BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_OVD_HEALON 5 PRO

    MDR report key: 11981141 · Received June 11, 2021

    Report

    Report Number
    3004750704-2021-07050
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 6, 2021
    Report Date
    December 4, 2025
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474701649
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO FOLLOW UP #1. UPON FURTHER REVIEW IT WAS NOTICED THAT SECTION D4: DEVICE CATALOG NUMBER WAS INADVERTENTLY REPORTED INCORRECT. THE CORRECT VALUES ARE AS FOLLOWS: SECTION D4. DEVICE CATALOG NUMBER: 10291015. PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - DESCRIBE EVENT OR PROBLEM: THROUGH FOLLOW-UP WE LEARNED THAT NOTHING FURTHER WAS FOUND AFTER POST-OP CHECKS. THE PATIENT HAS NO NEED FOR FURTHER CHECK UPS. THE LOT NUMBER OF THE PRODUCT WAS PROVIDED, THEREFORE THE FOLLOWING FIELDS WERE POPULATED ACCORDINGLY. SECTION D4 - LOT#: UH31340, SECTION D4 - CATALOG#: 30406800, SECTION D4 - EXPIRATION DATE: 31-JUL-2023, SECTION D4 - UDI #: (B)(4). SECTION H4 - DEVICE MANUFACTURE DATE: 31-AUG-2020. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: N/A. HEALON IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: N/A. HEALON IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE MATERIAL WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE PRODUCT COULD NOT BE REVIEWED BECAUSE NO LOT NUMBER WAS PROVIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INJECTING HEALON5 PRO INTO THE EYE A SMALL PIECE OF PLASTIC IS OBSERVED. THE SURGEON ASPIRATED THE PIECES OUT OF THE EYE. THIS HAS HAPPENED IN 3 CONSECUTIVE OPERATIONS 6.5.2021. ALL PATIENTS WILL BE POST-OP. CHECKED AFTER ONE MONTH AS ROUTINE CHECK. NO NEED FOR EXTRA INTERVENTION AT THIS POINT. THE MATERIAL IS NOT AVAILABLE FOR INVESTIGATION. NO OTHER INFORMATION WAS PROVIDED. THIS MDR IS TO CAPTURE 3 OF 3 OF THE UNKNOWN SERIAL NUMBER HEALON 5PRO SUSPECT PRODUCT COMPLAINT. 2 OTHER REPORTS ARE SUBMITTED TO CAPTURE THE OTHER 2 UNKNOWN SERIAL NUMBER HEALON5 PRO SUSPECT PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475326 UNK_OVD_HEALON 5 PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TV60ML UH31340 05050474701649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown