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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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New Search Show TPLC since Back To Search Results
Device implant, corneal, refractive
Product CodeLQE
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
0 1 4 4 4 0

Device Problems
Adverse Event Without Identified Device or Use Problem 149
Device Dislodged or Dislocated 68
No Apparent Adverse Event 12
Improper or Incorrect Procedure or Method 6
Contamination During Use 5
Labelling, Instructions for Use or Training Problem 5
Malposition of device 4
Biological Environmental Factor 4
Insufficient Information 3
Wrinkled 3
Use of Device Problem 3
Positioning Problem 2
Device Contamination with Chemical or Other Material 1
Material Fragmentation 1
Material Opacification 1
Environmental Particulates 1
Patient Device Interaction Problem 1
Material Disintegration 1
Total Device Problems 270

Recalls
Manufacturer Recall Class Date Posted
1 AcuFocus, Inc. II Mar-24-2016
2 RVO 2.0, INC I Mar-05-2019
3 Revision Optics Inc II Mar-21-2017

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