BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6060685 · Received October 27, 2016

    Report

    Report Number
    2023826-2016-01533
    Event Type
    Injury
    Date Received
    October 27, 2016
    Report Date
    October 12, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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). LENS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT THE SURGEON INSERTED A 13.2 VTICMO13.2 IMPLANTABLE COLLAMER LENS, -13.00/+3.0/092 DIOPTER, IN THE PATIENT'S RIGHT EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING OF THE LENS, A SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, BLURRED VISION, UNREACTIVE PUPIL, AND IRIS PUSHED TOWARDS THE CORNEA. THE LENS WAS REPOSITIONED AND THE ANTERIOR CHAMBER WAS WASHED AND IRRIGATED/EVACUATED OF REMAINING VISCO/FLUIDS. (B)(4). CORRECTED DATA: EXPLANTED DATE: N/A. (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON INSERTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -13.00/+3.0/092 DIOPTER, IN THE PATIENT'S RIGHT EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING OF THE LENS, A SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, BLURRED VISION, AND UNREACTIVE PUPIL. THE LENS WAS REPOSITIONED, AND THE ANTERIOR CHAMBER WAS WASHED AND IRRIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711778 ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention