BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON 5

    MDR report key: 384207 · Received March 21, 2002

    Report

    Report Number
    9610566-2002-00009
    Event Type
    Injury
    Date Received
    March 21, 2002
    Date of Event
    February 19, 2002
    Report Date
    March 7, 2002
    Manufacturer
    PHARMACIA & UPJOHN, FYRISLAND
    Product Code
    LZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CORNEAL BURN (CORNEAL INJURY NOS). CORNEAL OPACITY (CORNEAL OPACITY). CASE DESCRIPTION: SPONTANEOUS DEVICE REPORT, LOCAL REF.N: 02-0895-S, ARGUS N: 2002096151GB. A CONSULTANT REPORTED A CASE REGARDING A PT (SEX AND AGE UNKNOWN) WHO UNDERWENT A SURGICAL INTERVENTION IN WHICH HEALON 5 WAS USED. FROM THE INFO RECEIVED THE BATCH SHOULD BE THE N. 5002323. THE PHYSICIAN REPORTED TO HAVE CALIBRATED PROPERLY THE PHACO PROBE WITH NORMAL FLOW. THE SCLERAL TUNNEL CREATED WAS ADEQUATELY WIDE. DURING SURGERY, NOTICED THAT THERE WAS NO SUCTION AND THE EMULSIFIED NUCLEAR MATERIAL STAYED OVERLYING THE SURFACE OF THE CATARACT AS A MILKY SUBSTANCE. HE ASKED TO CHECK THAT THERE WERE NO KINKS ON ALL THE TUBINGS. IT WAS ASCERTAINED THAT ALL THE TUBINGS WERE UNKINKED. AS THERE WAS STILL NO SUCTION, THE PHACO PROBE WAS REMOVED AND A SECOND NEW PROBE WAS USED. AT A FURTHER CHECK IT WAS FOUND THAT NO FLUID HAD BEEN ASPIRATED BY THE FIRST PROBE. WHEN THE SECOND PROBE STARTED TO BE USED, SOME WOUND CONTRACTION WAS NOTICED WITH THE ANTERIOR SCLERAL LIP DOWNWARDS INTO A MORE FROWN LIKE SHAPE. BESIDES, AN EPITHELIAL DISTURBANCE WAS NOTICED AS THOUGH THERE WERE SMALL BUBBLES ON THE EPITHELIUM. ON WIPING THE BUBBLES OFF, IT WAS FOUND THAT THERE WAS AN EPITHELIAL DEFECT AND THE UNDERLYING CORNEA WAS SLIGHTLY OPACIFIED. SOME STRIAE WERE EMANATING FROM THIS AREA OF THE CORNEA TO ABOUT HALFWAY DOWN TO THE REST OF THE CLEAR CORNEA. THE WOUND WAS ENLARGED BEFORE THE INTRODUCTION OF THE NEW PHACO PROBE TO MAKE SURE IT HAD NOT BECOME TIGHT FOLLOWING THE TISSUE SHRINKAGE. THE REST OF PHACOEMULSIFICATION OCCURRED WITHOUT EVENTS. AT THE END OF SURGERY, THE WOUND WAS CLOSED, THE ANTERIOR CHAMBER WAS REFORMED, THE CONJUNCTIVA WAS ALSO SUTURED DOWN WITH TWO INTERRUPTED VICRYL SUTURES. THE EYE WAS PADDED WITH CHLORAMPHENICOL OINTMENT FOLLOWING THE USE OF SUBCONJUNCTIVAL ZINACEF AND BETNOSOL. THE OUTCOME IS UNKNOWN. NO FURTHER INFO HAS BEEN PROVIDED. FOLLOW-UP MAR 2002. THE FOLLOWING NEW INFO HAS BEEN PROVIDED: THE ADVERSE EVENT WAS A THERMAL INJURY TO THE CORNEAL-SCLERAL TUNNEL AND NOT A CORNEAL EDEMA. THE PT'S CORNEA HAS BEEN REPAIRED AFTER HAVING BEEN PERFORATED. THE