BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 6389631 · Received March 8, 2017

    Report

    Report Number
    2023826-2017-00348
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 8, 2017
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00841542103411
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: LENS WAS RETURNED STUCK INSIDE CARTRIDGE. CARTRIDGE WAS RETURNED TAPED TO LAF CARD. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE DEVICE, WHITE/GREY DRY RESIDUE WAS OBSERVED ON CARTRIDGE, AND A STUCK LENS. (B)(4). WORK ORDER SEARCH: NO SIMILAR COMPLAINTS WERE REPORTED FOR UNITS WITHIN SAME LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING. THE REPORTER INDICATED THAT THERE WAS NO PATIENT INJURY AND THE EVENT WAS NOT DEVICE RELATED BUT THE EXACT CAUSE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169778 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA 00841542103411

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention