BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2202271 · Received August 5, 2011

    Report

    Report Number
    2023826-2011-00699
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CAPSULAR DEFECTS. EVAL METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): THE PRODUCT PERTAINING TO THIS CLAIM WAS NOT RETURNED FOR EVAL. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A LENS ACCOUNTABILITY FORM (LAF) FOR A AA4203TL TORIC OPTIC SILICONE SINGLE PIECE LENS WAS REC'D FROM THE FACILITY STATING THE SURGEON CHOSE A DIFFERENT LENS DUE TO CAPSULAR DEFECTS. THE FACILITY WAS CONTACTED BUT NO FURTHER INFO WAS AVAILABLE. LENS WAS DISCARDED.

    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 COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability