BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15434301 · Received September 15, 2022

    Report

    Report Number
    2023826-2022-03078
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 30, 2022
    Report Date
    August 24, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542116800
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.50/2.0/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022, THE LENS WAS EXPLANTED DUE TO ELEVATED IOP; PIGMENT DISPERSION; BLURRED VISION; ANGLE CLOSURE WITH ELEVATED IOP. THE PROBLEM WAS RESOLVED. STATUS OF EYE IS "OCCASIONAL CLOUDINESS RIGHT EYE ;MGD." CAUSE IS REPORTED AS PATIENT RELATED FACTOR; DEVICE DID NOT FAIL TO PERFORM AS INTENDED. H6: CLINICAL CODE 4581: PIGMENT DISPERSION. CLAIM #(B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.50/2.0/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO EYE PAIN; ANGLE CLOSURE WITH ELEVATED IOP AND BLURRED VISION. "PAIN IN RIGHT SIDE AFTER IMPLANTATION. PUSHING FORWARD ON IRIS. GLAUCOMA SUSPECT POSSIBLE." CAUSE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223794 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 N/A 00841542116800

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention CARTRIDGE MODEL: SFC-45: LOT# UNK| FOAM TIP PLUNGER (FTP), LOT# UNK| INJECTOR MODEL: MSI-PF, LOT# UNK