Events

Device Recall SKBM Microkeratome 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Laboratories, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    25047
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0612-03
  • 사례 시작날짜
    2002-11-18
  • 사례 출판 날짜
    2003-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-07-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25056
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Keratome, Ac-Powered - Product Code HNO
  • 원인
    Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
  • 조치
    Customers have been notified in writing of this recall action (11/18/2002), and instructed to return all SKBM and/or Lasitome microkeratome products. All returned product will be physically segregated and dispositioned by Alcon. Recall Effectiveness checks will be attempted between 10%-100% of the consignees.

Device

Device Recall SKBM Microkeratome
  • 모델명 / 제조번호(시리얼번호)
    All codes are affected by Safety Alert: 98-3002-005; 98-3002-01-017; 98-3002-02-001; 98-3002-02-002; 98-3002-02-007-03; 98-3002-03-001; 98-3002-03-003; 98-3002-03-004; 98-3002-03-006; 98-3002-03-007; 98-3002-03-010; 98-3002-03-013; 98-3002-03 018; 092K14; 98-3002-04-001; 98-3002-04-002; 98-3002-04-003; 98-3002-04-004; 98 3002-04-005; 98-3002-04-006; 98-3002-04-007; 98-3002-04-008; 98-3002-04-009; 98-3002-04-010; 98-3002-04-011; 98-3002-04-012; 98-3002-04-013; 98-3002-04-014; 98-3002-04-015; 98-3002-04-016; 98-3002-04-017; 98-3002-04-018; 98-3002-04-019; 98-3002-04-020; 98-3002-04-021; 98-3002-04-022; 98-3002-04-023; 98-3002-04-024; 98-3002-04-025; 98-3002-04-026; 98-3002-04-027; 98-3002-04-028; 98-3002-04-029; 98-3002-04-030; 99-0204-001-IR; 99-0204-002-IR; 99-0304-003-IR; 99-0304-004-IR; 99-0304-005-IR; 99-0304-006-IR; 99-0304-007-IR; 99-0304-008-IR; 99-0304-009-IR; 99-0304-010-IR; 99-0504-011 -IR; 99-0404-001-GE; 99-0404-002-GE; 99-0404-003-GE; 99-0404-004-GE; 99-0404-005-GE; 99-0404-006-GE; 99-0404-007-GE; 99-0404-011-IR; 99-0404-012-IR; 99-0404-013-IR; 99-0404-014-IR; 99-0404-015-IR; 99-0404-016-IR; 99-0404-017-IR; 99-0404-018-IR; 99-0504-001-GE; 99-0504-002-GE; 99-0504-003-GE; 99-0504-004-GE; 99-0504-005-GE; 99-0504-006-GE; 99-0504-007 GE; 99-0504-008-GE; 99-0504-009- GE; 99-0504-010-GE; 99-0504-019-IR; 99-0504-020-IR; 99-3002-04-001; 99-3002-04-002; 99-3002-04-003; 99-3002-04-004; 99-3002-04-005; 99-3002-04-006; 99-3002-04-007; 99-3002-04-008; 99-3002-04-009; 99-3002-04-010; 99-3002-04-011; 99-3002-04-012; 99-3002-04-013; 