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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 lens, intraocular, toric optics
Regulation Description Intraocular lens.
Product CodeMJP
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
5 4 1 1 0 0

Device Problems
Device Dislodged or Dislocated 128
Adverse Event Without Identified Device or Use Problem 76
Insufficient Information 69
Device Operates Differently Than Expected 27
Break 12
Nonstandard device 10
Positioning Problem 9
Appropriate Term/Code Not Available 6
Malposition of device 5
Patient-Device Incompatibility 4
Device Markings / Labelling Problem 4
Mechanical Problem 4
Torn Material 3
Packaging Problem 3
Material Integrity Problem 3
Haptic 3
Leak / Splash 3
Material Opacification 2
Improper or Incorrect Procedure or Method 2
Material Split, Cut or Torn 2
Scratched Material 2
Unexpected Therapeutic Results 2
Material Rupture 2
Inadequacy of Device Shape and/or Size 2
Therapeutic or Diagnostic Output Failure 1
Device Contamination with Chemical or Other Material 1
Optical Distortion 1
Component or Accessory Incompatibility 1
Overcorrection 1
Collapse 1
Difficult or Delayed Positioning 1
Off-Label Use 1
Unstable 1
Degraded 1
Activation, Positioning or Separation Problem 1
Protective Measures Problem 1
Device Slipped 1
Device Inoperable 1
Component Missing 1
Lenses 1
Difficult to Fold or Unfold 1
Total Device Problems 400


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