BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2884696 · Received December 24, 2012

    Report

    Report Number
    2023826-2012-01004
    Event Type
    Malfunction
    Date Received
    December 24, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING, STERILIZATION OR PACKAGING PROCESSES OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE DEVICE HISTORY RECORD REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO: LENS NOT RETURNED. METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2015A ASPHERIC SILICONE THREE PIECE LENS AND THE SURGEON NOTED THE LENS WAS CRACKED. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE SURGEON FELT THE LENS WAS RECEIVED CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AQ, CARTRIDGE-FP - LOT NUMBER UNK