BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8278110 · Received January 25, 2019

    Report

    Report Number
    2023826-2019-00178
    Event Type
    Injury
    Date Received
    January 25, 2019
    Report Date
    December 26, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA THIS IS A DUPLICATE FILE OF MDR # 2023826-2019-00177. PLEASE REFER TO MDR # 2023826-2019-00177 FOR FURTHER DETAILS. 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

    IT WAS REPORTED THAT THE PATIENT CANCELLED THE SURGERY AFTER THE EXPLANTED OD LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71779 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention