MAUDE Adverse Event Report: TOPCON HEALTHCARE SOLUTIONS, INC SYNERGY ODM; OPHTHALMIC IMAGE MANAGEMENT SYSTEM

Model Number	4.06.004.14719
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Codes	Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Synergy odm is a discontinued samd with only 11 instances remaining in the united states.During the initial investigation, topcon support and engineering remoted directly into the customer's environment to attempt reproduction of the issue.The exam in question was printed correctly, and the reported issue could not be reproduced.It was noted that patient "mr" did not have any images stored in synergy and no link between the two patients could be found via a database search.Topcon has made multiple requests to the customer for additional information about the workflow used by the customer so that another attempt can be made to reproduce the issue and identify the cause, but no feedback has been provided to topcon.The customer was also asked why a patient agreed to have a surgery performed if, as found by topcon engineering, there are no images or exam records under the patient's id in synergy, but no response has been provided at this time.
Event or Problem Description
The end user reported that synergy software printed the incorrect patient name (patient mr) in the header of the exam for another patient (la) resulting in two names present on a single page.The end user reported that this resulted in a mis-diagnosis and improper surgery for the patient (mr).The type of surgery performed and information regarding the patient outcome including whether there will be any permanent consequences or whether additional surgery was necessary to correct the patient remains unknown in spite of multiple requests to disclose this information.Topcon healthcare solutions support was unable to reproduce the issue when remoted into the customer's environment.
Additional Manufacturer Narrative
Consultation between a technician and the physician to determine whether any particular workflow contributed to the error proved to be inconclusive.The remaining hypothesis is that an error occurred in the user's browser cache that resulted in this error, but since the cache is not maintained this cannot be verified.The customer impacted by this error will be transitioned to an alternative software solution to prevent any reoccurrence that may be caused by the user environment or user workflow.Corrected data: b1: corrected to "adverse event".B2: corrected to "required intervention to prevent permanent impairment/damage".B5: added new information.H1: corrected to "serious injury".H6: corrected clinical code to 4471, "unspecified eye/vision problem"; corrected impact code to 4629, "device revision or replacement".H10: added new information to narrative.
Event or Problem Description
The patient underwent a corrective surgery to have their bilateral lenses replaced with those of the correct prescription.This corrective surgery occurred the day after the initial incident, and no post-operation issues have been reported since then.

• Brand Name: SYNERGY ODM
• Common Device Name: OPHTHALMIC IMAGE MANAGEMENT SYSTEM
• Manufacturer (Section D): TOPCON HEALTHCARE SOLUTIONS, INC; 111 bauer drive; oakland NJ 07436
• Manufacturer Contact: ian boland ; 111 bauer drive; oakland, NJ 07436 ; 5512704341
• MDR Report Key: 15869003
• Report Number: 3013986459-2022-00001
• Device Sequence Number: 5209563
• Product Code: NFJ
• UDI-Device Identifier: 00852683007018
• UDI-Public: 00852683007018
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4.06.004.14719
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2022
• Supplement Date Received by Manufacturer: 10/30/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 66 KG