BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 9417003 · Received December 5, 2019

    Report

    Report Number
    2023826-2019-02307
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    July 5, 2018
    Report Date
    November 11, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED TO: THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. BLURRED VISION, ELEVATED IOP, AND CONSTANT VERTICAL BLACK LINE WERE OBSERVED. REPORTEDLY "BLURRING OF VISION SINCE SURGERY ((B)(6) 2018) AND A CONSTANT VERTICAL BLACK LINE WAS SEEN." THE ELEVATED IOP 'WAS BOUGHT UNDER CONTROL WITH DROPS' AND 'PBI WAS ALSO DONE.' THE LENS WAS REPOSITIONED ON (B)(6) 2019, BUT THE LINE REMAINED AND BECAME HORIZONTAL. THE LENS REMAINS IMPLANTED WITH PLANNED EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. PATIENT CODE 3191 - SECONDARY INTERVENTION: MEDICAL INTERVENTION (DROPS), LENS REPOSITIONING, PBI. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    WEIGHT: UNK. ETHNICITY: UNK. RACE: UNK. THIS PRODUCT IS NOT MARKETED IN THE US. (B)(4). WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. BLURRED VISION AND CONSTANT VERTICAL BLACK LINE WAS OBSERVED. LENS REMAINS IMPLANTED. REPORTEDLY "BLURRING OF VISION SINCE SURGERY ((B)(6) 2018) AND A CONSTANT VERTICAL BLACK ONE WAS SEEN." PER REPORTER ON (B)(6) 2019, DOCTOR HAS REQUESTED A REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211722 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention UNK.