BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14583257 · Received June 2, 2022

    Report

    Report Number
    3012236936-2022-01463
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 5, 2022
    Report Date
    August 17, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636101
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PT. INFO.: UNKNOWN/ ASKED BUT NOT AVAILABLE. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN 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

    ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY REVEALED FOLLOWING INFORMATION: SECTION A2: AGE/DATE OF BIRTH: (B)(6) 1933, 88 YEARS SECTION A3: GENDER: MALE SECTION B5: THE SURGEON WAS DR. (B)(6) ((B)(6)). THE EYE AFFECTED WAS LEFT AND A NEW LENS WAS INSERTED. SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D9: RETURNED TO MANUFACTURER ON: JUN 22, 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 HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. THE CARTRIDGE TIP WAS OBSERVED TO BE CRACKED OFF OF THE CARTRIDGE AND THE CARTRIDGE WAS ALSO OBSERVED TO BE CRACKED. INSPECTION OF THE PLUNGER ROD REVEALED THAT THE PLUNGER ROD TIP WAS BENT, IN A WAY CONSISTENT WITH A HANDPIECE THAT WAS DROPPED. THE LENS WAS CLEANED AND, SCRATCHES COULD BE IDENTIFIED ON THE OPTIC BODY. NO FURTHER ISSUES COULD BE IDENTIFIED WITH THE LENS. CONCLUSION: THE REPORTED COMPLAINT ISSUE WAS OBSERVED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. 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 DIFFICULT TO ADVANCE. ONCE IT WAS PUSHED THROUGH, THE LENS HAD SCRATCHES, THE INSERTER OVERRODE LENS AND THE LENS GOT STUCK IN THE CARTRIDGE. THE THERE WAS NO CONTACT WITH PATIENT'S OPERATIVE EYE AND THE EVENT WAS OBSERVED DURING HANDLING. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977637 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636101

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male