MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[124072419]
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
[124072420]
A physician reported an incorrect display of axis during an intraocular lens (iol) implantation procedure. There was no patient impact. The surgeon used a printed calculation from online iol calculator. The surgery was successfully completed the same day.
Patient Sequence No: 1, Text Type: D, B5
[132425997]
Wrong display of axis during implantation due to a use error. No anomalies found by review of device history record. Product met all specifications when released. Most probable root cause is the user accidentally pressed on the alternative value of axis before pressing start so the axis was altered by the user. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2018-00001 |
| MDR Report Key | 7971018 |
| Date Received | 2018-10-16 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2018-10-16 |
| 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. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| 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 | 0 |
| Brand Name | VERION REFERENCE UNIT |
| Generic Name | KERATOMETER, PUPILLOMETER |
| Product Code | HLG |
| Date Received | 2018-10-16 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| 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 (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-16 |