MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for ALLEGRO OCULYZER 8065990641 manufactured by Wavelight Gmbh.
[118530738]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118530739]
A customer reported the index of height decentration (ihd) was abnormal. The value is greater than 0. 014 in six to seven patients out of ten patients. The issue was discovered in normal eyes too. Additional information received states there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003288808-2018-01514 |
| MDR Report Key | 7819480 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-12-06 |
| Date Mfgr Received | 2018-11-28 |
| Device Manufacturer Date | 2012-03-16 |
| Date Added to Maude | 2018-08-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRYAN BLAKE |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW D-14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-14513 |
| 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 | 0 |
| Brand Name | ALLEGRO OCULYZER |
| Generic Name | DEVICE, ANALYSIS, ANTERIOR SEGMENT |
| Product Code | MXK |
| Date Received | 2018-08-27 |
| Model Number | NA |
| Catalog Number | 8065990641 |
| Lot Number | NA |
| 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 | 2018-08-27 |