BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 16567677 · Received March 17, 2023

    Report

    Report Number
    2023826-2023-00940
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 20, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542121187
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5- THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -16.50/+3.50/093 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED AN EXCESSIVE VAULT, BLURRED VISION, AND RESIDUAL REFRACTIVE ERROR. REPORTEDLY " PATIENT HAS A HIGH VAULT OU BUT THERE HAVE BEEN NO ISSUES WITH IOP. HIS PATIENT ALSO HAS RESIDUAL REFRACTIVE ERROR OD GREATER THAN OS. HOWEVER, THE PATIENT WAS AT UPPER EXTREME OF MYOPIA OD VS OS. HE IS NOT COMPLAINING BUT WANTED TO RECEIVE SOME ADVICE ON FOLLOWING AND OPTIONS FOR THE PATIENT." THE LENS REMAINS IMPLANTED. THE PROBLEM WAS NOT RESOLVED. STATUS OF THE EYE: " BLURRY VISION". THE CAUSE OF THE EVENT IS UNKNOWN. CAUSE DETAILS- "HIGH VAULT". CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    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 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -16.50/+3.5/093 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REPORTED AS EXCESSIVE VAULTING AND THE PATIENT COMPLAINED OF BLURRY VISION. THE LENS REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666044 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.2 NA 00841542121187

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female UNK.