MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[34739954]
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. Several attempts were made to obtain further information on the event with no response to date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34739955]
A nurse reported that the surgeon was dissatisfied with the intraocular lens (iol) calculations given by the system software. The patient had three diopters of astigmatism prior to the surgery. Following the iol implant surgery, the patient still had one and a half diopters of residual astigmatism. According to the nurse, the patient had previously undergone lasik surgery, many years ago, and this made it difficult to measure the patient for the iol calculations. Several attempts were made to obtain further information on the event with no response to date.
Patient Sequence No: 1, Text Type: D, B5
[37187218]
Evaluation summary: sample was not returned. Provided documentation has been investigated. Preoperative measurements using verion reference unit assume a regular cornea of the patient? S eye. The provided information of the event described that a surgery was planned and performed for a patient with an irregular cornea due to a previous performed lasik surgery. Under the given conditions a cross check with alternative diagnostic devices/methods is recommended according to the user manual. For post lasik cases specific intraocular lens (iol) calculation methods or formulas should have been used to provide the appropriate iol power. ? Alternate-k? Function is available in case previous lasik was selected as pre-existing condition to calculate the alternate k-readings that should be used for appropriate post lasik iol calculation. No technical root cause could be determined, based on the information provided.
Patient Sequence No: 1, Text Type: N, H10
[38781143]
Evaluation summary: sample was not returned. Provided documentation has been investigated. No technical root cause could be determined, based on the information provided. Preop measurements using the product assume a regular cornea of the patient? S eye. The provided information of the event describes that a surgery was planned and performed for a patient with an irregular cornea due to a previous performed lasik surgery. For post lasik cases specific iol calculation methods or formulas should be used to provide the appropriate iol power. The? Alternate-k? Function is available for these cases. With provided information, it could not be determined, which formula has been used. A malfunction of the device could not be determined. The manufacturer internal reference number is: 2015-133833
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2015-00521 |
| MDR Report Key | 5313354 |
| Date Received | 2015-12-21 |
| Date of Report | 2016-02-23 |
| Date Mfgr Received | 2016-02-09 |
| Date Added to Maude | 2015-12-21 |
| 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 | 2015-12-21 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| ID 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 TELOW BERLIN 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-21 |