MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-06-13 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[77453651]
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
[77453652]
A surgeon reported a discrepancy between the predicted and actual postoperative refractions following guidance from preoperative measurements. Following cataract surgery with intraocular lens implant the patient reported good near vision but poor distance vision. Additional measurements were taken one day post operatively. The patient underwent an explant followed by implant of a new intraocular lens two days following the original treatment. Two days following the second procedure there was improvement in the post operative refraction. Additional information received, the patient is doing well and the planned outcome was achieved following reimplantation. There are two related reports for this patient. This report addresses the patient's right eye, and another manufacturer report will be filed for the fellow eye.
Patient Sequence No: 1, Text Type: D, B5
[108022128]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[108022253]
No anomalies found by review of device history record. Product met all specifications when released. The measurement module which was used to take the diagnostic measurements provide traffic light indicators to indicate the quality of the image for good measurement results. In this case yellow showed up which recommends to acquire a further image for a better measurement. The user ignored this indication and continued in the process. Several factors could lead to the unexpected results. The image which was used for the diagnostic measurement was indicated to be not optimal, however the user did not recognize this warning and continued with this image. The calculation formula which is used to determine the lens to be implanted was not the recommended formula for these kind of patients (patients with refractive surgery). Also, for these kind of patients which likely might have a non- intact cornea it is mandatory to make a cross check with other diagnostic devices/methods to check for plausibility. No malfunction of the device can be determined, as technical root cause use error was identified. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00012 |
| MDR Report Key | 6637487 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-13 |
| Date of Report | 2017-09-04 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-06-13 |
| 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 | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91058 |
| Manufacturer Phone | 8176152330 |
| 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 | 2017-06-13 |
| 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. Other; 2. Required No Informationntervention | 2017-06-13 |