MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-04-27 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[43761913]
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. The device history records (dhr) for the device was reviewed. The associated device was released based on company acceptance criteria. Additional information has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43761914]
A surgeon reported incorrect intraocular lens implanted in a patient's right eye. This was due to misreading the calculation sheet of the device. The lens was explanted at a later date and correct lens inserted. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[45996832]
The investigation is completed. Surgical printout of reported case shows correct lens. The root cause is surgical printout misinterpreted by customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2016-00019 |
| MDR Report Key | 5611115 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-27 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-03-31 |
| Date Mfgr Received | 2016-05-04 |
| Device Manufacturer Date | 2015-05-21 |
| Date Added to Maude | 2016-04-27 |
| 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 |
| 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 | 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 | 2016-04-27 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| ID Number | 00380659982408 |
| 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 | 1. Required No Informationntervention | 2016-04-27 |