BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2781240 · Received October 10, 2012

    Report

    Report Number
    2023826-2012-00786
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 13, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION - PMA/510(K) - P880091. METHOD: DEVICE HISTORY RECORD REVIEW RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING, STERILIZATION AND PACKAGING 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, IT HAS BEEN DETERMINED THAT A POSSIBLE ROOT CAUSE OF THE EVENT MAY BE RELATED TO USER TECHNIQUE. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4). 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 NO VISIBLE DAMAGE TO THE LENS. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH 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 AN AQ2010V SILICONE THREE PIECE LENS BECAME STUCK IN THE INJECTOR. THE REPORTER STATED THE LENS WAS STICKY AND ANOTHER INJECTOR WAS USED BUT THE LENS BECAME STUCK AGAIN. ANOTHER LENS WAS USED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL AQ CARTRIDGE-FP - LOT NUMBER UNK| INJECTOR MODEL MSI-TM - LOT NUMBER UNK