BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 2260910 · Received September 23, 2011

    Report

    Report Number
    2023826-2011-00825
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 24, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) WITH TORIC OPTIC. (B)(4) - VISION, LOSS OF VISUAL ACUITY. (B)(4) - LENS, DISCOLORATION OF. DEVICE REMAINS IMPLANTED. DEVICE EVALUATED BY MANUFACTURER? NO - LENS REMAINS IMPLANTED. EVALUATION: METHOD - LENS WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. CLAIM # (B)(4). LENS REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW. RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE RAW MATERIALS, MANUFACTURING, STERILIZATION AND PACKAGING PROCESSES OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT (NO CONCLUSION CAN BE DRAWN): 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).

    Description of Event or Problem · 1

    THE REPORTER STATED ONE OF THEIR PATIENTS HAD AN AA4203TL SILICONE TORIC SINGLE PIECE LENS IMPLANTED IN THEIR LEFT EYE (OS) BY A DIFFERENT DOCTOR AT ANOTHER FACILITY. THE DATE OF SURGERY WAS (B)(6) 2003. THE REPORTER STATED THEY STARTED SEEING THIS PATIENT IN 2006 AND AT A POST-OP VISIT IN 2009, THE VA WAS 20/30. AT A POST-OP VISIT ON (B)(6) 2011, THE VA WAS 20/70 AND THE LENS WAS A RUST/REDDISH COLOR. THE LENS REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK