BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1060844 · Received June 5, 2008

    Report

    Report Number
    2023826-2008-00783
    Event Type
    Other
    Date Received
    June 5, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENS BOX WAS RECEIVED WITH NO LENS INSIDE IT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED AN ASPHERIC COLLAMER LENS MODEL CQ2015A WITH NO PATIENT INJURY OR PRODUCT DAMAGED HOWEVER, THE SURGEON REALIZED THAT HE PUT IN THE WRONG DIOPTRIC POWER. THE SURGEON REMOVED THE LENS THRU THE SAME INCISION AND PUT IN A DIFFERENT POWER LENS. NO PATIENT INJURY. THE REPORTER STATED THAT THERE WAS NO PRODUCT ISSUE IT WAS A SURGICAL ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL: CQ CARTRIDGE-FP LOT NUMBER: UNK| INJECTOR MODEL: MSI-PM LOT NUMBER: UNK