BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 17172885 · Received June 21, 2023

    Report

    Report Number
    3005744933-2023-00001
    Event Type
    Death
    Date Received
    June 21, 2023
    Date of Event
    February 17, 2023
    Report Date
    May 6, 2023
    Manufacturer
    OPTOS INC
    Product Code
    MYC
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OPTOS HAS TAKEN THE DECISION TO REPORT OUT OF AN ABUNDANCE OF CAUTION DUE TO THE CIRCUMSTANCES SURROUNDING THIS EVENT AND THE LACK OF INFORMATION OPTOS HAS BEEN ABLE TO OBTAIN IN ORDER TO PERFORM A FULL INVESTIGATION. THE INFORMATION CURRENTLY AVAILABLE TO OPTOS THROUGH FDA MEDWATCH FORM 3500, PROVIDE NONE OF THE DETAILS REQUIRED TO CARRY OUT A THOROUGH INVESTIGATION. INFORMATION RELATING TO ANY PRE-EXISTING OPHTHALMIC CONDITIONS, KNOW ALLERGIES OR ANY DETAILS ABOUT WHAT (IF ANY) MEDICATION THE PATIENT WAS TAKING, IF ANY MEDICAL INTERVENTION WAS PROVIDED, THE TIME BETWEEN; THE OPTOMAP PROCEDURE, THE ONSET OF THE SEIZURE, AND UNFORTUNATE DEATH OF THE PATIENT. REPORTED THROUGH FDA MAUDE MDR REPORT KEY 16993736 WAS ADDITIONAL INFORMATION REGARDING TREATMENT, THAT WAS NOT PROVIDED ON MEDWATCH REPORT MW5117780, THAT THE PATIENT WAS TAKING THE FOLLOWING MEDICATIONS FISH OIL ; CBD; CERTIZINE HCL ; FENOFIBRATE ; GLUTATHIONE CELL DEFENSE ; HLC MINDLINX; IBUPROFEN ; L-THEANINE DETOX SUPPORT; LITHIUM CARBONATE ; MIRTAZAPINE ; NYSTATIN ; PENTASA; RISPERIDONE ; THERA-M SENNA-PLUS; THERAPEUTIC FACTOR 6 STEPS OPTOS, HAS TAKEN. OPTOS HAS CONTACTED THE FDA, IN AN ATTEMPT TO ACQUIRE ANY ADDITIONAL DETAILS RELATING TO THE EVENT BUT WAS INFORMED THAT NO FURTHER INFORMATION COULD BE GIVEN. OPTOS IS ALSO NOT ABLE TO CONTACT THE REPORTER AS THEY HAVE REQUESTED THE INFORMATION REMAIN CONFIDENTIAL. OPTOS INITIAL AND ONLY AWARENESS OF THIS EVENT WAS THROUGH AN EMAIL RECEIVED ON 26/MAY/2023. SINCE FORM MW5117780 INDICATES THE DATE OF THE EVENT IS (B)(6) 2023, OPTOS UNDERTOOK TO EXAMINE RECORDS OF CUSTOMER CALLS COLLECTED IN MS CRM, OUR COMPLAINT DATABASE, FROM THE TIME LEADING UP TO OR AROUND THE TIME OF THE EVENT AND THE DATE THE REPORT WAS RECEIVED BY OPTOS FROM MEDWATCH. THIS WAS DONE TO IDENTIFY WHETHER THERE HAD BEEN ANY REPORTS MADE THAT WERE NOT REPORTED THROUGH OPTOS ESTABLISHED POTENTIAL HEALTH INCIDENT PROCESS (PHI). THE ANALYSIS USED A SET OF KEY WORDS, INCLUDING THOSE SIMILAR TO THE WORDING STATED IN THE REPORT, LOOKING FOR A MATCH TO WORDS RECORDED OF THE CUSTOMERS COMPLAINT. THIS WAS DONE TO IDENTIFY ANY CASES THAT CONTAINED THESE KEY WORDS SO THAT THESE RECORDS COULD BE FURTHER EXAMINED TO DETERMINE IF THAT COMPLAINT CALL WAS RELATED TO THE EVENT REPORTED. THE ANALYSIS CONCLUDED THAT THERE WERE NO COMPLAINT CALLS IDENTIFIED THAT