MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[24535177]
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. Additional information has been requested but not received to date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24535178]
A physician reported deviations up to a maximum of 1. 5 diopter (d9 in the spherical equivalent between the intraocular lens (iol) master and the system. There were 12 patients affected. All of them were treated according to the iol master measurements. There was no patient harm. Additional information has been requested but not received to date.
Patient Sequence No: 1, Text Type: D, B5
[32288624]
Sample returned and investigated. No anomalies found by review of device history record. Product met all specifications when released. Correct setup of fixation led is important for correct measurements as the patient has to look to one reference point during measurements. A deviation of readings will be a result of bad orientation of patients eye if the fixation led is turned off during measurement.. Correct brightness of the led is adjusted during installation procedure. It is likely that after installation the user set the device configuration to the original factory settings. This also changed the adjusted led brightness value to a value below a minimum value to turn the led on. This issue was addressed and measurement module has been replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2015-00514 |
| MDR Report Key | 5010292 |
| Date Received | 2015-08-18 |
| Date of Report | 2015-11-30 |
| Date Mfgr Received | 2015-11-30 |
| Device Manufacturer Date | 2014-02-25 |
| Date Added to Maude | 2015-08-18 |
| 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 | FRAU OLIVER KERSTING |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW 14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | 14513 |
| Manufacturer Phone | 3328311516 |
| 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 | 2015-08-18 |
| Returned To Mfg | 2015-10-30 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| ID Number | 2.6 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-08-18 |