MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[24137510]
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. Additional information has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24137511]
An ophthalmic surgeon reported that there was an issue in the measurements repeatedly. Patients' and employees' measurements could not be repeated. There were differences from 1 to 1. 5 d. The patients' measurements were compared with a different device and the measurements were the same as the previous ones. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[28251045]
Evaluation summary: the device has not been returned, however data collection of the device was performed and analyzed by clinical application specialists. No anomalies found by review of device history record. Product met all specifications when released. Data of (b)(4) measurements were provided and analyzed. These showed that only (b)(4) measurements could be compared against the previous software version, all others did not provide green traffic light and therefore were not recommended to be used. The difference in measurements of sw 2. 5. 0 and 2. 6 differs by 0,2 - 0,5 d which is within accepted limits. Comparing preoperative measurements with postoperative measurements inherently differ by nature of the surgery and its healing process. No technical root cause could be determined.
Patient Sequence No: 1, Text Type: N, H10
[37069405]
The clock start date on the mdr was originally reported as (b)(6) 2015. The correct date should have been (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2015-00513 |
| MDR Report Key | 4995222 |
| Date Received | 2015-08-12 |
| Date of Report | 2016-01-29 |
| Date Mfgr Received | 2016-01-21 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-08-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELOW BERLIN 14513 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION REFERENCE UNIT |
| Generic Name | KERATOMETER, PUPILLOMETER |
| Product Code | HLG |
| Date Received | 2015-08-12 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | NA |
| ID Number | 2.6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELOW BERLIN 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-12 |