BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 574718 · Received February 18, 2005

    Report

    Report Number
    2023826-2005-00230
    Event Type
    Injury
    Date Received
    February 18, 2005
    Date of Event
    January 6, 2005
    Report Date
    January 20, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IMPLANTED LENS IN THE PT'S RIGHT EYE BUT REMOVED IT DUE TO A POSTERIOR CAPSULE TEAR AND VITREOUS PROLAPSE. AN ANTERIOR VITRECTOMY WAS PERFORMED. THE FACILITY INDICATED THAT THE INJURY WAS NOT PRODUCT-RELATED AND THERE WERE NO POST-OPERATIVE COMPLICATIONS. AN MSI-PF INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BUT THE LOT NUMBERS WERE NOT PROVIDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R