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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device extended depth of focus intraocular lens
Regulation Description Intraocular lens.
Definition Intended to be implanted to replace the natural lens of an eye.
Product CodePOE
Regulation Number 886.3600
Device Class 3

Device Problems
Adverse Event Without Identified Device or Use Problem 1630
Inadequacy of Device Shape and/or Size 179
Unintended Movement 123
Appropriate Term/Code Not Available 83
Scratched Material 38
Device Dislodged or Dislocated 29
Device Contamination with Chemical or Other Material 28
Break 21
Migration or Expulsion of Device 19
Crack 13
Mechanical Problem 12
Torn Material 10
Contamination / decontamination Problem 10
Invalid Sensing 9
Material Split, Cut or Torn 5
Incorrect Measurement 5
Dent in Material 5
Material Opacification 5
Difficult or Delayed Positioning 4
Contamination During Use 4
Product Quality Problem 3
Unexpected Therapeutic Results 3
Expulsion 3
Difficult to Insert 3
Malposition of device 3
Device Markings / Labelling Problem 3
Kinked 2
Detachment of Device or device Component 2
Premature Activation 2
Failure to Unfold or Unwrap 2
Unsealed Device Packaging 2
Material Integrity Problem 2
Patient-Device Incompatibility 2
Device Operates Differently Than Expected 2
Optical Decentration 2
Material Twisted / Bent 1
Physical Resistance 1
Wrinkled 1
Failure to Fold 1
Delivered as Unsterile Product 1
Use of Device Problem 1
Component Missing 1
Off-Label Use 1
Device Damaged by Another Device 1
Device Handling Problem 1
Patient Device Interaction Problem 1
Inaccurate Information 1
Positioning Failure 1
Hole In Material 1
Arcing 1
Material Deformation 1
Physical Resistance / Sticking 1
Difficult to Fold or Unfold 1
Defective Device 1
Device Damaged Prior to Use 1
Positioning Problem 1
Total Device Problems 2289


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