BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15434626 · Received September 15, 2022

    Report

    Report Number
    2023826-2022-03079
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 23, 2022
    Report Date
    August 24, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542120852
    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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: THE REPORTER INDICATED THAT A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF -14.50/1.0/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2022. ON (B)(6) 2022, THE LENS WAS EXPLANTED DUE ELEVATED IOP; PIGMENT DISPERSION; BLURRED VISION; ANGLE CLOSURE WITH ELEVATED IOP. THE PROBLEM WAS RESOLVED. STATUS OF EYE IS "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 -14.50/1.0/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO EYE PAIN; ANGLE CLOSURE WITH ELEVATED IOP AND GLARE/HALOES. "PAIN IN LEFT SIDE AFTER IMPLANTATION. PUSHING FORWARD ON IRIS. GLAUCOMA SUSPECT POSSIBLE; PHOTOSENSITIVITY. PIGMENTATION." CAUSE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527805 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 N/A 00841542120852

    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.