BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2880970 · Received December 14, 2012

    Report

    Report Number
    1119421-2012-01567
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    January 1, 2010
    Report Date
    November 15, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, SHE HAS HAD DECREASED VISION WHICH INTERFERES WITH SEEING STREET SIGNS AND TELEVISION. THE CONSUMER REPORTED THE IMPLANTING SURGEON DID A LASER TREATMENT TO BOTH EYES TO TREAT HAZINESS, WHICH HELPED MINIMALLY. THE CONSUMER WAS SEEN FOR A SECOND OPINION AND WAS TOLD SHE JUST NEEDED SOME GLASSES TO CORRECT NEARSIGHTEDNESS. IN A FOLLOW UP, THE SURGEON REPORTED HE DOES NOT FEEL THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE CONSUMER WAS DIAGNOSED WITH POSTERIOR CAPSULE OPACIFICATION (PCO) IN BOTH EYES AND HAD A YAG LASER PROCEDURE PERFORMED. THE SURGEON REPORTED THE CONSUMER WAS OFFERED A LASIK PROCEDURE AT NO CHARGE TO RESOLVE HER SLIGHT REFRACTIVE ERROR. THE OUTCOME OF THE EVENT IS UNKNOWN AS THE CONSUMER MOVED OUT OF THE AREA AND HAS NOT FOLLOWED UP. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11013608

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention MONARCH III HANDPIECE| MONARCH D CARTRIDGE| DUOVISC