BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8274015 · Received January 24, 2019

    Report

    Report Number
    2023826-2019-00173
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    January 11, 2018
    Report Date
    December 26, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: CORRECTED TO: PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: QCB ADDITIONAL DATA: DEVICE EVALUATION: LENS WAS RETURNED DRY, IN A MICRO-CENTRIFUGE VIAL. THERE WAS CLEAR SURGICAL RESIDUE ON PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS AND PRESENCE OF RESIDUE ON LENS SURFACE. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM, VTICM5_12.1, -12.00/2.0/082 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO OBSERVATION OF LOW VAULT WITH ROTATION. THIS EXCHANGE RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67992 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention