BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16841124 · Received April 29, 2023

    Report

    Report Number
    3012236936-2023-01083
    Event Type
    Injury
    Date Received
    April 29, 2023
    Report Date
    July 24, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474700291
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, THE EXPLANT EVENT REPORTED IN THE INITIAL REPORT IS THIS TIME CONSIDERED NOT REPORTABLE AS THE MONOFOCAL LENS WAS EXCHANGED FOR A MULTIFOCAL LENS AS THE MONOFOCAL LENS WAS NOT INTENDED TO TREAT NEAR VISION. THEREFORE, THIS FOLLOW-UP #1 IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2023-01083. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 6/29/2023. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE COMPLAINT LENS PRESENTED CUT IN HALF. THE LENS WAS CLEANED AND PRESENTED WITH NO ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE COMPLAINT ISSUES WERE NOT CONFIRMED. THE OTHER OBSERVED ISSUE DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. AS PER COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA AND ADDITIONAL INFORMATION: NEW INFORMATION WAS RECEIVED THAT EXPLANT OF THE SUSPECT LENS JUST TRANSPIRED ON (B)(6), 2023. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS, NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE, PATIENT WELL POST-OP, LENS IN GOOD POSITION. THIS CORRECTION MDR IS BEING SUBMITTED TO CORRECT INFORMATION PREVIOUSLY REPORTED. FIELD BELOW UPDATED. SECTION D6B: IF EXPLANTED, GIVE DATE: (B)(6) 2023. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, IT WAS NOTED IN THE 1ST FOLLOW-UP REPORT SUBMITTED THAT EXPLANTED LENS EVENT IS CONSIDERED NOT REPORTABLE AS THE MONOFOCAL LENS WAS EXCHANGED FOR A MULTIFOCAL LENS AND THE MONOFOCAL LENS WAS NOT INTENDED TO TREAT NEAR VISION. AND THAT THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2023-01083. HOWEVER, NEW INFORMATION RECEIVED THAT CONFIRMS THE SUSPECT LENS WAS NOT EVEN EXPLANTED YET AND THE DOCTOR PLANS TO EXPLANT THE LENS ON (B)(6) 2023. HENCE, CODE IN INITIAL MDR SUBMITTED IN SECTION H6: HEALTH EFFECT ¿ IMPACT CODE: 4629 (DEVICE REVISION OR REPLACEMENT) WAS INCORRECTLY REPORTED AND SECTION H6: HEALTH EFFECT: CLINICAL CODE 2137 (BLURRED VISION) WAS ALSO INADVERTENTLY REPORTED ALSO. THEREFORE, THIS FOLLOW-UP #2 IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA. FIELD BELOW UPDATED: SECTION H6: HEALTH EFFECT ¿ IMPACT CODE: 2199 (PT-TREATMENT NOT REQUIRED/NOT REPORTED). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED. BEST ESTIMATE OF DATE OF EVENT IS BETWEEN (B)(6) 2022 AND (B)(6) 2023. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. BEST ESTIMATE OF EXPLANT DATE IS (B)(6) 2023. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS HAVING DIFFICULTY READING WITH THE IMPLANTED INTRAOCULAR LENS (IOL) IN THE RIGHT/LEFT EYE, WHICH STARTED SOON AFTER SURGERY IN (B)(6) 2022. AN IOL EXCHANGE WITH A SYNERGY IOL IS PLANNED FOR (B)(6) 2023. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH NORMAL DAILY ACTIVITIES, INCLUDING NIGHT DRIVING. THE PRE-OPERATIVE TARGET REFRACTIVE VALUE WAS -0.25 AND THE FINAL REFRACTIVE VALUE POST-OPERATIVE WAS +-0.50. THROUGH FURTHER FOLLOW-UP, IT WAS LEARNED THAT THE EXPLANT HAS BEEN PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR RIGHT EYE, A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627738 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCU375 05050474700291

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention