BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN CUP (GORTEX)

    MDR report key: 10571657 · Received September 23, 2020

    Report

    Report Number
    3004178847-2020-00020
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 20, 2020
    Report Date
    December 31, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: MANUFACTURING RECORD REVIEW: THE REPORTED LOT NUMBER ZE07500 WAS A KIT LOT AND IT WAS PACKAGED IN NOV 2019. ALL THE RECORDS FOR PRODUCTION PROCESS WERE FOUND TO BE ACCEPTABLE, ALL TESTING ITEMS WERE COMPLETED AND MET SPECIFICATIONS, INCLUDING INCOMING PRIMARY MATERIALS INSPECTION AND PRODUCT PHYSICAL APPEARANCE INSPECTION. THERE WAS NO NON-CONFORMANCE RELATED TO THIS COMPLAINT. COMPLAINT DATA WAS TRENDED IN PREVIOUS 12 MONTHS BY THE REPORTED LOT NUMBER: ZE07500; SEARCH RESULT: TOTAL FIVE 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 · 0

    ADDITIONAL INFORMATION: SECTION D4: KIT NUMBER WAS PROVIDED ZE07500. SECTION D4: EXPIRATION DATE 07/31/2021 . SECTION H4: DEVICE MANUFACTURE DATE 07/11/2019. DEVICE EVALUATION: BY CHECKING OF THE RETURNED SAMPLES, NO LENS CUP WAS RETURNED, SO, THE REPORTED ISSUE CAN NOT BE CONFIRMED. MICROBIOLOGICAL TESTING WAS NOT REQUIRED SINCE NO CONTAMINATION OF SOLUTION OR INFECTION TO THE CUSTOMER WAS REPORTED. MANUFACTURING RECORD REVIEW: REPORTED SOLUTION LOT NUMBER ZE07383 WAS A LABELLING LOT. ITS FILLING LOT ZE07382 AND COMPOUNDING LOT ZE07381 WERE MANUFACTURED IN NOV 2019. 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: ZE07383; SEARCH RESULT: TOTAL FOUR 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

    GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: EXACT DATE UNKNOWN, INFORMATION NOT PROVIDED. BEST ESTIMATE IS (B)(6) 2020. ABOUT A WEEK BEFORE THE CONSUMER CALLED ON (B)(6) 2020. LOT NUMBER: UNKNOWN, NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURING DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM A CONSUMER STATING THAT A MOLD-LIKE SUBSTANCE WAS OBSERVED ON THE FILTER BEHIND THE LID OF THE CONTACT LENS CASE/CUP OF CONSEPT 1-STEP PRODUCT. CONSUMER RINSES THE CASE IN WATER AND LETS IT DRY NATURALLY. THE PRODUCT WAS OPENED IN (B)(6) 2020 AND THE OCCURRENCE WAS ABOUT A WEEK BEFORE THE REPORT WAS RECEIVED, BEST ESTIMATE IS (B)(6) 2020. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036804 ALLERGAN CUP (GORTEX) ACCESSORIES LPN JOHNSON & JOHNSON SURGICAL VISION, INC. AGNCG ZE07500

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLUTION LOT# ZE07383, TABLETS LOT# 83036| SOLUTION LOT# ZE07383, TABLETS LOT# 83036