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 |