BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2052217 · Received April 12, 2011

    Report

    Report Number
    2023826-2011-00315
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS (IOL), TORN, SPLIT, CRACKED. EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - (B)(4) (OTHER): DEVICE HISTORY RECORD REVIEW. RESULTS - (B)(4) (OTHER): A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND BOTH HAPTICS TORN INTO TWO PIECES. THE LENS WAS RETURNED IN LIQUID. CONCLUSIONS -(B)(4) (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON NOTED, AFTER EXAMINING A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS, THERE WAS A SLIGHT TEAR IN THE LENS. THE REPORTER STATED THE LENS WAS NOT LOADED OR USED AND THERE WAS NO PATIENT CONTACT. THE REPORTER STATED THE LENS WAS RECEIVED DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK