BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 11697848 · Received April 20, 2021

    Report

    Report Number
    2648035-2021-07651
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    July 21, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPON FURTHER FOLLOW-UP, THE FOLLOWING SECTIONS ARE UPDATED TO REFLECT NEW INFORMATION RECEIVED. SECTION D1: BRAND NAME: TECNIS SECTION D2: TYPE OF DEVICE; LENS, INTRAOCULAR, TORIC OPTICS SECTION D3: PRODUCT CODE; MJP SECTION D4: MODEL NUMBER: ZCT100. SECTION D4: CATALOG#: ZCT1000245. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: EXPIRATION DATE: DEC 19, 2024. SECTION D4: UDI NUMBER: (B)(4). SECTION H4: DEVICE MANUFACTURE DATE: DEC 19, 2020. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE LENS REMAINS IMPLANTED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING PROCESS RECORD IN RELATION TO SUSPECT PRODUCT WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. 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 · 1

    AGE, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED, BEST ESTIMATE DATE IS (B)(6) 2021. MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG # IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. TELEPHONE NUMBER AND ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE SERIAL NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS HAVE 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 AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND DOCTOR FOUND A SCRATCH JUST OFF THE CENTER OF THE VISUAL AXIS. THE PATIENT VISION IS GOOD AND DOCTOR IS LEAVING THE IOL IN THE EYE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590054 TECNIS LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. ZCT100

    Patients

    Seq Age Sex Outcome Treatment
    1