BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 20346426 · Received October 1, 2024

    Report

    Report Number
    2023826-2024-04559
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    July 22, 2024
    Report Date
    September 11, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311338733
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 - A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ELEVATED IOP AND CEPHALALGIA. PERIPHERAL IRIDOTOMY WAS PERFORMED. THE LENS WAS EXPLANTED DUE TO PAIN. THE CAUSE OF THE EVENT WAS REPORTED AS "OTHER", "NO" THE LENS DID NOT FAIL TO PERFORM AS INTENDED WITH CAUSE DETAILS "DURING THE PATIENT'S PAIN FLARE-UP, PIO WAS MEASURED AND WAS NORMAL". CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    H6 - INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH - NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. 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 ELEVATED IOP. PERIPHERAL IRIDOTOMY WAS PERFORMED. PATIENT IS BETTER. LENS REMAINS IMPLANTED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 4 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY. CAUSE OF EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46067 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICH 12.1 00840311338733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention FOAM TIP PLUNGER, LOT# 1716219| SFC-45, LOT# 1721559