BEUDAMED
    FDA Adverse Event Summary report: N

    SEE H-10

    MDR report key: 3170308 · Received June 14, 2013

    Report

    Report Number
    2023826-2013-00497
    Date Received
    June 14, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 28, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS TORN INTO TWO PIECES AND THERE WAS CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AA4204VF SILICONE SINGLE PIECE LENS WAS TORN DURING LOADING BUT THE DAMAGE WAS NOT DISCOVERED UNTIL AFTER THE LENS WAS ADVANCING INTO THE EYE. THE LENS WAS REMOVED AND ANOTHER SAME MODEL/SAME DIOPTER LENS WAS IMPLANTED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF A LOADING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271675 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4204VF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR MSI-TR INJECTOR MODEL, LOT NUMBER UNKNOWN| MTC-60FP CARTRIDGE MODEL, LOT NUMBER UNKNOWN