BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15834977 · Received November 21, 2022

    Report

    Report Number
    2023826-2022-03242
    Event Type
    Injury
    Date Received
    November 21, 2022
    Report Date
    August 25, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNK. WORK ORDER SEARCH FOUND NO SIMILAR COMPLAINTS. CLAIM# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 12.6 MM VICM612.6, -15.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO A PATIENT'S RIGHT EYE (OD) (B)(6) 2021. ON (B)(6) 2021, LVC WAS PERFORMED DUE TO RESIDUAL REFRACTION AND POOR UDVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345642 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK.