BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 726289 · Received June 15, 2006

    Report

    Report Number
    2023826-2006-00821
    Event Type
    Injury
    Date Received
    June 15, 2006
    Date of Event
    March 20, 2006
    Report Date
    May 19, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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 P990013.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A CC4204BF SINGLE PIECE COLLAMER LENS. THE LENS HAPTIC TORE UPON INSERTION INTO THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER LENS WAS INSERTED. NO SUTURES WERE REQUIRED TO CLOSE THE WOUND. THE REPORTER STATED THAT DURING LOADING NOT ENOUGH VISCOELASTIC WAS USED, CAUSING THE LENS HAPTIC TO TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention INJECTOR MODEL INDIGO-P, LOT NUMBER UNK| LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP INDIGO| CARTRIDGE MODEL SFC-25 FP, LOT NUMBER UNK