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

Model Number X-RUS

Device Problem Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

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 but not received to date.(b)(4).

Event Description

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.

Manufacturer Narrative

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.

• 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: oliver kersting ; rheinstrasse 8; teltow 14513 ; GM 14513 ; 3328311516
• MDR Report Key: 5010292
• MDR Text Key: 24535177
• Report Number: 3010300699-2015-00514
• Device Sequence Number: 1
• Product Code: HLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: X-RUS
• Device Catalogue Number: 8065998240
• Device Lot Number: ASKU
• Other Device ID Number: 2.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• 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