BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN CUP (GORTEX)

    MDR report key: 10688355 · Received October 16, 2020

    Report

    Report Number
    3004178847-2020-00025
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    December 15, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LPN
    UDI-DI
    14987617002012
    PMA / PMN Number
    P850088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT EVALUATION WAS PERFORMED AS THE CONSUMER DISCARDED THE LENS CASE. MANUFACTURING RECORD REVIEW: REPORTED LOT NUMBER ZH04871 WAS A KIT LOT. ITS FILLING LOT ZE04868 AND COMPOUNDING LOT ZE04866 WERE MANUFACTURED IN MARCH 2020. ALL THE RECORDS FOR PRODUCTION PROCESS WERE FOUND TO BE ACCEPTABLE, ALL TESTING ITEMS WERE COMPLETED AND MET SPECIFICATIONS, INCLUDING INCOMING CHEMICAL MATERIALS TESTING, PRIMARY MATERIALS INSPECTION, PRODUCT PHYSICAL APPEARANCE INSPECTION, BULK AND FINISHED PRODUCT CHEMICAL TESTING AND MICROBIAL TESTING, STERILIZATION RECORDS, ENVIRONMENT MONITORING AND WATER SYSTEM MONITORING. THERE WAS NO NON-CONFORMANCE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINTS FOR THE PREVIOUS 12 MONTHS BY THE REPORTED LOT NUMBER: ZH04871 REVEALED 4 TOTAL COMPLAINTS, HOWEVER, ONLY THE OBJECTIVE COMPLAINT WAS REPORTED FOR THE SIMILAR ISSUE. CONCLUSION: BASED ON MANUFACTURING RECORD REVIEW AND HISTORICAL COMPLAINT REVIEW, THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. THE LOT NUMBER PROVIDED IS FOR THE KIT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER COMPLAINED THAT SHE HAD BEEN USING CONCEPT 1-STEP WITH HER HUSBAND, BUT BOTH OF THEIR CONTACT CASES DEDICATED TO THE PRODUCT HAD GOTTEN MOLDY IN THE BOTTOM. THEY USUALLY WASH THEIR CASES WITH TAP WATER, AND LET THEM DRY NATURALLY, BUT SOMETIMES THE CASES DID NOT COMPLETELY DRY BY THE NEXT TIME OF TAKING CARE OF THEIR LENSES. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE MALE CONSUMER. A SEPARATE REPORT WILL BE FILED FOR THE FEMALE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155993 ALLERGAN CUP (GORTEX) ACCESSORIES LPN JOHNSON & JOHNSON SURGICAL VISION, INC. AGNCG ZH04871 14987617002012

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLUTION LOT# ZH04869, TABLET LOT# 84485| SOLUTION LOT# ZH04869, TABLET LOT# 84485