BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPCON

    MDR report key: 9510717 · Received December 23, 2019

    Report

    Report Number
    3007913988-2019-00001
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Report Date
    December 23, 2019
    Manufacturer
    VISIA IMAGING SRL
    Product Code
    HJO
    PMA / PMN Number
    K160327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISIA IMAGING IS CONDUCTING AN INVESTIGATION ON THE ROOT CAUSE OF THIS MISMATCH OF IOL CONSTANT ON THE PRINTOUT. FOR THE MOMENT, WE ONLY HAVE A REPORT FOR ONE PRINTOUT, WITH ONE UNEXPECTED IOL CONSTANT (WITH THE CORRECT CALCULATION BASED ON THIS CONSTANT) ALTHOUGH VISIA IMAGING MADE SEVERAL ATTEMPTS, BY PHONE AND EMAIL TO INVESTIGATE PROMPTLY THE CONDITION OF THIS DEVICE, THE DOCTOR'S OFFICE COULD NOT MAKE THE INSTRUMENT AVAILABLE YET FOR DETAILED INVESTIGATION, AND AT THIS MOMENT IN TIME THE DOCTOR'S OFFICE HAS POSTPONED THE DEVICE-INVESTIGATION TO THE END OF DECEMBER 2019. AS A CONSEQUENCE, WE CURRENTLY CANNOT ASSUME THE REASONS FOR THIS UNEXPECTED LENS CONSTANT ON THE PRINTOUT. TAKING INTO ACCOUNT THAT FOR THIS TYPE OF DEVICE, THE DOCTOR WILL NOT RELY WITH HIS DECISION ON ONLY THE RESULT OF ONE DEVICE, AND TAKING INTO ACCOUNT THAT HE WILL ALWAYS CONSULT SEVERAL OTHER SOURCES, THE PATIENT'S SAFETY IS NOT AT RISK. AT THE AVAILABILITY OF THE DEVICE FURTHER INVESTIGATION WILL BE PERFORMED. COMPLAINTS WILL BE MONITORED IN THE FUTURE TO DETERMINE IF THIS IS A TREND AND NOT AN ISOLATED OCCURRENCE.

    Description of Event or Problem · 1

    A SURGEON HAS REPORTED A PROBLEM WITH THE PRINTOUT REPORT OF THE ALADDIN DEVICE (REFER TO MW5091263). TOGETHER WITH THE CORRECTLY CALCULATED IOL- RESULT OF THE INVESTIGATED EYE ON THE PRINTOUT, THE DOCTOR ALSO MADE THE OBSERVATION THAT FOR THE OTHER EYE ONE OF IOL S HAD A CONSTANT THAT WAS NOT EXPECTED FOR THAT LENS. BUT, THE IOL CALCULATION IN ALL CASES WAS CORRECT FOR THE INDICATED LENS CONSTANTS. ALTHOUGH THE DOCTOR MADE THIS OBSERVATION OF A MISMATCH OF IOL CONSTANT, THERE WAS NO EFFECT ON THE PATIENT, BECAUSE THE OTHER EYE WITH CORRECTLY CALCULATED IOL WAS USED FOR SURGERY. AS A RESULT THERE WAS NO ADVERSE EVENT. WE HAVE DETERMINED THAT THIS EVENT IS NOT A REPORTABLE ADVERSE EVENT UNDER US REGULATION 21 CFR PART 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308899 TOPCON ALADDIN HW3.0 HJO VISIA IMAGING SRL

    Patients

    Seq Age Sex Outcome Treatment
    1