BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2771257 · Received October 3, 2012

    Report

    Report Number
    2023826-2012-00769
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS WITH TORIC (ELASTIC). (B)(4).

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A 25.0 SE/3.5 DIOPTER AA4203TL SILICONE SINGLE PIECE LENS WITH TORIC ON (B)(6) 2012 AND THE PATIENT WAS NOT HAPPY WITH THE VISION OUTCOME. THE DOCTOR OFFERED THE PATIENT OTHER OPTIONS SUCH AS LAZER BUT PATIENT CHOSE TO HAVE THE LENS REPLACED. THE LENS WAS REMOVED, DISCARDED AND REPLACED WITH A 23.0SE/3.5 DIOPTER LENS ON (B)(6) 2012 AND PATIENT WAS THRILLED WITH THE RESULTS. THE REPORTER STATED THE LENS EXCHANGE WAS DUE TO A PATIENT PREFERENCE AND NOT RELATED TO THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention