BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 734958 · Received November 17, 2005

    Report

    Report Number
    2023826-2005-01583
    Event Type
    Malfunction
    Date Received
    November 17, 2005
    Date of Event
    October 17, 2005
    Report Date
    October 18, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: (OTHER): VISUAL INSPECTION OF THE RETUNRED PRODUCT FOUND TH LERS STUCK IN THE CARTRIDGE. THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CC4204BF COLLAMER PLACE LENS, BUT THE LENS BECAME STUCK IN THE CARTRIDGE. THERE ARE NO PT CONTACT OR INJURY. THE REPORTER STATED THE CAUSE OF THE LENS BECOMING STUCK IN THE CARTRIDGE WAS SUE TO THE LENS NOT BEING LOADED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR CTP INDIGO MODEL - LOT NUMBER UNKNOWN.| INDIAGO-P INJECTOR MODEL - LOT NUMBER UNKNOWN,| SFC-25 FP CARTRIDGE MODEL - LOT NUMBER UNKNOWN,