BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 20011705 · Received August 21, 2024

    Report

    Report Number
    3012236936-2024-000228
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474501973
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTED DATA: ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S WEIGHT WAS 63KG (138LBS). IN REVIEW, IT WAS NOTICED THAT AN INCORRECT VALUE (16KG) WAS INADVERTENTLY ENTERED IN THE SECTION "A4 -WEIGHT"; THEREFORE THE INFORMATION HAS BEEN CORRECTED ON THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD HAS BEEN CORRECTED ACCORDINGLY: SECTION A4: WEIGHT: 63KG (138LBS). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES . DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SUSPECT PRODUCT AND FOUND THE LENS WAS RECEIVED CUT AND BOTH HAPTICS WERE DETACHED. ONE HAPTIC REMAINED IN THE DRILL HOLE, BUT WAS CUT. THE OPTIC BODY WAS ALSO DAMAGED. NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE "HAPTIC DAMAGED" WAS NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED ONE ADDITIONAL COMPLAINT WAS RECEIVED FOR THIS PO. HOWEVER, BASED ON THE RESULTS, NO ESCALATIONS ARE REQUIRED. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. 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 SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME SURGERY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAPTIC OF A MONOFOCAL INTRAOCULAR LENS (IOL) WAS SEEN TO BE BENT ONCE INSERTED INTO A PATIENT'S RIGHT EYE. IT WAS INDICATED THAT THE ISSUE WAS NOT DUE TO USE ERROR. THE LENS WAS REMOVED AND THE SURGERY COMPLETED WITH A BACKUP LENS DURING THE SAME PROCEDURE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. THERE WAS NO UNPLANNED VITRECTOMY REQUIRED AND NO MEDICATION OUTSIDE THE STANDARD OF CARE REQUIRED. IT IS UNKNOWN IF THERE WAS ANY DELAY IN PROCEDURE. THE PATIENT OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION FROM THE DOCTOR INDICATED THAT THERE WAS A DISLOCATION OF THE CRYSTALINE LENS, SO THE LENS AND CAPSULE WERE REMOVED IN TOTAL AND THE IOL WAS PLACED VIA A SCLERAL FIXATED TECHNIQUE WITHOUT SUTURING THE LENS. THE SCLEROTOMY SITES WERE SUTURED. THIS IS STANDARD FOR THIS PROCEDURE. THE CORNEA ALSO HAD A CORNEL SUTURE PLACED WHICH IS ALSO STANDARD. THE PATIENTS VISION IS NOW 20/70 BACK TO HIS BASELINE AND BEST EXPECTED CORRECTED VISUAL ACUITY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153462 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474501973

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male EMERALD CARTRIDGE, LOT UNKNOWN.