MAUDE Adverse Event Report: TOPCON MEDICAL SYSTEMS, INC. TOPCON; SYNERGY

Model Number VERSION 3.03

Device Problem Patient Data Problem (3197)

Patient Problem Corneal Touch (1794)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

Status update: investigation (topcon) topcon provided an updated status regarding the ongoing investigation into the misplaced patient exam data record.The final list of exam records impacted was 6.All of the impacted records have been staled (hidden) within synergy so that there is no chance of confusion moving forward.The list of impacted patients was provided to opp.The root cause of the issue (a setting that had been changed in the lenstar) has been corrected (the setting was changed back to its original value) and there is no further risk of misfiled patient records.Opp has been instructed to communicate and device configuration changes to the topcon technical support team so that they can verify the correct functioning of the data harvest process into synergy.

Event Description

A patient's diagnostic report with name and demographics detail ended up in another patient's chart.When the chart was pulled for cataract surgery lens calculations, the wrong report appeared.The report name and demographics were not noticed and the wrong calculations were made to chose an interocular lens for surgery.The issue was noticed when the doctor was trying to figure out why the post-operative results were so unexpected.This could have require a second (unnecessary) operation for this patient to exchange the intraocular lens for the correct one, but did not.

• Brand Name: TOPCON
• Type of Device: SYNERGY
• Manufacturer (Section D): TOPCON MEDICAL SYSTEMS, INC.; 111 bauer dr.; oakland NJ 07436
• Manufacturer (Section G): TOPCON MEDICAL SYSTEMS, INC.; 111 bauer dr.; oakland NJ 07436
• Manufacturer Contact: james lorkowski ; 111 bauer dr.; oakland, NJ 07436 ; 2015995187
• MDR Report Key: 6239180
• MDR Text Key: 64931008
• Report Number: 1000307022-2017-00001
• Device Sequence Number: 1
• Product Code: NFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: VERSION 3.03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LENSTAR
• Patient Outcome(s): Other
• Patient Age: 89 YR