BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON DUET

    MDR report key: 3524244 · Received December 17, 2013

    Report

    Report Number
    2020664-2013-00117
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    October 30, 2013
    Report Date
    November 22, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 WE RECEIVED A REPORT VIA A SALES REPRESENTATIVE THAT A PHYSICIAN REPORTED SHE HAD 5 OUT OF 8 PATIENTS WITH HIGH POST-OP, DAY ONE INTRAOCULAR PRESSURE (IOP) AFTER USING HEALON DUET. THE SURGEON DID NOT PROVIDED ANY PATIENT SPECIFIC INFORMATION NOR DID SHE PROVIDED ANY SPECIFIC DEVICE INFORMATION. SHE DID MENTION A PATIENT WITH PRESSURES ''IN THE 50'S''. SHE DID NOT WANT TO BE CONTACTED TO PROVIDED ADDITIONAL INFORMATION. A WEEK LATER, ON (B)(6) 2013 THE PHYSICIAN PROVIDED ADDITIONAL DETAILS REGARDING HER REPORT. THE SURGEON INDICATED THAT SHE FIRST USED HEALON WITHOUT ANY DIFFICULTIES. SHE THEN USED THE HEALON ENDOCOAT; SHE NOTED THAT THE VISCOSITY OF THE PRODUCT SEEMED THICKER THAN USUAL AND REPORTED THE FLUID TO ¿BULK OUT¿ AFTER INJECTION. SHE FURTHER REPORTED SHE USED THE SAME AMOUNT OF OPHTHALMIC VISCOELASTIC/DISPERSIVE (OVD) AS SHE DID IN THE PAST, AND THERE WAS NOTHING NEW OR DIFFERENT IN THE PROCEDURE. SHE STATED THAT SHE FELT THE INCREASED IOP WAS DUE TO THE HEALON ENDOCOAT AND NOT THE HEALON. THE DOCTOR HAS BEEN USING THE HEALON DUET OVD FOR THREE MONTHS WITH NO REPORTED ISSUES. ADDITIONALLY, THE SURGEON INDICATED THAT SHE USED THE SAME LOT NUMBER OF OVD ON SEVEN OTHER PATIENTS WHO DID NOT EXPERIENCE A RISE IN INTRAOCULAR PRESSURE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA P810031/S046. HEALON DUET LOT # UM30662 CONTAINS: HEALON LOT# UM30562; HEALON ENDOCOAT LOT# 024887: MANUFACTURE DATE MAY 06, 2013 AND EXPIRATION DATE APRIL 30, 2015. A REVIEW OF THE MANUFACTURING RECORDS FOR THE HEALON DUET LOT# UM30662 SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. MANUFACTURING RECORDS FOR THE HEALON LOT# UM30562 WERE REVIEWED AND ALL RESULTS MET SPECIFICATION. BASED ON THE MANUFACTURING RECORD REVIEW FOR THE HEALON DUET AND HEALON, THERE WERE NO ISSUES IDENTIFIED THAT WERE RELATED TO THE REPORTED COMPLAINT AS ALL FINISHED PRODUCT CHEMICAL AND MICROBIOLOGICAL TESTING WERE CONFIRMED TO MEET FINISHED PRODUCT SPECIFICATIONS. BATCH RELATED ENVIRONMENTAL MONITORING CONTROLS, E.G. AIR SAMPLING AND SURFACE SAMPLING ON ASEPTIC PACKAGING MET SPECIFIED LIMITS. MANUFACTURING RECORDS FOR HEALON ENDOCOAT WERE REVIEWED WITH SPECIAL EMPHASIS FOR CHARACTERISTICS THAT COULD BE POTENTIALLY RELATED TO THE OBSERVATION OF INCREASED INTRAOCULAR PRESSURE (IOP). REVIEW OF THE MANUFACTURING BATCH RECORDS FOUND NO DEVIATIONS THAT COULD LIKELY CONTRIBUTE TO THE INCREASED IOP REPORTED FOLLOWING THE USE OF HEALON ENDOCOAT. ALL PRODUCT TESTING MET SPECIFICATIONS FOR BOTH IN-PROCESS AND FINAL RELEASE. REGARDING HEALON ENDOCOAT: VISUAL INSPECTION OF THE UNOPENED RETURNED UNIT WAS PERFORMED. NO DEFECTS WERE OBSERVED ON THE UNITS. REGARDING HEALON: VISUAL INSPECTION OF RETAINED AND RETURNED SAMPLES WAS PERFORMED. NO VISIBLE DEFECTS WERE FOUND ON THE PACKAGE, SOLUTION OR CANNULA. ADDITIONAL CHEMICAL TESTING, ZERO SHEAR VISCOSITY AND ASSAY FOR SODIUM HYALURONATE WAS PERFORMED ON THE RETAINED SAMPLES; BOTH ITEMS WERE FOUND TO BE WITHIN SPECIFICATIONS. HEALON DUET: VISUAL INSPECTION OF RETURNED BOXES OF HEALON DUET WERE FOUND TO BE SLIGHTLY DAMAGED. THE SOURCE, AND THEREFORE THE PROBABLE CAUSE, FOR THE DAMAGE OF THE DUET BOXES IN NOT KNOWN. THE SLIGHT DAMAGE THAT WAS OBSERVED WAS DETERMINED NOT TO BE A PRODUCT DEFECT OR MALFUNCTION THAT COULD EXPLAIN INCREASED INTRAOCULAR PRESSURE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE FIVE UNOPENED RETURNED PRODUCTS FROM THE SAME LOT NUMBER WAS PERFORMED. NO DEFECTS WERE OBSERVED FOR THE UNITS. VISCOSITY TESTING WAS PERFORMED ON THE SAME FIVE UNOPENED RETURNED UNITS AND ALL RESULTS MET RELEASE SPECIFICATIONS. THERE WERE NO DEVIATIONS OR COMMENTS OBSERVED THAT INDICATED LIKELY ASSOCIATION WITH A MANUFACTURING ASSIGNABLE CAUSE. ADDITIONAL INFORMATION: HEALON LOT #UM30562, MANUFACTURE DATE: 01/21/2013, EXPIRATION DATE: 01/31/2015. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE OF EVENT: (B)(6) 2013. LOT #: UM30662. CONCOMITANT MEDICAL PRODUCTS: B. BRAUN BALANCED SALT SOLUTION, HEALON. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A PHYSICIAN THAT A PATIENT EXPERIENCED INCREASED INTRAOCULAR PRESSURE (IOP) ONE DAY POST-OPERATIVE FOLLOWING THE IMPLANTATION OF AN INTRAOCULAR LENS AND USE OF HEALON DUET. ON (B)(6) 2013: DAY ONE POST-OP IOP WAS 32 MM HG. ON (B)(6) 2013 DAY 12 POST OP IOP WAS 30 MM HG. ON (B)(6) 2013 - DAY 13 DAY POST OP IOP WAS 24. ON (B)(6) 2013 ¿ DAY 15 DAY POST OP IOP WAS 23. ON (B)(6) 2013 - DAY 22 DAY POST OP IOP WAS 16. PATIENT HAS NO PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658613 HEALON DUET OVDS LZP ABBOTT MEDICAL OPTICS 10-2900-80

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other