BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 6391606 · Received March 9, 2017

    Report

    Report Number
    2023826-2017-00353
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    October 7, 2015
    Report Date
    February 7, 2017
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NAME:SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC). DEVICE EVALUATION: LENS WAS RETURNED DRY , IN LENS CASE. VISUAL INSPECTION FOUND A PIECE OF HAPTIC AND OPTIC TORN OFF AND MISSING. CLEAR/ RED RESIDUE WAS OBSERVED ON THE LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    NO SIMILAR COMPLAINTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    AN AA4204VF SILICONE SINGLE PIECE LENS, +22.5 DIOPTER, WAS RETURNED MISSING A PIECE OF THE HAPTIC AND OPTIC. 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
    172934 SEE H10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AG AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1