Devices

Device Recall SKBM Microkeratome

Model / Serial
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
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
SKBM Microkeratome cutting tool
Manufacturer
Alcon Laboratories, Inc
1 Event
- Recall of Device Recall SKBM Microkeratome

Manufacturer

Alcon Laboratories, Inc

Manufacturer Address
Alcon Laboratories, Inc, 6201 South Freeway, PO Box 6600, Fort Worth TX 76134-2099
Source
USFDA

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