BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 12178511 · Received July 15, 2021

    Report

    Report Number
    2648035-2021-08140
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 17, 2021
    Report Date
    October 19, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474548626
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D9: RETURNED TO MANUFACTURER ON: 7/22/2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED CUT IN HALF (ONLY ONE HALF RECEIVED) AND ALSO THE ALLEGED FOREIGN MATERIAL ON THE LENS, WHICH WAS THEN FORWARDED TO EAG LABORATORIES FOR FURTHER ANALYSIS. PER EAG LABORATORIES, THE PARTICLE IS IDENTIFIED AS POLYETHYLENE WITH AN EXCELLENT OVERLAP WITH THE REFERENCE POLYETHYLENE FROM THE EAG LIBRARY, CONFIRMING THE PROPOSED ASSIGNMENT. THE FOURIER TRANSFORM INFRARED (FTIR) SPECTROMETER SPECTRUM RAW DATA OUTPUT FILE GENERATED BY THE FOREIGN MATERIAL FROM EAG LABORATORIES WAS THEN COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND YIELDED TWO RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE TOP HIT WAS ¿290864TYVEK LID (CARTRIDGES)¿ WITH A 0.983139 CORRELATION. THE COMPLAINT ISSUE WAS CONFIRMED, HOWEVER BOTH POSITIVE HITS WERE EVALUATED BY MANUFACTURING SITE SUBJECT MATTER EXPERT (SME) WHO DETERMINED THAT BOTH POTENTIAL SOURCES OF THE FOREIGN MATERIAL WERE NOT USED OR PRESENT DURING THE MANUFACTURING OF AAB00 MODEL LENSES, AND THEREFORE THE COMPLAINT ISSUE CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING 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 FROM 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 · 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 FOREIGN DEBRIS WAS FOUND IN AAB00 MODEL INTRAOCULAR LENS(IOL) AFTER LENS WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE. DOCTOR COULD NOT REMOVE DEBRIS AND CHANGED IOL. THE VENT WAS OBSERVED AFTER INSERTION OF LENS INTO PATIENT'S EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. PATIENT WAS DOING FINE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072706 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AAB00 05050474548626

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 1MTEC CARTRIDGE