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

Model Number X-RUS

Device Problem Incorrect Measurement (1383)

Patient Problem Blurred Vision (2137)

Event Date 09/05/2019

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.The device history records (dhr) for the device were reviewed.The associated device was released based on company's acceptance criteria.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported that intraocular lens (iol) measurements were taken months prior to iol implantation.Calculations called for a non-toric iol which the doctor implanted.Following the placement in the operating room of the iol, there was an error is sphere calculation of more than 2.5 diopters and patient could not adapt.An explant of the iol was performed approximately one week later.Additional information was received.The implant itself is not suspected.Implant was cut out with scissors and not kept.Implant was cut in intracameral for explant.Calculations for the implant were taken on the day that the diagnostic machine was installed by company representative.Myopia resulted post operation.Intraocular lens was explanted and the patient was implanted with a monfocal lens.Blurry vision was initially observed without correction.

Manufacturer Narrative

The event lead to a serious deterioration in state of health (implantation of a wrong iol following an explantation) due to a device malfunction.There is a risk to the patient.It could be concluded that the device malfunction is not a systematic issue but an issue which was caused by a double fault condition.The wrong current device calibration is caused by a double fault condition: 1.During reprocessing, the factory default calibration was deleted.2.During software update to 3.1, calibration check was skipped or error message was ignored.This could be determined within the non-conformance investigation.The unit was replaced on site and the logfiles were analyzed.As the procedure was not followed as it is described, this issue must be determined as human error.However, in order to eliminate the likelyhood of a human error, the following contributing factors were identified: 1.A lack of training (understanding the importance of the calibration check) and (corrections).2.Inadequate procedure (check points could be pointed out more clearly).3.Service test procedure does not require a routine calibration check (in order to increase detectability).The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Device calibration values did not match factory settings anymore from when the device left production.The current values correspond to the latest software release default values.During software update, a mandatory calibration check was not performed or error messages were ignored which would have identified the missing device specific factory values.Root cause was determined as an combination of two failure modes - one during reprocessing and one during software update (maintenance in warehouse) of measurement module.The manufacturer internal reference number is: (b)(4).

• Brand Name: VERION REFERENCE UNIT
• Type of Device: KERATOMETER, PUPILLOMETER
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• MDR Report Key: 9144912
• MDR Text Key: 163122356
• Report Number: 3010300699-2019-00009
• Device Sequence Number: 1
• Product Code: HLG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 65