BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18704969 · Received February 14, 2024

    Report

    Report Number
    2023826-2024-00390
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    December 9, 2023
    Report Date
    January 22, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311300938
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THERE WAS EXCESSIVE VAULTING, PUPIL BLOCK WITH HIGH IOP, MEDICAL MANAGEMENT PERFORMED AND ON (B)(6) 2024 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    H6 - WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM, VICM5 13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). ELEVATED IOP WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530388 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 N/A 00840311300938

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention UNK.