WERE RELATED TO THIS EVENT. ADDITIONALLY, OPTOS CARRIED OUT AN ON-LINE SEARCH TO LEARN WAS ANY INFORMATION WHICH HAD BEEN REPORTED. THIS SEARCH YIELDED NO RESULTS WHICH COULD PROVIDE ADDITIONAL INFORMATION DIRECTLY RELATED TO THIS EVENT. THE INVESTIGATION AND EVALUATION INTO THE CAUSE OF THE EVENT DESCRIBED IN THE MEDWATCH FORM, HAS CONCLUDED THAT THE INFORMATION AVAILABLE IS INSUFFICIENT. NECESSARY INFORMATION SUCH AS CUSTOMER SITE WHERE THE EVENT TOOK PLACE, THE DEVICE TYPE/SERIAL NUMBER, THE TIME AND ACTIONS BETWEEN THE OPTOMAP PROCEDURE AND THE ONSET OF SEIZURE AND SUBSEQUENT DEATH, WERE NOT MADE AVAILABLE TO OPTOS. ALL OPTOS UWF DEVICES ARE INTENDED FOR PROFESSIONAL USE ONLY. USERS MUST HAVE KNOWLEDGE OF BASIC EYE ANATOMY AND EXPERIENCE IN OPERATING OPHTHALMIC IMAGING AND DIAGNOSTIC DEVICES. ALL OPTOS DEVICES ARE SUPPLIED TO THE END USER WITH INSTRUCTIONS FOR USE (IFUS). WHICH CONTAIN WARNINGS AND CAUTIONS. OPTOS BELIEVES THAT THE INFORMATION PROVIDED IN THE INSTRUCTIONS FOR USE, WHICH ARE SUPPLIED TO THE END USER, WHICH INCLUDE WARNING AND CAUTIONS REGARDING INDIVIDUALS WITH A SENSITIVITY TO FLASHES OF LIGHT, ALONG WITH THE TRAINING OPTOS PROVIDES TO THE END USER, WHICH HIGHLIGHT THIS WARNING, ARE SUFFICIENT TO PROVIDE AWARENESS TO THE CLINICIAN OF THE POTENTIAL NEGATIVE OUTCOME. THIS INFORMATION ALLOWS THE CLINICIAN TO DETERMINE, ALONG WITH THEIR PATIENT, IF THE BENEFIT OF HAVING AN OPTOMAP PROCEDURE OUTWEIGHS THE RISKS. OPTOS HAS TAKEN THE DECISION TO REPORT OUT OF AN ABUNDANCE OF CAUTION DUE TO THE CIRCUMSTANCES SURROUNDING THIS EVENT AND THE LACK OF INFORMATION OPTOS HAS BEEN ABLE TO OBTAIN IN ORDER TO PERFORM A FULL INVESTIGATION, OPTOS HAS EXHAUSTED ALL POSSIBLE AVENUES TO TRY AND IDENTIFY THE SITE OR DEVICE, AND CONFIRM WHAT OTHER CONTRIBUTORY FACTORS SHOULD BE TAKEN INTO CONSIDERATION. NOTES REGARDING THE ENTRY MADE IN SECTION D2 FOR PRODUCT CODE. ALTHOUGH OPTOS WAS NOT PROVIDED SPECIFIC INFORMATION INDICATING WHICH DEVICE WAS USED TO IMAGE THE PATIENT, IN ORDER TO COMPLETE THE FORM FOR SUBMISSION OPTOS HAS SELECTED THIS CODE AS IT COVERS ALL OPTOS DEVICES.

    Description of Event or Problem · 0

    OPTOS RECEIVED AN EMAIL ON 26/MAY/2023 WHICH CONTAINED MEDWATCH REPORT MW5117780 REGARDING THIS MATTER. THE ONLY INFORMATION REGARDING THE EVENT OR PROBLEM, MADE AVAILABLE TO OPTOS THROUGH THE MEDWATCH REPORT WAS THAT AN AUTISTIC SON WAS BROUGHT IN FOR AN ANNUAL EYE EXAM ON (B)(6) 2023. THIS IS THE FIRST TIME THE NIKON OPHTHALMIC LASER SCANNER WAS USED TO EXAMINE HIM. HE HAD NO HISTORY OF SEIZURES BUT BEGAN TO HAVE FOCAL SEIZURES CULMINATING IN HIS DEATH ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213838 UNKNOWN MYC OPTOS INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death