2013-00209 |
| MDR Report Key | 3109432 |
| Report Source | 01,05 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-04-03 |
| Date Mfgr Received | 2013-04-03 |
| Date Added to Maude | 2013-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ARTHUR CIOCIOLA |
| Manufacturer Street | 6201 SOUTH FREEWAY, TC-40 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152442 |
| 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 | ANTERIOR EYE SEGMENT ANALYSIS SYSTEM |
| Product Code | MXK |
| Date Received | 2013-05-01 |
| Model Number | 8065990641 |
| Catalog Number | 8065990641 |
| Lot Number | NA |
| ID Number | 1.16R12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-05-01 |