BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 17406391 · Received July 27, 2023

    Report

    Report Number
    3012236936-2023-01940
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 18, 2023
    Report Date
    January 11, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474501935
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE INFORMATION INDICATING THERE WAS AN INCISION ENLARGEMENT, THERE WAS NO PATIENT INJURY AND NO DELAY REPORTED AND THAT THE PATIENT OUTCOME IS UNKNOWN WERE INADVERTENTLY NOT ENTERED IN THE INITIAL MDR REPORT; THEREFORE, THE INFORMATION HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION B5: THERE WAS AN INCISION ENLARGEMENT, BUT NO DELAY AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME IS UNKNOWN. SECTION H6: HEALTH EFFECT IMPACT CODE: 4625 (HS-INCISION ENLARGED : INTRA OPERATIVE COMPLICATIONS). SECTION H6: HEALTH EFFECT CLINICAL CODE: 4581 (HS-INCISION ENLARGED : INTRA OPERATIVE COMPLICATIONS). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT HEALTH PROFESSIONAL BOX IN SECTION G2 OF INITIAL REPORT SUBMITTED WAS NOT MARKED. THIS SUPPLEMENTAL REPORT IS SUBMITTED TO CORRECT THIS. FIELD BELOW IS UPDATED: SECTION G2 BOX: HEALTH PROFESSIONAL.(CHECKED). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED BY THE DOCTOR IN THE PATIENT'S RIGHT EYE; HOWEVER, AFTER INSERTING THE IOL INTO THE EYE, THE DOCTOR NOTICED THAT ONE OF THE HAPTICS GOT STUCK IN THE CARTRIDGE. THE DOCTOR EXPLANTED THE IOL IMMEDIATELY AND IMPLANTED ANOTHER LENS OF THE SAME MODEL. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672596 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474501935

    Patients

    Seq Age Sex Outcome Treatment
    1 Female