MAUDE Adverse Event Report: AL-SCAN; OPTICAL BIOMETER

Model Number AL-SCAN

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Based on the investigation including internal test, the nco was able to duplicate the similar unusual axial length and waveforms by electronic discharge exceeded the criteria.The nco considered external electromagnetic disturbance in abnormal operating conditions possibly may have caused to al-scan which is conformed to international standards for electromagnetic compatibility of medical device and has been verified to operate properly under normal operating condition.In order to prevent the incident in customer site in the united states, nco requested nidek inc.Which is usa subsidiary of nco to alert to this symptom and also recommended that the software should be upgraded with the new version.

Event Description

The manufacturer, nidek co., ltd(abbreviated: nco).Received following information from (b)(6) user through (b)(4) which is (b)(4) subsidiary of nco.On february 1st, 2016, axial lengths were measured before the operation of iols' implantation.The results of measurement were 22.76mm/right eye and 22.61mm/left eye before the operation.After the operation, the axial lengths were re-measured due to poor vision.The axial lengths after operation were 25.50mm/right eye and 25.52mm/left eye at that time.Based on the result of re-measurement, re-operation was carried out, the result is good.When checking the data of the measurement results of french facility, nco confirmed the measurement result of unusual axial length and waveforms at the right end portion of them.

• Brand Name: AL-SCAN
• Type of Device: OPTICAL BIOMETER
• Manufacturer Contact: noriyuki yamaguchi ; 34-14 hiroishi; gamagori, aichi 443-0-038 ; JA 443-0038 ; 33678827
• MDR Report Key: 5751997
• MDR Text Key: 48256161
• Report Number: 3002807715-2016-00021
• 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: foreign,health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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): Required Intervention