BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2981568 · Received February 27, 2013

    Report

    Report Number
    2023826-2013-00164
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) WITH TORIC OPTIC. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. SPLIT. EVALUATION METHOD - WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF DARK SURGICAL RESIDUE ON THE LENS SURFACE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING, PACKAGING OR STERILIZATION PROCESSES OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE MISHANDLING OF THE LENS WITH FORCEPS THAT MAY HAVE BEEN TOO SHARP AND DAMAGED THE HAPTIC PRIOR TO REMOVAL FROM THE PACKAGE BY THE USER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON NOTED A SPLIT IN AN AA4203TL TORIC SILICONE SINGLE PIECE LENS WHEN LOADING. THERE WAS NO PATIENT CONTACT. THE REPORTER STATED THE LENS WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83430 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

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