BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11129287 · Received January 7, 2021

    Report

    Report Number
    2648035-2021-07023
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    May 13, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636095
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 2/17/2021 SECTION H3: DEVICE EVALUATED BY MANUFACTURER ¿ YES DEVICE EVALUATION: THE SAMPLE WAS RECEIVED IN THE ORIGINAL BOX. THE LENS RETURNED OUT OF THE DEVICE AND CUT IN TWO PARTS. THE CARTRIDGE COMPONENT WAS OBSERVED CORRECTLY ENGAGED INTO THE SIMPLICITY PRELOADED UNIT. THE PLUNGER IS FULLY ADVANCED. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED. ONE HALF OF THE LENS WAS OBSERVED WITH BROKEN EDGE. NO RESIDUES OF LUBRICANT WERE OBSERVED AT ANY SECTION OF THE CARTRIDGE. THE USE OF BALANCED SALT SOLUTION (BSS) COULD NOT BE DETERMINATE ON THE RETURN. NO ASSEMBLY ERRORS AND/OR MANUFACTURING DEFECTS WERE IDENTIFIED ON THE SAMPLE RECEIVED. THERE WAS A DAMAGED ON THE EDGE OBSERVED, HOWEVER, NO SPECIFIC DAMAGED WAS REPORTED BY CUSTOMER. THE REPORTED ISSUE AS LENS CUT WAS CONFIRMED. HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT SAMPLE HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. THE UNIT WAS HANDLED AND USED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS PROVIDED, AND REPORTED, THERE WAS PATIENT CONTACT. LENS CUT AND REMOVED. NO OTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED; THEREFORE, IT WAS NOT EXPLANTED. 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 · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DROPPED OR WAS A DAMAGED LENS. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THE CUSTOMER NO LONGER HAD ANY INFORMATION AVAILABLE AS ALL THE INFORMATION WAS ON THE LENS BOX THAT WAS RETURNED BACK TO JOHNSON & JOHNSON SURGICAL VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26418 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636095

    Patients

    Seq Age Sex Outcome Treatment
    1