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

Model Number X-RUS

Device Problem Incorrect Measurement (1383)

Patient Problem No Code Available (3191)

Event Date 05/16/2017

Event Type  Injury  

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.(b)(4).

Event Description

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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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).

• Brand Name: VERION REFERENCE UNIT
• Type of Device: KERATOMETER, PUPILLOMETER
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer Contact: nadia bailey ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8176152330
• MDR Report Key: 6637487
• MDR Text Key: 77453651
• Report Number: 3010300699-2017-00012
• Device Sequence Number: 1
• Product Code: HLG
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-RUS
• Device Catalogue Number: 8065998240
• Device Lot Number: ASKU
• Other Device ID Number: 00380659982408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SN60AT 24.5; SN60AT 28.0
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR