BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 11087589 · Received December 29, 2020

    Report

    Report Number
    2023826-2020-03163
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    November 26, 2020
    Report Date
    December 9, 2020
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3 - DEVICE EVALUATION: LENS WAS RETURNED IN MICRO-CENTRIFUGE VIAL, RESIDUE ON PRODUCT. VISUAL INSPECTION FOUND HAPTIC TORN AND WITH RESIDUE ON LENS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    UNK, UNK, UNK. THIS PRODUCT IS NOT MARKETED IN THE US. DEVICE PROBLEM CODE: 1494 - OFF-LABEL USE, ACD<3.0MM. CLAIM# 718286.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6, -18.00/2.5/068 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2020. THE LENS WAS REMOVED AND REPLACED ON 26/NOV/2020 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550967 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention