MAUDE Adverse Event Report: NIDEK CO., LTD. EC-5000 QUEST; NIDEK EXCIMER LASER QUEST

Model Number EC-5000 QUEST

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problem Eye Injury (1845)

Event Date 03/04/2016

Event Type  No Answer Provided  

Manufacturer Narrative

In regards to the patient injury complaint, nidek clinical specialist and customer service manager contacted facility on (b)(4) 2016 to gather additional information.A representative ((b)(6)) from (b)(6) office called back and informed that doctor is aware of the issue occurred with this patient.He also assured that the problem is not related to "nidek's product".However the problem is related to the keratome (zeimer femto laser) used by sharpe vision.As per the information from nidek field service representative, dr (b)(6) uses ziemer femto laser.After the investigation nidek would like to confirm that the patient injury occurred is due to the keratome (zeimer femto laser) and not the nidek inc.'s ec-5000 quest.Since the device in question is not manufactured by nidek inc., additional information regarding device evaluation is not available.Additionally, other information related to the status of the patient injury, any medical or surgical intervention was required or not was not provided by the patient and/or the user facility at the time.

Event Description

Nidek inc.Customer service representative (rep.) received a call on (b)(4) 2016 from gentlemen by the name of (b)(6) complaining that his girlfriend received lasik from dr (b)(6) on (b)(6) 2016.Patient reported that during surgery, she had a major damage on one eye.As per the reporter, dr (b)(6) informed that the laser made a "j cut" causing damage to the patient's eye (eye lid).However, nidek customer service rep.Informed (b)(6) that nidek laser does not perform the cut and that there is a different piece of equipment that does that portion.(b)(6) also mentioned that on (b)(6) 2016 patient received prk from dr (b)(6) on the other eye.

• Brand Name: EC-5000 QUEST
• Type of Device: NIDEK EXCIMER LASER QUEST
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer (Section G): NIDEK CO., LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer Contact: preeti gandhi ; 47651 westinghouse drive; fremont, CA 94539-7474 ; 5103537785
• MDR Report Key: 5618524
• MDR Text Key: 43982972
• Report Number: 3002807715-2016-00016
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 04987669100028
• UDI-Public: (01)04987669100028
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-5000 QUEST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1