BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 726379 · Received June 15, 2006

    Report

    Report Number
    2023826-2006-00805
    Event Type
    Injury
    Date Received
    June 15, 2006
    Date of Event
    May 15, 2006
    Report Date
    May 16, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6 EVALUATION VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A HAPTIC HAD BEEN TORN OFF AND WAS MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE CONCLUSION NO CONCLUSION CAN BE DRAWN BASED ON THE COMPLAINT HISTORY AND EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION PMA # IS P990013

    Description of Event or Problem · 1

    THE SURGEON INSERTED A CQ2015 THREE PIECE COLLAMER LENS AND THE HAPTIC WAS TORN DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURED AFTER ANOTHER LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention INJECTOR MODEL MSI PM LOT NUMBER UNK| CARTRIDGE MODEL CQ CARTRIDGE PF LOT NUMBER UNK