Z-0612-03

SKBM Microkeratome cutting tool

Name: Z-0612-03 SKBM Microkeratome cutting tool
Creator: Alcon Laboratories, Inc
Published: 2002-11-18
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2002-11-18 / Terminated

FDA source

Alcon Laboratories, Inc began a recall of SKBM Microkeratome cutting tool on 2002-11-18. The reason FDA records is "Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0612-03
Status: Terminated
Initiated: 2002-11-18
Posted: 2003-03-06
Terminated: 2003-07-08
Recalling firm: Alcon Laboratories
Product: SKBM Microkeratome cutting tool
Product code: HNO Keratome, Ac-Powered
Reason for recall: Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
FDA root cause: Other
Action: 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.
Quantity in commerce: 567
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 codes and lots: 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 code HNO

K980675Class ISummit Krumeich-Barraquer MicrokeratomeSummit Technology, Inc. / cleared 1998-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)