BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON

    MDR report key: 12930404 · Received December 4, 2021

    Report

    Report Number
    3012236936-2021-00144
    Event Type
    Injury
    Date Received
    December 4, 2021
    Report Date
    December 4, 2025
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    5050474651692
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH (MONTHS): AGES ARE 52.21 ± 14.49 YEARS (RANGE 12¿86 YEARS). SEX/GENDER: 33 (51.6%) MALES AND 31 (48.4%) FEMALES. WEIGHT & ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS 25-OCT-2019. LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: THE UDI NUMBER IS UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. 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. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED AND THE REPORTED EVENT CANNOT BE CONFIRMED.. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD COULD NOT BE PERFORMED AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. CITATION: MALHOTRA C., DHINGRA D., NAWANI N., CHAKMA P., JAIN A., K., PHACOEMULSIFICATION IN POSTERIOR POLAR CATARACT: EXPERIENCE FROM A TERTIARY EYE CARE CENTRE IN NORTH INDIA. INDIAN J OPHTHALMOL 2020;68:PP. 589-94. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: PHACOEMULSIFICATION IN POSTERIOR POLAR CATARACT: EXPERIENCE FROM A TERTIARY EYE CARE CENTRE IN NORTH INDIA A RETROSPECTIVE STUDY WAS DONE TO DETERMINE THE RATE OF POSTERIOR CAPSULAR RUPTURE (PCR) AND ASSESS THE POSTOPERATIVE OUTCOMES IN PATIENTS OF POSTERIOR POLAR CATARACT (PPC) UNDERGOING PHACOEMULSIFICATION USING A COMBINATION OF ¿V¿ OR ¿¿¿ NUCLEOFRACTIS AND VISCODISSECTION. A TOTAL OF 80 EYES (N=38 RIGHT AND N=42 LEFT) OF 64 PATIENTS UNDERWENT CATARACT SURGERY FOR PPC. DURING THE PROCEDURE, A COHESIVE VISCOELASTIC HEALON GV (ABBOTT MEDICAL OPTICS) CONTAINING 14 MG/ML SODIUM HYALURONATE WAS INJECTED TO INFLATE THE CAPSULAR BAG FOR INTRAOCULAR LENS IMPLANTATION. AFTER THE IOL INSERTION, RESIDUAL VISCOELASTIC WAS REMOVED WITH THE BIMANUAL IRRIGATION AND ASPIRATION TIP FROM BELOW THE IOL BY TILTING THE LENS AND INSERTING THE IRRIGATION TIP UNDER THE LENS SURFACE AND ALSO FROM ABOVE THE IOL. POSTOPERATIVE COMPLICATIONS INCLUDE POSTERIOR CAPSULAR RUPTURE (N=6 EYES) AND PERSISTENT POSTERIOR CAPSULAR PLAQUE (N=4 EYES). ANTERIOR VITRECTOMY WAS REQUIRED IN ALL CASES WITH PCR BECAUSE OF ASSOCIATED VITREOUS DISTURBANCE. IOL WAS IMPLANTED IN THE SULCUS IN ALL THESE CASES WITH PCR AS THE SIZE OF THE CAPSULAR DEHISCENCE WAS >50% OF THE ANTERIOR CAPSULORRHEXIS. THE 4 EYES WITH RESIDUAL (PERSISTENT) POSTERIOR CAPSULAR PLAQUES WERE MANAGED WITH ND:YAG LASER CAPSULOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828699 HEALON AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB HEALON GV UNKNOWN 5050474651692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention