BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2924849 · Received January 17, 2013

    Report

    Report Number
    2028159-2013-00093
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 1, 2009
    Report Date
    November 26, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A LITERATURE REPORT WAS RECEIVED AND WAS REVIEWED BY A CLINICAL ANALYST WHO NOTED THAT WITH THE LIMITED INFORMATION IN THE ARTICLE IT IS DIFFICULT TO ASCERTAIN IF THE COMPLICATIONS CITED ARE INDEED ATTRIBUTABLE TO AN ALCON PRODUCT. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. REN KL. PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION IN THE TREATMENT OF DIABETES COMPLICATED WITH CATARACT. GOUJI YANK ZAZHI (INT EYE SCI) 2012; 12 (10): 1990-1991. (B)(4).

    Description of Event or Problem · 1

    A LITERATURE REPORT WAS RECEIVED REPORTING THAT FROM DECEMBER 2009 THROUGH DECEMBER 2010, 32 CASES OF DIABETIC CATARACT PTS (46 EYES) HAD UNDERGONE PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATIONS. THERE WERE 12 MALES (20 EYES) AND 20 FEMALES (26 EYES) WITH A MEAN AGE OF 67.5 YEARS, RANGING FROM 48 TO 87 YEARS. PREOPERATIVE VISUAL ACUITY WAS FINGER COUNTING/10CM~0.4, AND THE NUCLEAR HARDNESSES WERE GRADE II IN 11 EYES, GRADE III IN 27 EYES AND GRADE IV IN 8 EYES RESPECTIVELY. FOR 15 PTS WITH DIABETIC RETINOPATHY STAGE I~IV, FUNDUS FLUORESCEIN ANGIOGRAPHY WAS CONDUCTED ONE WEEK LATER. FOR 6 PTS WITH DIABETIC RETINOPATHY STAGE III~IV, RETINAL PHOTOCOAGULATION WAS GIVEN. THE COMPLICATIONS RECORDED DURING AND AFTER SURGERY WERE AS FOLLOWS: CORNEAL EDEMA IN 10 EYES, DELAYED UVEITIS IN 6 EYES, POSTOPERATIVE HIGH INTRAOCULAR PRESSURE IN 4 EYES, "AFTER CATARACT" IN 3 EYES, POSTERIOR CAPSULAR RUPTURE IN 1 EYE. NO BULLOUS KERATITIS, FULMINANT CHOROIDAL HEMORRHAGE, INFECTIOUS ENDOPHTHALMITIS OR ANY OTHER SERIOUS COMPLICATIONS WERE NOTED. THIS IS THE SECOND OF FOUR REPORTS BEING FILED IN RELATION TO THIS ARTICLE. THIS CASE IS FOR THE POOL WITH DELAYED UVEITIS IN 6 EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25509 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TOBREX| TOBRADEX SUSP.