BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8275003 · Received January 24, 2019

    Report

    Report Number
    2023826-2019-00171
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    December 16, 2018
    Report Date
    December 27, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THIS IS A DUPLICATE FILE OF MDR # 2023826-2019-00154. PLEASE REFER TO MDR # 2023826-2019-00154 FOR FURTHER DETAILS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM,VTICMO12.6, -11.00/1.5/098 (SPHERE/CYLINDER/AXIS) , IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS EXCHANGE RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69431 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention