BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8921550 · Received August 22, 2019

    Report

    Report Number
    2023826-2019-01469
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 29, 2019
    Report Date
    July 31, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: DATE OF EVENT IS UNK. IMPLANT DATE IS (B)(6) 2019. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT ONE OF THE SURGEONS PATIENTS IMPLANTED WITH AN ICL ON (B)(6) 2019, "APPEARED TO HAVE A LOWER THAN EXPECTED VAULT IN EACH EYE." THE SURGEON WILL "MONITOR AND WILL BE IN TOUCH AFTER THE PATIENT'S ONE WEEK VISIT." LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716862 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1