BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 21001725 · Received December 23, 2024

    Report

    Report Number
    2023826-2024-05736
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    November 19, 2024
    Report Date
    November 28, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D2- PRODUCT CODE QBC IN INITIAL MDR IS REPORTED IN ERROR. THIS IS CORRECTED TO QCB. CLAIM# (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) THE PATIENT EXPERIENCED A LOW VAULT WITH ROTATION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949069 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention