MAUDE Adverse Event Report: NIDEK CO., LTD. YC-1800; YAG LASER

Model Number YC-1800

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

As a result of investigation, inspection by engineer from distributor; - as a result of the regular maintenance performed, the data reported is within specification and there is no problem.The energy setting when iol pit occurred: 2.5mj.The focus shift setting when iol pit occurred: 375um (posterior).- the user changed the setting of focus shift.The energy setting was same as the device which user used for 10 years before replacement of the device.Base on this fact we found, it is considered this problem was caused by inadequate user handling because user failed to comply with the operator manual.Our operator's manual specifies the instructions "to avoid excessive reaction, set the energy output of the yag laser beam to the minimum initially, and then increase it until the desired effect can be obtained.Always set the energy output to the minimum after the laser emission.".- we received information that there is no health injury reported, and no medical intervention was required.Nidek final inspection record: - we investigated device history record (dhr) of the unit, and confirmed that it meets all the required quality criteria.- no patient injury was reported, and cause of the problem is user handling.This complaint was reported to nidek distributor in (b)(4).Nidek determined this incident was reportable event as the information has a potential to contribute to a serious injury and the same device marketed in united states.

Event Description

Pit occurred with the surrounding area of iol, however; no pit with center area of iol.Information of the field inspection: the result of the inspection was within product specification and there was no problem.- the yag energy setting when iol pit occurred: 2.5mj.- the focus shift setting when iol pit occurred: 375um (posterior).

• Brand Name: YC-1800
• Type of Device: YAG LASER
• 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
• MDR Report Key: 7243338
• MDR Text Key: 99078338
• Report Number: 8030392-2018-00001
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: YC-1800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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