BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 15071639 · Received July 21, 2022

    Report

    Report Number
    3012236936-2022-01840
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    March 9, 2022
    Report Date
    September 30, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750753
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ETHNICITY: UNKNOWN, INFORMATION WAS ASKED BUT NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED AND NO NON-CONFORMANCE REPORT (NC) WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS WERE MADE TO OBTAIN THE 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

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: JUL 22, 2022 . SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE AND STUCK THE HANDPIECE TRAY. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CONTRIBUTE TO BLURRY VISION COULD BE IDENTIFIED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS IS TO CORRECT THE INITIAL SUBMISSION SECTION E1 STATE, PROVINCE, OR TERRITORY: IT IS BLANK BUT SHOULD HAVE STATED CALIFORNIA. FIELD BELOW IS UPDATED: SECTION E1 STATE, PROVINCE, OR TERRITORY: CALIFORNIA. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    HEALTH CARE PROVIDER REPORTED THAT THEIR PATIENT IS EXPERIENCING BLURRY VISION IN THEIR RIGHT EYE. THE SYMPTOMS WERE REPORTED ONE DAY POST-OP AND ARE NOT DEBILITATING. THERE WERE NO COMPLICATIONS OR SURGICAL INTERVENTIONS SUCH AS A CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES. THE IOL WAS SUBSEQUENTLY EXPLANTED. THE REPLACEMENT INFORMATION WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199550 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750753

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention