BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 12606079 · Received October 11, 2021

    Report

    Report Number
    2023826-2021-03851
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    September 10, 2021
    Report Date
    September 20, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT: UNK. ETHNICITY: UNK. RACE: UNK. PMA/510K: THIS PRODUCT IS NOT MARKETED IN THE US. WORK ORDER SEARCH: NO [OR#] SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM#: (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5 13.2, -12.00 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO ELEVATED IOP(23MMHG) WITHOUT PUPIL BLOCK(ASSESSED ON (B)(6) 2021) AND ANGLE CLOSURE (ASSESED ON (B)(6) 2021), AND EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM.CAUSE OF THE EVENT IS REPORTED AS UNKNOWN, ANGLE CLOSURE.REPORTEDLY, CORNEA AND LENS OK. PIO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502270 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention