BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 15023296 · Received July 14, 2022

    Report

    Report Number
    3012236936-2022-01817
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 20, 2022
    Report Date
    October 3, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731455
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. AN ATTEMPT WAS MADE TO OBTAIN MISSING INFORMATION. HOWEVER; TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: JUL 29, 2022. 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 COMPLAINT LENS WAS RECEIVED CUT IN HALF (ONE HALF MISSING). THE LENS WAS CLEANED AND, NO FURTHER ISSUES COULD BE IDENTIFIED WITH THE LENS. VISUAL INSPECTION OF THE HANDPIECE REVEALED THAT THE CARTRIDGE TIP AND CARTRIDGE WERE BENT IN WAY CONSISTENT WITH A HANDPIECE THAT WAS DROPPED. NO FURTHER ISSUES WERE OBSERVED. CONCLUSION: THE REPORTED COMPLAINT ISSUE OF CRACKED LENS WAS NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS ADVANCED INTO PATIENT'S RIGHT EYE, HOWEVER, WHEN THE LENS WAS OBSERVED THROUGH MICROSCOPE SURGEON OBSERVED IT WAS CRACKED. THE LENS WAS REMOVED IN PIECES AND A NEW JOHNSON & JOHNSON LENS OF SAME SPECIFICATIONS (SAME DIOPTER AND SIZE) WAS IMPLANTED WITHOUT ANY INCIDENCE. AFTER INSERTER PREP, THERE WAS NO DELAY IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS, NO STUCK LENS AND NOTHING UNUSUAL WAS NOTICED. IT WAS INDICATED THAT ROOM TEMPERATURE BALANCED SALT SOLUTION (BSS) WAS USED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063154 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731455

    Patients

    Seq Age Sex Outcome Treatment
    1 Male