BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALADDIN HW3.0

    MDR report key: 17315863 · Received July 13, 2023

    Report

    Report Number
    3007913988-2023-00001
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 8, 2023
    Report Date
    August 4, 2023
    Manufacturer
    VISIA IMAGING SRL
    Product Code
    HJO
    PMA / PMN Number
    K160327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE DATE OF 11 JULY WE RECEIVED FURTHER PRINTOUT FROM THE CUSTOMER, WE REVIEWED FURTHER THE LOG FILES AND WE UNDERSTOOD THAT IN A SPECIFIC RARE AND UNUSUAL WORKFLOW SEQUENCE, THE SOFTWARE PERFORMED AS DESCRIBED. BOTH DEVICE MEASUREMENT AND IOL CALCULATION WERE PERFORMED PROPERLY, BUT IN THIS SPECIFIC WORKFLOW SEQUENCE THE "A" CONSTANT WERE NOT INCLUDED IN CALCULATION, LEADING TO THE SUGGESTION OF A SUB-OPTIMAL IOL. THIS MALFUNCTION WILL RECUR ONLY WHEN THE CUSTOMER PERFORM A IOL CALCULATION USING ONE OF THE FORMULAS IN "BARRETT" PANEL, THEN HE SWITCH TO "IOL CALCULATION" PANEL, CHANGE THE SURGEON PRESET, SWITCH AGAIN IN "BARRETT" PANEL AND SWITCH THE PREVIOUSLY CALCULATED LENS.ANYWAY, THIS IS CLEARLY SHOWED BY THE ABSENCE OF "A" CONSTANT IN THE DISPLAYED RESULT BOTH IN THE SW INTERFACE AND IN THE PRINTED REPORT, SO THIS SITUATION CAN BE EASILY DETECTED BY THE SURGEON. WE ESTIMATED THE PROBABILITY OF THIS OCCURRENCE IS LESS THAN 1/10.000.000, WITHIN THE RANGE PREVIOUSLY ESTIMATED IN THE DEVICE RISK ASSESSMENT FOR THIS HAZARD. ACCORDING TO THE LATEST INFORMATION WE RECEIVED, NO FURTHER SURGERY OR TREATMENT HAS BEEN PLANNED FOR THE PATIENT.

    Additional Manufacturer Narrative · 0

    WE ARE NOT ABLE TO REPRODUCE THE DESCRIBED EVENT. AS STATED IN THE DISCLAIMER SHOWED BY THE SW AND REPORTED IN THE USER MANUAL, USERS SHOULD NOT RELY SOLELY ON CALCULATIONS MADE USING THE ALADDIN HW3.0 IN MAKING DECISIONS REGARDING IMPLANTATION OF INTRAOCULAR LENSES OR OTHER THERAPEUTIC PROCEDURES BUT SHOULD RELY ON THEIR OWN EXPERTISE AND JUDGEMENT.

    Description of Event or Problem · 0

    CUSTOMER NARRATIVE: THE DOCTOR TOLD ABOUT A BAD SURGICAL OUTCOME, INCLUDING IMPLANTING IN AN IOL THAT WAS OFF BY 1.5D FROM INTENDED. THE TARGET REFRACTION WAS -1.5D (MONOVISION INTENDED PER DR) AND THE PATIENT ENDED UP AT 0D, WHICH THE PATIENT WAS UPSET ABOUT. THE DOCTOR SAID THAT SHE HAD USED THE LENS POWER THAT SHE DID BASED UPON THE RECOMMENDATION FROM THE ALADDIN. SURGERY DONE IN THE PATIENT'S RIGHT EYE (OD). THE DOCTOR REPORTS THAT THE DEVICE PASSED AND CONTINUES TO PASS CALIBRATION.

    Description of Event or Problem · 0

    CUSTOMER NARRATIVE: THE DOCTOR TOLD ABOUT A BAD SURGICAL OUTCOME, INCLUDING IMPLANTING IN AN IOL THAT WAS OFF BY 1.5D FROM INTENDED. THE TARGET REFRACTION WAS -1.5D (MONOVISION INTENDED PER DR) AND THE PATIENT ENDED UP AT 0D, WHICH THE PATIENT WAS UPSET ABOUT. THE DOCTOR SAID THAT SHE HAD USED THE LENS POWER THAT SHE DID BASED UPON THE RECOMMENDATION FROM THE ALADDIN. SURGERY DONE IN THE PATIENT'S RIGHT EYE (OD). THE DOCTOR REPORTS THAT THE DEVICE PASSED AND CONTINUES TO PASS CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247662 ALADDIN HW3.0 BIOMETER HJO VISIA IMAGING SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other