BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6429982 · Received March 23, 2017

    Report

    Report Number
    2023826-2017-00475
    Event Type
    Injury
    Date Received
    March 23, 2017
    Report Date
    February 23, 2017
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: THE REPORTER CONFIRMED THAT THE DOCTOR MADE A MISTAKE WHEN WRITING LENS POWER AND PRE-OP K VALUES IN THE OS IN THE OCOS FORM. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: THE REPORTER CONFIRMED THAT THE DOCTOR MADE A MISTAKE WHEN WRITING LENS POWER AND PRE-OP K VALUES IN THE OS IN THE OCOS FORM. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: THE REPORTER CONFIRMED THAT THE DOCTOR MADE A MISTAKE WHEN WRITING LENS POWER AND PRE-OP K VALUES IN THE OS IN THE OCOS FORM. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -17.5/+2/167 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. DOCTOR IS MONITORING THE PATIENT STATUS. AS OF THE DATE OF MDR SUBMISSION, THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209353 ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other