BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17741439 · Received September 13, 2023

    Report

    Report Number
    2023826-2023-03979
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    January 18, 2023
    Report Date
    August 22, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311308378
    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

    H6: HEALTH IMPACT- CLINICAL CODE: 4581 - PIGMENT DISPERSION. H6: HEALTH EFFECT IMPACT CODE: 4644 - ANTIGLAUCOMA MEDS - COMBIGAN, AZOPT, XALATAN. H6 - WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM # (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.50/+3.0/102 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO PATIENT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE (IOP) AND PIGMENT DISPERSION. PATIENT DEVELOPED CHRONIC INFLAMMATION WITH HIGH IOP. MEDICATION WAS ADMINISTERED - ANTIGLAUCOMA; COMBIGAN; AZOPT; XALATAN. POST-OP, THE ANTERIOR CHAMBER HAD MILD INFLAMMATION WITH PIGMENT CELL. THE PATIENT STILL CONTINUES WITH 2 TYPES OF ANTIGLAUCOMA - TIMOLOL BD AND AZOPT BD. CAUSE OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357483 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.6 NA 00840311308378

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention