MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION REFERENCE UNIT; KERATOMETER, PUPILLOMETER

Model Number X-RUS

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

An ophthalmic surgeon reported that there was an issue in the measurements repeatedly.Patients' and employees' measurements could not be repeated.There were differences from 1 to 1.5 d.The patients' measurements were compared with a different device and the measurements were the same as the previous ones.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the device has not been returned, however data collection of the device was performed and analyzed by clinical application specialists.No anomalies found by review of device history record.Product met all specifications when released.Data of (b)(4) measurements were provided and analyzed.These showed that only (b)(4) measurements could be compared against the previous software version, all others did not provide green traffic light and therefore were not recommended to be used.The difference in measurements of sw 2.5.0 and 2.6 differs by 0,2 - 0,5 d which is within accepted limits.Comparing preoperative measurements with postoperative measurements inherently differ by nature of the surgery and its healing process.No technical root cause could be determined.

Manufacturer Narrative

The clock start date on the mdr was originally reported as (b)(6) 2015.The correct date should have been (b)(6) 2015.

• Brand Name: VERION REFERENCE UNIT
• Type of Device: KERATOMETER, PUPILLOMETER
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4995222
• MDR Text Key: 24137510
• Report Number: 3010300699-2015-00513
• Device Sequence Number: 1
• Product Code: HLG
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-RUS
• Device Catalogue Number: 8065998240
• Other Device ID Number: 2.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other