BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC

    MDR report key: 2130027 · Received June 10, 2011

    Report

    Report Number
    3002037047-2011-00030
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    August 5, 2010
    Report Date
    May 12, 2011
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BATCH RECORD REVIEW SHOWED THAT ALL TESTING RESULTS ARE WITHIN SPECIFICATION. INVESTIGATION OF BATCH RECORDS COMPOUNDING AND FILLING: NO REMARKS RELATED TO THE MANUFACTURING PROCESS, THE STERILIZATION OF RAW MATERIALS, EQUIPMENT, COMPONENTS AND PRODUCT STERILIZATION. ALL RESULTS OF CHEMICAL, MICROBIOLOGICAL AND TOXICOLOGY TESTS WERE WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED A PATIENT EXPERIENCED IRIS DEGENERATION AND LOSS IN IRIS PIGMENTATION, PIGMENT DISPERSION AND IRREGULARITY IN THE PUPIL AFTER BILATERAL IMPLANTATION OF AN INTRAOCULAR LENS (IOL), WAS PERFORMED ON (B)(6) 2010. PER THE OPHTHALMIC SURGEON THERE WAS A TRAUMATIC INJURY TWO WEEKS AFTER THE IMPLANT. THE PHYSICIAN WAS NOT SURE ABOUT THE CAUSE OF THE LOSS IN IRIS PIGMENTATION. HE BELIEVED THE CAUSE MIGHT BE THE ATROPHY OF THE IRIS OR A RESULT OF A TOXIC REACTION TO ANOTHER PRODUCT USED DURING SURGERY: BALANCED SALT SOLUTION OR VISCOELASTIC. THE EVENT WAS TREATED WITH NON-STEROIDAL ANTI-INFLAMMATORY AND CORTICOIDS DROPS. THE LENS WAS EXPLANTED ON (B)(6) 2010. IN THE SURGEON'S OPINION, THIS PRODUCT MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA 09H04D

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention ACRYSOF CACHET LENSES| BALANCED SALT SOLUTION