BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20281145 · Received September 23, 2024

    Report

    Report Number
    3012236936-2024-000242
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    July 30, 2024
    Report Date
    December 19, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636149
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: SEPTEMBER 24, 2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE DEVICE WAS RECEIVED WITH THE PLUNGER ROD PARTIALLY ADVANCED. THE CARTRIDGE TIP WAS DAMAGED/FOLDED/BENT IN A WAY THAT MAY HAVE RESULTED FROM BEING DAMAGED PRIOR TO LENS DELIVERY. VISCOELASTIC RESIDUE WAS DISTRIBUTED THROUGH THE ENTIRE LENGTH OF THE CARTRIDGE. THE LENS MODULE WAS INSPECTED AND PRESENTED WITH NO DAMAGE OR VISCOELASTIC RESIDUE. THE DEVICE ASSEMBLY WAS INSPECTED AND PRESENTED WITH NO ISSUES. THE PLUNGER ROD ADVANCEMENT WAS INSPECTED AND NO ISSUES WERE IDENTIFIED. THE COMPLAINT ISSUE "CARTRIDGE TIP CRACKED/DAMAGED" WAS IDENTIFIED 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. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE PRODUCT INVESTIGATION RESULTS WERE REVIEWED AND CORRECTED INFORMATION WAS MADE AVAILABLE. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE PLUNGER ROD WAS PARTIALLY ADVANCED WITH THE CARTRIDGE TIP WAS BENT IN A WAY THAT IS CONSISTENT WITH DAMAGE THAT MAY HAVE OCCURRED DURING SHIPPING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6B - EXPLANT DATE: NOT APPLICABLE, THE LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581: INCISION ENLARGED ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEFORMATION AT THE TIP OF THE CARTRIDGE OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THROUGH FOLLOW-UP WE LEARNED THAT THE INCISION NEEDED TO BE ENLARGED TO ALLOW THE SEEMINGLY LARGER CARTRIDGE TIP TO ENTER THE EYE. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER SURGICAL/ MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503470 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown