BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2130675 · Received June 14, 2011

    Report

    Report Number
    2023826-2011-00525
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INCISION SUTURED, NO PRODUCT MALFUNCTION. CONCLUSIONS: THE PRODUCT PERTAINING TO THIS EVENT WAS DISCARDED. BASED ON THE COMPLAINT HISTORY, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO LOADING ERROR AND THE OFF-LABEL USE OF THE INJECTION SYSTEM WITH THIS MODEL LENS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A AA4203TL TORIC OPTIC SILICONE SINGLE PIECE LENS. THE TRAILING PLATE HAPTIC TORE DURING INSERTION INTO THE EYE. THE LENS WAS CUT IN HALF TO REMOVE FROM EYE. THE INCISION WAS ENLARGED AND THE WOUND WAS SUTURED. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. REPORTER STATED THE LENS WAS LOADED INCORRECTLY. THE LENS WAS DISCARDED. THE REPORTER STATED THEY USED AN INJECTION SYSTEM, WHICH HAS NOT BEEN APPROVED BY THE MANUFACTURER FOR USE WITH THIS LENS MODEL. THE REPORTER STATED THEY ARE AWARE THAT USING THIS INJECTION SYSTEM IS OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention INJECTOR SYSTEM: MODEL EPIPHANY, LOT # 110112A26E