BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 11683136 · Received April 17, 2021

    Report

    Report Number
    2023826-2021-01065
    Event Type
    Injury
    Date Received
    April 17, 2021
    Date of Event
    June 29, 2020
    Report Date
    March 18, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATION: THE LENS WAS RETURNED DRY, WITH RESIDUE/DEBRIS IN PRODUCT IN A MICROCRENTRIFUGE VIAL. VISUAL INSPECTION FOUND A DEFORMED, HAPTIC TORN, BENT, DEFORMED, AND STRETCHED OUT LENS. DIMENSIONAL INSPECTION FOUND LENS TO BE WITHIN SPECIFICATIONS. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US DEVICE CODE (B)(4): OFF-LABEL USE (ACD < 3.0MM. CLAIM # (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A 12.6MM, VICMO12.6, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. ON 12 OC(B)(6)T 2020 THE LENS WAS EXPLANTED DUE TO LOW VAULT WITHOUT ROTATION AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTER AS UNKNOWN. PATIENT REFUSED TO CHANGE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580534 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Required Intervention