MAUDE Adverse Event Report: NIDEK CO., LTD. US-4000; ULTRASONIC ECHOSCAN

Model Number US 4000

Device Problem Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

As a result of investigation, we did not find any problem by measuring with model eyes.No problem with ultrasonic waveform.The setting value did not cause this issue.It is determined that the cause of this incident is user's operational error.It was set as iol eyes for the measurement before the operation.If it is before the operation, the setting has to be phakic eye.Furthermore, it was measured with "gate on" function while probe was slightly off.This event was occurred at the facility in (b)(6) however same product model was distributed in u.S and we determined this information was reportable.We are here to submit mdr due to the fact that the doctor had to perform re-operation again (removed the lens, and replace with new lens).-.

Event Description

The measured result of axial length is 1mm-2mm longer.The doctor has to perform operation again due to the difference (4d) between the actual and measured result of axial length.

• Brand Name: US-4000
• Type of Device: ULTRASONIC ECHOSCAN
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14 maehama, hiroishi-cho,; gamagori, aichi 44300 38; JA 4430038
• Manufacturer Contact: noriyuki yamaguchi ; 34-14 maehama, hiroishi-cho,; gamagori, aichi 44300-38 ; JA 4430038 ; 533678827
• MDR Report Key: 6685554
• MDR Text Key: 79026832
• Report Number: 8030392-2017-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: US 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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