BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15009494 · Received July 13, 2022

    Report

    Report Number
    2023826-2022-02286
    Event Type
    Injury
    Date Received
    July 13, 2022
    Report Date
    July 13, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2; -13.0/+1.0/107 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. IT WAS REPORTED THAT THE WRONG LENS WAS IMPLANTED DUE TO THE CUSTOMER ORDERED THE WRONG LENS REGARDING THE SEQ AND LENS. THE PATIENT EXPERIENCED NO ADVERSE EVENTS. ON (B)(6) 2022 THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS BUT DIFFERENT POWER LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469192 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention CARTRIDGE MODEL-SFC-45, LOT#-UNK| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK| INJECTOR MODEL-MSI-PF, LOT#-UNK