BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1101887 · Received August 7, 2008

    Report

    Report Number
    2023826-2008-01029
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 17, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A HAPTIC WAS BENT AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS, THE CAPSULE WAS UNABLE TO SUPPORT THE LENS. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISION AND A VITRECTOMY WAS PERFORMED. SUTURES CLOSED THE WOUND AFTER AN ACL WAS IMPLANTED. THE REPORTER STATED THE INCIDENT WAS DUE TO A PRE-EXISTING PT CONDITION AND THERE WAS NO ALLEGATION AGAINST THE PRODUCTS.

    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 Required Intervention INJECTOR MODEL MSI-TM| CARTRIDGE MODEL AQ CARTRIDGE-FP