BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 12147794 · Received July 9, 2021

    Report

    Report Number
    2648035-2021-08113
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    May 7, 2021
    Report Date
    September 17, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558168
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 7/15/2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE. THE PLUNGER AND PUSHROD WAS OBSERVED IN ADVANCED POSITION. THE PUSHROD WAS OBSERVED THAT OVERRIDES THE LENS IN THE CARTRIDGE. RESIDUES OF VISCOELASTIC MATERIAL WERE OBSERVED ON CARTRIDGE. THE CARTRIDGE TIP WAS OBSERVED SLIGHTLY DEFORMED. THE LENS WAS ALSO OBSERVED DAMAGED AND STUCK IN CARTRIDGE. BASED ON THE SAMPLE EVALUATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT UNIT HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A PRODUCT THAT WAS HANDLED AND PREPARE FOR SURGICAL PROCESS. THE COMPLAINT ISSUE REPORTED WAS VERIFIED. BASED ON THE ANALYSIS OF THE RETURN, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE ARE NO DISCREPANCIES FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). 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

    ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT EJECT FROM THE INSERTER. THERE WAS A PATIENT CONTACT AND CARTRIDGE TIP CONTACTS THE PATIENT EYE. ADDITIONAL DETAILS RECEIVED CONFIRMS THAT THERE WAS DAMAGE TO THE LENS. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE DONE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038864 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558168

    Patients

    Seq Age Sex Outcome Treatment
    1