BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 7927072 · Received October 2, 2018

    Report

    Report Number
    2023826-2018-01469
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 6, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 FOR MDR # 2023826-2018-04169 WAS SUBMITTED IN ERROR. THIS INFORMATION WAS MEANT FOR MDR # 2023826-2018-01469 FOR CLAIM# (B)(4). THIS INFORMATION WILL BE RESUBMITTED AS FOLLOW-UP #1 FOR MDR # 2023826-2018-01469. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED WITH A SMALLER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766933 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention