SKBM Microkeratome cutting tool
FDA Recall Z-0612-03 · Posted 2003-03-06
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Recalling FirmAlcon Laboratories, Inc
Recall StatusTerminated
Product CodeHNO
Date Initiated2002-11-18
Date Terminated2003-07-08
Product Quantity567
Reason for Recall
Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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