BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 12001775 · Received June 15, 2021

    Report

    Report Number
    3004750704-2021-07053
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 13, 2021
    Report Date
    October 29, 2021
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    04987617203481
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER: YES DATE RETURNED TO MANUFACTURER: SEP 8, 2021 DEVICE EVALUATION: THE COMPLAINT SAMPLE WAS RECEIVED AT THE MANUFACTURING SITE WHICH CONSISTED OF THE ACTIVATED CYLINDER (WITH APPROXIMATELY 0.3 ML OF EXPELLABLE SOLUTION), THE PLUNGER ROD, CYLINDER HOLDER AND THE CUSTOMER¿S CANNULA WITH PROTECTION SHEATH. THE ASSEMBLED SYRINGE WAS PLACED INTO A SMALL PLASTIC BAG WHICH HAD BEEN SEALED. AN OPHTHALMIC TRIANGULAR SPONGE WAS ALSO RECEIVED WHICH REPORTEDLY CONTAINED THE MATERIAL FIND. THE REMAINING SOLUTION WAS EXAMINED. THERE WERE NO OBSERVATIONS WHICH COULD EXPLAIN THE CUSTOMER'S OBSERVATION OF THE MATERIAL FIND. THE SOLUTION WAS CLEAR AND FREE OF PARTICULATES, FIBERS OR SIMILAR. THE RECEIEVED COMPONENTS WERE ALSO INPECTED AND NO OBSERVATIONS RELATED TO THE COMPLAINT NARRATIVE NOR TO THE REPORTED DEVICE PROBLEM WAS OBERVED. FOREIGN MATTER ANALYSIS: THE FOURIER TRANSFORM INFRARED (FTIR) MICRO-SPECTROSCOPIC ANALYSIS OF THE RECOVERED PARTICLES HAS INDICATED THAT THE MATERIAL IS SPECTRALLY SIMILAR TO POLYPHENYLENE SULFIDE (PPS). THERE IS AT LEAST ONE OTHER MATERIAL OBSERVED IN THE SPECTRUM OF THE MATERIAL FIND, BUT THIS HAS NOT BEEN IDENTIFIED. A SURVEY OF THE WORKERS¿ CLOTHING (CLEANROOM GOWNS, GLOVES, HEAD AND FACE COVERS, CLEANROOM BOOTS ETC), THE CLEANING EQUIPMENT (MOPS, WIPES, ETC), THE MANUFACTURING EQUIPMENT (INCLUDING HOSES AND O-RINGS) AND THE MANUFACTURING FACILITIES¿ FLOORS, CEILINGS AND WALLS, THERE IS CURRENTLY NO KNOWN SOURCE OF THE RECOVERED MATERIAL IN THE JOHNSON AND JOHNSON SURGICAL VISION (JJSV) MANUFACTURING FACILITY. ALSO, NONE OF THE JJSV SUPPLIED SYRINGE COMPONENTS (PERFORATION NEEDLE, RUBBER MEMBRANE, RUBBER PLUNGER, PLUNGER ROD, GLASS CYLINDER, LABELS AND CYLINDER HOLDER) CONTAIN THIS MATERIAL AND THEREFORE ARE NOT A SOURCE OF THIS PARTICLE. THE CANNULA HAS BEEN SUPPLIED BY THE CUSTOMER AND IS THEREFORE NOT SUPPLIED BY JJSV. BASED ON THE INFORMATION OBTAINED, THERE IS NO INDICATION OF PRODUCT MALFUNCTION OR PRODUCT DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS PER GLOBAL COMPLAINT TRENDING. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. FOR THIS LOT, ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. A SEARCH FOR RELATED COMPLAINTS FOR THE LOT INVOLVED FROM THE LAST 12 MONTHS WAS CONDUCTED AND NO RELATED COMPLAINT(S) WERE FOUND. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: BASED ON THE NEW INFORMATION RECEIVED, IT WAS CLARIFIED THAT THE TITLE OF THE REPORTER IS PHYSICIAN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, THE HEALON IS NOT AN IMPLANTABLE PRODUCT. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE HEALON IS NOT AN IMPLANTABLE PRODUCT; THEREFORE, NOT EXPLANTED. PHONE NUMBER: (B)(6). PHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HEALON PRODUCT WAS INJECTED INTO THE CAPSULE, PRIOR TO INTRAOCULAR LENS (IOL) INSERTION, THE SURGEON VISUALLY CONFIRMED UNDER THE MICROSCOPE THAT A FOREIGN MATERIAL WAS GLITTERING IN THE PATIENT'S EYE. THE SURGEON REMOVED THE FOREIGN MATTER WITH FORCEPS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. REPORTEDLY, THE FOREIGN MATTER IS GRAY COLOR AND LOOKS LIKE A PIECE OF METAL. THE SIZE WAS ABOUT 1-2 MM. WHEN SURGEON REMOVED IT FROM THE PATIENT'S EYE WITH FORCEPS, IT COLLAPSED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901066 HEALON PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TH85ML UH31603 04987617203481

    Patients

    Seq Age Sex Outcome Treatment
    1