BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 19867758 · Received July 30, 2024

    Report

    Report Number
    3012236936-2024-000203
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 30, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE CODES FROM THE INITIAL MDR OF (B)(4) TREATMENT NOT REQUIRED/NOT REPORTED IS NO LONGER APPLICABLE. THE FOLLOWING CODE HAVE BEEN ADDED TO REFLECT THE NEW INFORMATION: SECTION H6: CODE 4629: PT-EXPLANT: MEDICAL DEVICE REMOVAL. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS INFORMATION BELONGS TO SERIAL NUMBER:(B)(6) SECTION: A3B, A4- PATIENT'S WEIGHT: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION E1:SURGEON'S EMAIL ADDRESS AND PHONE NUMBER: UNKNOWN/ ASKED BUT NOT AVAILABLE. DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, DEVICE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIRST NON PRELOADED INTRAOCULAR LENS (IOL) HAD A LOADING ERROR WHEN ATTEMPTING TO INSERT THE LENS INTO THE PATIENT LEFT. THERE WAS NO PATIENT CONTACT. THE ISSUE WAS NOTICED DURING HANDLING AND PRIOR TO INSERTION. BACK UP LENS LENS WAS USED TO COMPLETE THE PROCEDURE. SECOND IOL WAS PLACED IN THE EYE AND DUE TO COMPLICATIONS WITH THE PROCEDURE THE LENS FELL BACK OF THE EYE. IT WILL BE EXPLANTED ON ANOTHER DATE. THE ISSUE WAS NOTICED DURING IMPLANTATION AND APPLICATION OF THE LENS. EXPLANT OF THE SECOND LENS IS PLANNED BUT HAS NOT OCCURRED. THERE WERE NO INCISION ENLARGED, UNPLANNED VITRECTOMY, OR ANY SUTURES REQUIRED. THERE WAS NO ANY INTERVENTION REQUIRED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT TECH COULDN'T GET LENS LOADED IN CARTRIDGE AND BENT THE HAPTIC TRYING. LENS WAS DISCARDED. 1ST LENS WAS DAMAGED BY TECH WHEN LOADING, BACKUP LENS FELL TO BACK OF EYE NOT FROM USER ERROR. MEDICAL/SURGICAL INTERVENTION WERE ALREADY PLANNED FOR THE CASE THE SITUATION WAS NOT THE CAUSE OF ENLARGEMENT, VITRECTOMY, OR SUTURE. THIS REPORT IS FOR THE BACK UP LENS (SECOND IOL). NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244503 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention