BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS-NI2

    MDR report key: 11683554 · Received April 18, 2021

    Report

    Report Number
    2023826-2021-01071
    Event Type
    Malfunction
    Date Received
    April 18, 2021
    Date of Event
    March 6, 2021
    Report Date
    March 19, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3- DEVICE EVALUATION: NO ABNORMAL SHAPE WAS FOUND ON THE ROD OR NOZZLE PART. THE AMOUNT OF VISCOELASTIC MATERIAL INJECTED WAS INFERRED TO BE SUFFICIENT BASED ON THE MARK OF VISCOELASTIC MATERIAL FILLED. THE LENS WAS CUT AND BOTH LOOPS OF LENS WERE FOUND DEFORMED. H6- DEVICE HISTORY RECORD (OHR) REVIEW: THE SERIAL WAS CERTIFIED BY COC ISSUED BY MANUFACTURER WITHOUT ANY IRREGULARITIES. THERE WAS NO IRREGULARITY FOUND AT VISUAL INCOMING INSPECTION CLAIM # (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    OPTICAL PART ROTATION AT LENS INSERT OF A KS-NI2 AQ310AIN, 14.0 DIOPTER PRELOADED INJECTOR WAS REPORTED. THE ONCE IMPLANTED IOL WAS CUT AND REMOVED BECAUSE THE POSITION OF THE IMPLANTED LENS WAS NOT AS EXPECTED AND HARD TO REPOSITION THE IOL. BACK UP LENS WAS USED AND THE SURGEY WAS COMPLETED SUCCESSFULLY. THE REPORTER STATED "AS THE LENS SHOULD BE ONCE IMPLANTED BUT SOON REMOVED FROM THE PATIENT, THERE WAS "SURGERY TOOK LONGER THAN USUAL" BUT NO PATIENT INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580885 KS-NI2 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY KS-NI2 AQ310AIN 14.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown