MAUDE Adverse Event Report: NIDEK CO., LTD AL-SCAN; OPTICAL BIOMETER

Model Number AL-SCAN

Device Problem Insufficient Information (3190)

Patient Problem Visual Disturbances (2140)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

Al-scan ((b)(4)) is currently under investigation.It is scheduled to be returned, and further investigation will be performed.Adverse event can be prevented by following the message "take model eye measurements." appears on the device display prior to its use.It's also stated in the operator's manual (14101-p901-f7).Although this event occurred in a facility in (b)(6), this device is marketed in united states.Nidek determined that it is a reportable event as we became aware of that may have caused or contributed to a serious injury.The distributor reported that the incident (wrong average value calculation of axial length) occurred multiple times, and we are still confirming further details of this event.Follow up report will be submitted when we receive additional information.Al-scan is replaced at the facility, and no recurrence has been reported.In addition, no other facilities have reported same incident (wrong average value calculation of axial length).

Event Description

An adverse event was reported while using al-scan ((b)(4)) which was installed two weeks ago.A physician implanted a wrong diopter iol into patient and reported that he was not satisfied with the result.There is no specific patient information or measurement data.The distributor reported that al-scan ((b)(4)) has been replaced.Al-scan measures axial length for six times, and calculates the average value.(each measured value and average value are displayed on the same screen.) their service engineer performed a field investigation, and observed that average value indicates wrong calculation result as it is not the average value of six values of measurement result.The model eye's measured value should be 28.00 mm, however; the average value measured by this device is sometimes 26.44 mm.

Event Description

Please see the initial mdr submitted on december 7, 2018.

Manufacturer Narrative

The device was returned on january 15, 2019, and we started investigation on the device.We observed a malfunction of the fs motor.In the manufacturing record, no abnormality was found at the time of shipment, and we confirmed that there was no abnormality at the time of installation as well.We determine that there was a cause of reported problem after the installation.We checked the past complaint reports and found no other similar complaints, therefore it is considered this is the single event.In addition, the operator's manual states that users must check the function with a model eye before using the device so that this operation check can make users aware of abnormality by themselves if the device has a malfunction and prevent misdiagnosis to the patient.From the above, we concluded it does not affect on safety and effectiveness.

• Brand Name: AL-SCAN
• Type of Device: OPTICAL BIOMETER
• Manufacturer (Section D): NIDEK CO., LTD; 34-14 maehama, hiroishi; gamagori, aichi 44300 38; JA 4430038
• MDR Report Key: 8140466
• MDR Text Key: 129574731
• Report Number: 8030392-2018-00008
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• PMA/PMN Number: K133132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AL-SCAN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention