BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 11494681 · Received March 16, 2021

    Report

    Report Number
    2648035-2021-07387
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    January 21, 2021
    Report Date
    September 22, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474548695
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D9: RETURNED TO MANUFACTURER ON: 3/25/2021 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. THE LENS WAS CLEANED AND NO COSMETIC DEFECTS WERE OBSERVED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED NO ADDITIONAL COMPLAINTS THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODES 4625 SUTURES, 4625 INCISION ENLARGED, AND 4581 INCISION ENLARGED WAS INADVERTENTLY NOT INCLUDED IN SECTION H10. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. SECTION H6: HEALTH EFFECT: IMPACT CODE: 4625 SUTURES, 4625 INCISION ENLARGED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4581 INCISION ENLARGED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A AAB00 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED INTO THE EYE AND WAS REMOVED IN THE SAME SURGERY BECAUSE THE CAPSULE HAD A RENT. THE LENS WAS REMOVED WITH LENS CUTTERS AND 10-0 NYLON SUTURE WAS USED. IOL WAS PLACED SAME SURGERY. 20.0 A Z9002 20.0 DIOPTER LENS WAS IN THE SULCUS IN THE SAME SURGERY. PATIENT WENT HOME WITHOUT FURTHER PROBLEMS. ADDITIONAL DETAILS RECEIVED STATES THAT INCISION ENLARGEMENT WAS DONE TO ACCOMMODATE LENS CUTTERS AND VITRECTOMY WAS NOT PERFORMED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391548 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AAB00 05050474548695

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention PLATINUM CARTRIDGE LOT#CH14558.| PLATINUM CARTRIDGE LOT#CH14558.