CASE WAS UPGRADED TO SERIOUS/MEDICALLY SIGNIFICANT BY A GPV PHYSICIAN. CORNEAL BURN HAS BEEN ADDED AS ADVERSE EVENT. CASE COMMENT: THE REPORTING PHYSICIAN ASSESSED THE EVENT AS NON SERIOUS. ACCORDING TO PHARMACIA SAFETY PROCEDURES NO MEDICAL COMMENT IS REQUIRED. PART OF THE ENERGY PRODUCED BY THE PHACOEMULSIFICATION TIP IS DISSIPATED AS HEAT. THE HEAT IS CONDUCTED INTO THE EYE ALONG THE TITANIUM TIP AND THEN COOLED BY THE ONGOING FLOW OF THE IRRIGATION-ASPIRATION FLUID. IF FOR ANY REASON THE FLOW IS BLOCKED, A CORNEAL BURN CAN OCCUR WITHIN 1-3 SECONDS. THE MOST COMMON CAUSE IS INADEQUATE FLOW THROUGH THE PHACOEMULSIFICATION TIP BECAUSE IT HAS BEEN OBSTRUCTED BY A RETENTIVE VISCOELASTIC AGENT; THIS PROBLEM ARISES FROM USING LOW FLOW AND VACUUM SETTINGS. THE CRITICAL WARNING SIGN IS THE APPEARANCE OF MILKY FLUID THAT IS PRODUCED AROUND THE TIP AS EMULSIFICATION IS BEGUN. TO AVOID CORNEAL BURNS, PHACOEMULSIFICATION AND IRRIGATION-ASPIRATION FUNCTIONS ALWAYS SHOULD BE TESTED BEFORE THE EYE IS ENTERED. SOME OF THE VISCOELASTIC MATERIAL THAT OVERLIES THE NUCLEUS CAN BE ASPIRATED PRIOR TO THE START OF EMULSIFICATION TO ASSURE THAT ASPIRATION IS ADEQUATE AND TO CREATE A SPACE IN FRONT OF THE CAPSULOHEREXIS. TO PREVENT CONSTRICTION OF THE IRRIGATING SLEEVE, AN INCISION SIZE THAT IS APPROPRIATE FOR EACH PARTICULAR PHACOEMULSIFICATION TIP SHOULD BE SELECTED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MEDICAL PERSONNEL, USER FACILITY, DISTRIBUTOR, MFR, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP (3/28/2002) - ALL THE INFO ARE DIRECTLY GIVEN BY TECHNICAL COMPLAINT INVESTIGATION: NO SAMPLE WAS RETURNED FOR INVESTIGATION. THUS, FIVE HEALON5 SYRINGES FROM THE REPORTED LOT NO WERE TAKEN OUT FROM CO'S REFERENCE STORAGE. THE SYRINGES WERE VISUALLY INSPECTED AND EXHIBITED NO CLOUDY SOLUTION OR MFG DEFECTS. THEY WERE ALSO ANALYZED FOR: APPEARANCE, IDENTIFICATION, ZERO SHEAR VISCOSITY, PH, MASS AVERAGE RELATEVE MOLECULAR MASS, ASSAY FOR SODIUMHYALURONATE AND OSMOLALITY. THE RESULT WAS FOUND TO BE WITHIN THE SPECIFICATION LUMITS FOR HEALON AND HEALON BV PRODUCTS. VISUAL INSPECTION AND BY LIGHT MICROSCOPY OF CO'S REFERENCE SAMPLES EXHIBITED NO MFG DEFECTS. THE BATCH DOCUMENTATION WAS REVIEWED AND NO SIGNIFICANT DEVIATION WAS FOUND. NO SIMILAR COMPLAINT IS REPORTED ON THIS BATCH. COMMENT 3/28/200 THE INVESTIGATION PERFOMED ON THE BATCH RECORDS DID NOT REVEALED ANY DEVIATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON 5 HYALURONATE SODIUM LZP PHARMACIA & UPJOHN, FYRISLAND NA 500 2323

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R