BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 14138554 · Received April 18, 2022

    Report

    Report Number
    2023826-2022-01180
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 21, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT: UNK ETHNICITY: UNK. RACE: UNK. EXPLANT DATE: UNK. PMA/510(K): THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). CLAIM #: (B)(4).

    Additional Manufacturer Narrative · 0

    B5: THE LENS WAS EXPLANTED ON (B)(6) 2022 AND REPLACED WITH A SHORTER LENS. THE PROBLEM WAS RESOLVED. THE VAULT IS OK AND NORMAL PIO. CLAIM # (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICH13.2 IMPLANTABLE COLLAMER LENS, +06.00 DIOPTER, IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2022. THE LENS WAS REPORTED AS EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606065 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICH13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention UNK.