BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT

    MDR report key: 2758514 · Received September 23, 2012

    Report

    Report Number
    3002037047-2012-00153
    Event Type
    Injury
    Date Received
    September 23, 2012
    Report Date
    August 22, 2012
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NO FURTHER INFORMATION IS EXPECTED. CITATION: NAOKI OZEKI, KENYA YUKI, DAISUKE SHIBA, SHIGETO SHIMMURA, DOGRU MURAT, KAZUO TSUBOTA. INTRAOCULAR PRESSURE ELEVATION AFTER DESCEMET'S STRIPPING ENDOTHELIAL KERATOPLASTY. JPN J OPHTHALMOL (2012) 56:307-311. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, THE SURGEON PRESENTED A RETROSPECTIVE ANALYSIS OF 48 EYES OF 46 PATIENTS UNDERGOING DESCEMENT'S STRIPPING ENDOTHELIAL KERATOPLASTY (DSEK) WITHOUT PREEXISTING GLAUCOMA AND INVESTIGATED THE RISK FACTORS FOR IOP (INTRAOCULAR PRESSURE) ELEVATION AND ITS EFFECTS ON ENDOTHELIAL TRANSPLANT SURVIVAL. THE SURGEON REPORTED THAT, FOLLOWING DSEK DURING WHICH THIS VISCOELASTIC WAS USED, EIGHT PATIENTS EXPERIENCED ELEVATED INTRAOCULAR PRESSURE (IOP) FOR WHICH GLAUCOMA THERAPY WAS NEEDED - SIX PATIENTS WERE TREATED WITH MEDICATION AND TWO PATIENTS REQUIRED TRABECULECTOMY. IOP ELEVATIONS WERE DIAGNOSED FROM TWO TO TEN MONTHS AFTER DSEK. IT WAS REPORTED THAT IOP ELEVATION APPEARS TO BE A COMMON POSTOPERATIVE COMPLICATION OF DSEK. FOR THIS PATIENT, IT WAS REPORTED THAT THE IRIDOCORNEAL ANGLE WAS OPEN AFTER DSEK. IOP ELEVATION WAS DIAGNOSED AT FOUR MONTHS POST-DSEK. IOP RANGE AFTER ELEVATION WAS 14-36 MMHG. ONE GLAUCOMA MEDICATION WAS PRESCRIBED. AT THE FIVE-MONTH FOLLOW-UP, THE GRAFT STATUS WAS CLEAR. THE SURGEON INDICATED THAT POST-DSEK ANGLE OBSERVATIONS DID NOT REVEAL ANGLE CLOSURE TO BE THE CAUSE OF IOP ELEVATION, WHICH LED HIM TO CONSIDER THAT STEROIDS MIGHT HAVE BEEN THE CAUSE. NO FURTHER INFORMATION IS EXPECTED. THERE ARE EIGHT MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE EIGHTH PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention FLUOROMETHOLONE 0.1% (FLUMETHOLON)| LEVOFLOXACIN (CRAVIT)| BETAMETHASONE SODIUM PHOSPHATE 0.1% (SANBETAZON)