MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[46163854]
Evaluation summary: the device history records (dhr) for the device was reviewed. The associated device was released based on company acceptance criteria. 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
[46163855]
A surgeon reported that following implantation of toric intraocular lenses (iols), the refractive outcomes have not been as expected. The surgeon explained that in 25 percent of his patients, the clinical outcome has been 90 degrees away from the predicted position calculated by the system. The surgeon believes the equipment may be flawed. The surgeon did not provide a specific number of cases or patients. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[50521772]
Evaluation summary: root cause: most likely identified as use error and additional training was performed. Actions taken: the surgeon mentor program was offered to the reporting surgeon. The sales team has been working closely with him regarding iol calculation and selection for qualifying candidates has been going very well. This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate. This will include completing reviews of complaint class report levels on a monthly basis. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2016-00026 |
| MDR Report Key | 5686335 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-07-26 |
| Date Mfgr Received | 2016-07-01 |
| Device Manufacturer Date | 2014-09-11 |
| Date Added to Maude | 2016-05-27 |
| 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 | 2016-05-27 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| ID Number | 2.6 |
| 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. Other | 2016-05-27 |