BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN CUP (GORTEX)

    MDR report key: 10688342 · Received October 16, 2020

    Report

    Report Number
    3004178847-2020-00024
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    December 1, 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

    ADDITIONAL INFORMATION: SECTION D10: DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 11/3/2020. SECTION H3: DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: MICROBIOLOGICAL TESTING WAS NOT REQUIRED SINCE NO INFECTION TO THE CUSTOMER WAS REPORTED. BY CHECKING THE RETURNED OXYCUP, THERE WERE CONTAMINATIONS OF BLACK MOLD OBSERVED ON THE CAP. PER INITIAL REPORT PROVIDED BY THE CUSTOMER, THE OXYCUP WAS WASHED USING TAP WATER WHICH MAY CONTAMINATE THE OXYCUP. MANUFACTURING RECORD REVIEW: REPORTED LOT NUMBER ZH04569 WAS A KIT LOT. ITS FILLING LOT ZH04567 AND COMPOUNDING LOT ZH04566 WERE MANUFACTURED IN MAR 2020. 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. IN CONCLUSION, REPORTED LOT WAS DEEMED ACCEPTABLE FOR RELEASE PER MATERIAL AND PRODUCTS RELEASING MANAGEMENT. COMPLAINT DATA WAS TRENDED IN PREVIOUS 12 MONTHS BY THE REPORTED LOT NUMBER: ZH04569; SEARCH RESULT: TOTAL THREE COMPLAINTS WERE REPORTED FOR THE SAME LOT IN PREVIOUS 12 MONTHS. NO PRODUCT DEFECT WAS IDENTIFIED. CONCLUSION: BASED ON THE MANUFACTURING RECORD REVIEW AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO ESCALATION IS REQUIRED. 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 FEMALE CONSUMER. A SEPARATE REPORT WILL BE FILED FOR THE MALE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158791 ALLERGAN CUP (GORTEX) ACCESSORIES LPN JOHNSON & JOHNSON SURGICAL VISION, INC. AGNCG ZH04569 14987617002012

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLUTION LOT# ZH04568, TABLET LOT# 84485| SOLUTION LOT# ZH04568, TABLET LOT# 84485