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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device knife, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHNN
Regulation Number 886.4350
Device Class 1

Device Problems
Fail-Safe Did Not Operate 265
Knife 145
Dull, Blunt 140
Failure to Cut 58
Device Operates Differently Than Expected 16
Particulates 8
Product Quality Problem 6
Tip 5
Adverse Event Without Identified Device or Use Problem 5
Material Deformation 4
Mechanical Problem 4
Device Contamination with Chemical or Other Material 3
Break 2
Bent 2
Scratched Material 2
Switch, Push Button 2
Difficult to Insert 2
Incorrect Software Programming Calculations 1
Detachment of Device or device Component 1
Device Difficult to Setup or Prepare 1
Mechanics Altered 1
Misassembled 1
Physical Resistance 1
Physical Property Issue 1
Inadequacy of Device Shape and/or Size 1
Total Device Problems 677

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc Irb II Aug-24-2019
2 Bausch & Lomb Inc Irb II Mar-05-2018
3 Beaver Visitec II Apr-09-2019
4 Beaver Visitec III Apr-04-2019
5 Beaver Visitec II Aug-09-2018

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