BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15065196 · Received July 20, 2022

    Report

    Report Number
    2023826-2022-02186
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    November 18, 2021
    Report Date
    June 21, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT, RACE, ETHNICITY: UNK. CLAIM#: (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.7MM VTICMO13.7 IMPLANTABLE COLLAMER LENS OF -14.5/1.5/103 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE EXCHANGE RESOLVED THE PROBLEM. CAUSE IS REPORTED AS UNKNOWN. REPORTEDLY, "1. THE NEW LENS WAS IMPLANTED VERTICALLY. 2. THE REASONS FOR DIFFERENCE OF REFRACTIVE POWER BETWEEN TWO LENS ARE AS FOLLOWS: 1. SEQ WERE ALMOST THE SAME; 2. AT FIRST, THE PATIENT COULDN'T WAIT FOR THE SURGERY WHILE A TICL WITH CYLINDER OF 1.50D WAS IN STOCK. THE CYLINDER POWER OF THE NEW LENS WAS THE SAME AS MANIFEST REFRACTIVE RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828790 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention CARTRIDGE MODEL: LOT# UNK| FOAM TIP PLUNGER - LOT# UNK| INJECTOR MODEL: MSI-PF - LOT# UNK