BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1192135 · Received October 7, 2008

    Report

    Report Number
    2023826-2008-01246
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 11, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED A SMALL TEAR IN THE OPTIC AND EVIDENCE OF A CLEAR SURGICAL RESIDUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS AND BEFORE DISCOVERING THE PATIENT'S ZONULES WERE BROKEN. THE LENS WAS REMOVED WITHOUT FURTHER INCIDENT. THE REPORTER STATED THE INCIDENT WAS DUE TO A PRE-EXISTING PT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention INJECTOR MODEL UNK| CARTRIDGE MODEL UNK