99-3002-04-014; MK31001; MK31002; MK31003; MK31004; MK31005; MK31006; MK31007; MK31008; MK31009; MK31010; MK31011; MK31012; MK31013; MK31014; MK31015; MK31016; MK31017; MK31018; MK31019; MK31020; MK31021; MK31022; MK31023; MK31024; MK31025; MK31026; MK31027; MK31028; MK31029; MK31030; MK31031; MK31032; MK31033; MK31034; MK31035; MK31036; MK31037; MK31038; MK31039; MK31040; MK31041; MK31042; MK31043; MK31044; MK31045; MK31046; MK31047; MK31048; MK31049; MK31050; MK31051; MK31052; MK31053; MK31054; MK31055; MK31056; MK31057; MK31058; MK31059; MK31060; MK31061; MK31062; MK31063; MK31064; MK31065; MK31066; MK31067; MK31068; MK31069; MK31070; MK31071; MK31072; MK31073; MK31074; MK31075; MK31076; MK31077; MK31078; MK6021/G; MK6022/G; MK6023/G; MK6024/G; MK6025/G; MK6026/G; MK6027/G; MK6028/G; MK6029/G; MK6030/G; MK6031/G; MK6032/G; MK6033/G; MK6034/G; MK6035/G; MK6036/G; MK6037/G; MK6038; MK6039; MK6040; MK6041/J; MK6042; MK6043/G; MK6044; MK6045; MK6046; MK6047; MK6048; MK6060E; MK7000; MK7001; MK7002; MK7003; MK7004; MK7005; MK7006; MK7007; MK7008; MK7009; MK7010; MK7011; MK7012; MK7013; MK7014; MK7015; MK7016; MK7017; MK7018; MK7019; MK7020; MK7021; MK7022; MK7023; MK7024; MK7025; MK7026; MK7027; MK7028; MK7029; MK7030; MK7031; MK7032; MK7033; MK7034; MK7035; MK7036; MK7037; MK7038; MK7039; MK7040; MK7041; MK7042; MK7043; MK7044; MK7045; MK7046; MK7047; MK7048; MK7049; MK7050; MK7051; MK7052; MK7053; MK7054; MK7055; MK7056; MK7057; MK7058; MK7059; MK7060; MK7061; MK7062; MK7063; MK7064; MK7065; MK7066; MK7067; MK7068; MK7069; MK7070; MK7071; MK7072; MK7073; MK7074; MK7075; MK7076; MK7077; MK7078; MK7079; MK7080; MK7081; MK7082; MK7083; MK7084; MK7085; MK7086; MK7087; MK7088; MK7089; MK7090; MK7091; MK7092; MK7093; MK7094; MK7095; MK7096; MK7097; MK7098; MK7099; MK7100; MK7101; MK7102; MK7103; MK7104; MK7105; MK7106; MK7107; MK7108; MK7109; MK7110; MK7111; MK7112; MK7113; MK7114; MK7115; MK7116; MK7117; MK7118; MK7119; MK7120; MK7121; MK7122; MK7123; MK7124; MK7125; MK7126; MK7127; MK7128; MK7129; MK7130; MK7131; MK7132; MK7133; MK7134; MK7135; MK7136; MK7137; MK7138; MK7139; MK7140; MK7141; MK7142; MK7143; MK7144; MK7145; MK7146; MK7147; MK7148; MK7149; MK7150; MK7151; MK7152; MK7153; MK7154; MK7155; MK7156; MK7157; MK7158; MK7159; MK7160; MK7161; MK7162; MK7163; MK7164; MK7165; MK7166; MK7167; MK7168; MK7169; MK7170; MK7171; MK7172; MK7173; MK7174; MK7175; MK7176; MK7177; MK7178; MK7179; MK7180; MK7181; MK7182; MK7183; MK7184; MK7185; MK7186; MK7187; MK7188; MK7189; MK7190; MK7191; MK7192; MK7193; MK7194; MK7195; MK7196; MK7197; MK7198; MK7199; MK7200; MK7201; MK7202; MK7203; MK7204; MK7205; MK7206; MK7207; MK7208; MK7209; MK7210; MK7211; MK7212; MK7213; MK7214; MK7215; MK7216; MK7217; MK7218; MK7219; MK7220; MK7221; MK7222; MK7223; MK7224; MK7225; MK7226; MK7227; MK7228; MK7229; MK7230; MK7231; MK7232; MK7233; MK7234; MK7235; MK7236; MK7237; MK7238; MK7239; MK7240; MK7241; MK7242; MK7243; MK7244; MK7245; MK7246; MK7247; MK7248; MK7249; MK7250; MK7251; MK7252; MK7253; MK7254; MK7255; MK7256; MK7257; MK7258; MK7259; MK7260; MK7261; MK7262; MK7263; MK7264; MK7265; MK7266; MK7267; MK7268; MK7269; MK7270; MK7271; MK7272; MK7273; MK7274; MK7275; MK7276; MK7277; MK7278; MK7279; MK7280; MK7281; MK7282; MK7283; MK7284; MK7285; MK7286; MK7287; MK7288; MK7289; MK7290; MK7291; MK7292; MK7293; MK7294; MK7295; MK7296; MK7297; MK7298; MK7299; MK7300; MK7301; MK7302; MK7303; MK7304 