BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 18983743 · Received March 26, 2024

    Report

    Report Number
    3012236936-2024-00670
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 5, 2024
    Report Date
    January 10, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474620704
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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: 03-JUN-2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A FIBER WAS RECEIVED INSIDE A SPECIMEN VIAL. THE FIBER WAS SENT OUT TO A THIRD-PARTY LABORATORY FOR EVALUATION. THE MATERIAL WAS IDENTIFIED AS A TITANIUM ALLOY. THE INSERTER USED WITH THE SMARTLOAD DEVICE TO INJECT THE LENS IS COMPOSED OF TITANIUM; HOWEVER, THE INSERTER WAS NOT RETURNED FOR EVALUATION. UNUSED SAMPLES OF AN UNFOLDER VITAN INSERTER (LOT 0015) AND LAMINAR FLOW PHACO TIP, 21 GAUGE STRAIGHT TIP (LOT 5062516) WERE PROVIDED FOR MATERIAL CHARACTERIZATION TO ESTABLISH BASELINE COMPOSITION OF THE CONSUMABLES THAT MAY BE USED IN COMBINATION WITH THE SMARTLOAD. BOTH UNITS WERE ANALYZED AND CONFIRMED ALL SAMPLES ANALYZED FOR THE UNUSED INSERTER AND PHACO TIP WERE CONSISTENT WITH A TITANIUM ALLOY. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" 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. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 11-APR-2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A FIBER WAS RECEIVED INSIDE A SPECIMEN VIAL. FURTHER EVALUATION OF THE FIBER IDENTIFIED THE MATERIAL AS A TITANIUM ALLOY. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" 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: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND CORRECTED DATA: PRODUCT INVESTIGATION WAS UPDATED, THE SENTENCE BELOW WAS ADDED, RELATING TO THE INSERTER. THE INSERTER USED WITH THE SMARTLOAD DEVICE TO INJECT THE LENS IS COMPOSED OF TITANIUM; HOWEVER, THE INSERTER WAS NOT RETURNED FOR EVALUATION. UPDATED PRODUCT INVESTIGATION DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A FIBER WAS RECEIVED INSIDE A SPECIMEN VIAL. FURTHER EVALUATION OF THE FIBER IDENTIFIED THE MATERIAL AS A TITANIUM ALLOY. THE INSERTER USED WITH THE SMARTLOAD DEVICE TO INJECT THE LENS IS COMPOSED OF TITANIUM; HOWEVER, THE INSERTER WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6) SECTION H3 - OTHER (81): 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A SMALL PIECE OF "STEEL WIRE" FOLLOWED THE LENS INTO THE EYE. ACCOUNT INDICATED THAT THE LENS WAS NOT DAMAGED AND THE FOREIGN MATERIAL WAS REMOVED WITH TWEEZERS. THE EYE WAS NOT AFFECTED AND THE PATIENT WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048647 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GCB00 05050474620704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown