BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 9873680 · Received March 24, 2020

    Report

    Report Number
    2023826-2020-00633
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Report Date
    February 28, 2020
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL, SERIAL AND EXPIRATION DATE SHOULD BE REMOVED AS IT IS N/A. DEVICE MANUFACTURER DATE SHOULD BE REMOVED AS IT IS N/A. METHOD CODE: 4110 SHOULD BE REMOVED. RESULT CODE : 213 SHOULD BE REMOVED. WORK ORDER SEARCH INFORMATION SHOULD BE REMOVED. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    H6- WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 1

    (EXPIRATION DATE): UNK, NO SERIAL NUMBER REPORTED. THIS PRODUCT IS NOT MARKETED IN THE US. (DEVICE MANUFACTURING DATE): UNK, NO SERIAL NUMBER REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THERE WAS DIFFICULTY WITH THE LENS. THE REPORTER STATED " I UNDERSTAND IT WAS DUE TO DIFFICULTY INSERTING IT INTO THE EYE." 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
    335362 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1