MK7305; MK7306; MK7307; MK7308; MK7309; MK7310; MK7311; MK7312; MK7313; MK7314; MK7315; MK7316; MK7317; MK7318; MK7319; MK7320; MK7321; MK7322; MK7323; MK7324; MK7325; MK7326; MK7327; MK7328; MK7329; MK7330; MK7331; MK7332; MK7333; MK7334; MK7335; MK7336; MK7337; MK7338; MK7339; MK7340; MK7341; MK7342; MK7343; MK7344; MK7345; MK7346; MK7347; MK7348; MK7349; MK7350; MK7351; MK7352; MK7353; MK7354; MK7355; MK7356; MK7357; MK7358; MK7359; MK7360; MK7361; MK7362; MK7363; MK7364; MK7365; MK7366; MK7367; MK7368; MK8000; MK8001; MK8002; MK8003; MK8004; MK8005; MK8006; MK8007; MK8008; MK8074; MK8075; MK8076; MK8077; MK8078; MK8079; MK8080; MK8081; MK8082; MK8083; MK8084; MK8085; MK8086; MK8087; MK8088; MK8089; MK8090; MK8091; MK8092; MK8093; MK8094; MK8095; MK8096; MK8097; MK8098; MK8099; MK8100; MK8101; MK8102; MK8103; MK8104; MK8105; MK8106; MK8107; MK8108; MK8109; MK8110; MK8111; MK8112; MK8113; MK8114; MK8115; MK8116; MK8117; MK8118; MK8119; MK8120; MK8121; MK8122; MK8123; MK8124; MK8125; MK8127; MK9001; MK9002; MK9003; MK9004; MK9005; MK9006; MK9007; MK9008; MK9009; MK9010; MK9012; MK8009; MK8010; MK8011; MK8012; MK8013; MK8014; MK8015; MK8016; MK8017; MK8018; MK8019; MK8020; MK8021; MK8022; MK8023; MK8024; MK8025; MK8026; MK8027; MK8028; MK8029; MK8030; MK8031; MK8032; MK8033; MK8034; MK8035; MK8036; MK8037; MK8038; MK8039; MK8040; MK8041; MK8042; MK8043; MK8044; MK8045; MK8046; MK8047; MK8048; MK8049; MK8050; MK8051; MK8052; MK8053; MK8054; MK8055; MK8056; MK8057; MK8058; MK8059; MK8060; MK8061; MK8062; MK8063; MK8064; MK8065; MK8066; MK8067; MK8068; MK8069; MK8070; MK8071; MK8072; MK8073
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide and to the following foreign countries: Spain, Taiwan, UK, Mexico, Brazil, India, France, Ireland, China, Lebanon, Germany, Australia, Italy, Saudi Arabia, Greece, Japan, Netherland, Turkey, Korea, Romania, Latvia, Belgium, Switzerland, Malaysia, Thailand, Portugal, Phillipines, Canada, Sweden, Hungary, Argentina, Poland, Norway, Peru, Russia, Venezuela, Vietnam, Ecuador, Ukraine, Cyprus, Singapore, Chile, Nepal, Honduras, Colombia, and the Czech Republic.
  • 제품 설명
    SKBM Microkeratome cutting tool
  • Manufacturer
    Alcon Laboratories, Inc

Manufacturer

Alcon Laboratories, Inc
  • 제조사 주소
    Alcon Laboratories, Inc, 6201 South Freeway, PO Box 6600, Fort Worth TX 76134-2099
  • Source
    USFDA