BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 20630851 · Received November 7, 2024

    Report

    Report Number
    2023826-2024-05177
    Event Type
    Injury
    Date Received
    November 7, 2024
    Report Date
    October 21, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311323906
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2 - COMMON DEVICE NAME PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: MTA CORRECTED TO QCB. CLAIM #(B)(4).

    Additional Manufacturer Narrative · 0

    D4 - EXPIRATION DATE: 31-AUG-2023 CORRECTED TO 31-AUG-2026. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    H6 - WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. 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).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION NOT ASSOCIATED WITH LOW VAULT. DUE TO LENS ROTATION NOT ASSOCIATED WITH LOW VAULT, THE LENS WAS REPOSITIONED TWICE. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599330 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO_12.6 N/A 00840311323906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention CARTRIDGE MODEL-UNK, LOT# UNK| INJECTOR MODEL-UNK,LOT-#-UNK| UNK-MODEL-FTP, LOT# UNK