MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-15 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[92032383]
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
[92032384]
A surgeon reported a post-operative surprise occurred. Surprise was due to discrepancies of up to 1 millimeter between the system and another company's system. It was reported that if the surgeon would have gone with the other company's system, proper information would have been entered into the system and a miss would not have occurred. Upon follow up, major discrepancy was with the white to white measurement which caused the post-operative surprise.
Patient Sequence No: 1, Text Type: D, B5
[113290829]
No anomalies found by review of device history record. Product met all specifications when released. Sample was replaced. Defective measurement module was returned for investigation. Problem was not reproducible. The root cause was identified as human factor, user handling. The issue can be classified as calibration check related. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00026 |
| MDR Report Key | 7032169 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-15 |
| Date of Report | 2018-02-16 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2017-11-15 |
| 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 | MS. NADIA BAILEY |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW D-14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-14513 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW 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 | 2017-11-15 |
| Returned To Mfg | 2017-11-23 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| ID Number | 00380659982408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-15 |