BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2895759 · Received January 3, 2013

    Report

    Report Number
    2023826-2013-00006
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - LENS WORK ORDER SEARCH. RESULTS - VISUAL INSPECTION OF THE RETURNED LENS SHOWED A HAPTIC WAS BENT AND A CLEAR SURGICAL RESIDUE ON THE LENS. A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORK ORDER. (B)(4)

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE HISTORY REVIEW. RESULTS: BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE TO THIS COMPLAINT IS UNKNOWN. POSSIBLE CAUSES MAY BE MISHANDLING OF THE PRODUCT DURING OR AFTER REMOVAL FROM ITS PACKAGING. ALSO, THE SURGEON'S TECHNIQUE MAY HAVE CAUSED THE BENT HAPTIC. AFTER REVIEW OF THE DEVICE HISTORY RECORD IT HAS BEEN DETERMINED THAT NOTHING IN THE MANUFACTURING PROCESS CONTRIBUTED TO THE ROOT CAUSE OF THE COMPLAINT. IT IS UNLIKELY THAT A LENS WITH A BENT HAPTIC WOULD HAVE PASSED THROUGH THE FINAL INSPECTION UNNOTICED. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION AND DEVICE HISTORY REVIEW, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HAPTIC OF AN AQ2010V SILICONE THREE PIECE LENS WAS BENT WHEN THE PACKAGE WAS OPENED. LENS WAS NOT USED. NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2986 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR