BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 7291078 · Received February 22, 2018

    Report

    Report Number
    2023826-2018-00263
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 22, 2018
    Report Date
    January 24, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    UDI-DI
    00841542101998
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS RETURNED IN LIQUID, IN A LENS CASE/VIAL. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO THE LENS. NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: LENS WAS NEVER IMPLANTED: DATE IS N/A. LENS WAS NEVER IMPLANTED: DATE IS N/A. CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT DURING IMPLANTATION OF A CQ2015A , +20.5 DIOPTER, COLLAMER LENS, THE CARTRIDGE SPLIT OPEN AND THE LENS STARTED COMING OUT FROM THE SIDE OF THE CARTRIDGE. THERE WAS NO PATIENT INJURY AND THE BACK UP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS DUE TO A LOADING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133523 SEE H10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A NA 00841542101998

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR