BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 3971897 · Received July 31, 2014

    Report

    Report Number
    2023826-2014-00589
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC®) WITH TORIC OPTIC (B)(4) - SECONDARY SURGERY; VISUAL DISTURBANCES; NO KNOWN DEVICE PROBLEM. EVALUATION RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE PLATE HAPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON THE PRODUCT. CONCLUSIONS - (NO DEVICE FAILURE): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO PATIENT PREFERENCE AND WAS NOT LENS RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A AA4203TL SILICONE SINGLE PIECE LENS WITH TORIC OPTIC IN THE PATIENT'S LEFT EYE. THE PATIENT DID NOT TOLERATE THE MONOVISION LENS, THE PATIENT DID NOT LIKE IT AND WAS UNHAPPY. THE SURGEON DECIDED TO EXPLANT THE LENS, THE INCISION WAS ENLARGED TO REMOVE THE LENS AND THE LENS WAS REPLACED WITH ANOTHER TORIC LENS; A 16.0 SE/2.0 DIOPTER. NO SUTURE WAS REQUIRED. THE PHYSICIAN STATED THIS INCIDENT WAS NOT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446962 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention INJECTOR MODEL - MSI-PR - LOT NUMBER - UNK| CARTRIDGE MODEL - MTC-60C FP - LOT # - UNK