BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 7850060 · Received September 6, 2018

    Report

    Report Number
    9614546-2018-00861
    Event Type
    Injury
    Date Received
    September 6, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474537583
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 11/01/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED IN A LENS CASE. VISUAL INSPECTION WITH UNAIDED EYE SHOWS THE LENS IS CONTAMINATED WITH DUST PARTICLES. THIS IS EXPECTED AS THE LENS WAS TRANSPORTED FROM CONTROLLED ENVIRONMENT DURING MANUFACTURING TO A NON-STERILE, NON-ENVIRONMENTAL CONTROLLED AREA. THE PRODUCT IS INSPECTED BY A QUALIFIED INSPECTOR USING A MICROSCOPE WITH A 12X MAGNIFICATION; THE PRODUCT IS DAMAGED AND SCRATCHED, WHICH CAN BE SEEN ON THE POSTERIOR SIDE OF THE OPTIC BODY. INVESTIGATION OF THE RETURN SAMPLE DOES NOT SUGGEST THAT THE DAMAGE IS INTRODUCED DURING MANUFACTURING. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(6). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD UNEXPECTED POSTOP-REFRACTION AFTER IMPLANTING ZCT100 TORIC INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE (OS). REPORTEDLY, THE SURGEON WAS COMPLAINING OF THE REFRACTION DIFFERENCE, WHERE POST-OP REFRACTION IS WORST THAN PRE-OP. PATIENT WAS ALSO EXPERIENCING ASTIGMATISM. FOR THOSE REASONS, LENS WAS EXPLANTED AND REPLACED WITH ZCT150 18.5 DIOPTER. PRE-OP REFRACTIONS OS: -1.00D / 0.50 X 172. POST-OP REFRACTIONS OS:-2.25D. K READING FOR OS: K1: 43.38 @173. K2: 45.24 @83. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694535 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT100 05050474537583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention