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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aid, surgical, viscoelastic
Regulation Description Intraocular fluid.
Product CodeLZP
Regulation Number 886.4275
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
11 12 18 8 5 4

Device Problems
Adverse Event Without Identified Device or Use Problem 182
Device Contamination with Chemical or Other Material 93
Contamination 45
Appropriate Term/Code Not Available 22
Leak/Splash 16
Difficult to Remove 16
Disconnection 16
Contamination /Decontamination Problem 10
Detachment Of Device Component 10
Insufficient Information 7
Detachment of Device or Device Component 6
Separation Problem 6
Device Markings/Labelling Problem 5
Device Handling Problem 5
Break 4
Positioning Problem 4
Syringe 3
Use of Device Problem 3
Contamination of Device Ingredient or Reagent 3
Particulates 2
Obstruction of Flow 2
Mechanical Problem 2
Delivered as Unsterile Product 2
Device Operates Differently Than Expected 2
Coagulation in Device or Device Ingredient 1
Connector 1
Hub 1
Fungus in Device Environment 1
Tear, Rip or Hole in Device Packaging 1
Packaging Problem 1
Component Falling 1
Product Quality Problem 1
Shelf Life Exceeded 1
Failure to Align 1
Patient-Device Incompatibility 1
Human-Device Interface Problem 1
Device Emits Odor 1
Therapy Delivered to Incorrect Body Area 1
Burst Container or Vessel 1
Cannula 1
Improper or Incorrect Procedure or Method 1
No Apparent Adverse Event 1
Material Opacification 1
Device Packaging Compromised 1
Component Missing 1
Unsealed Device Packaging 1
Total Device Problems 488

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc. (AMO) II May-10-2017
2 Johnson & Johnson Surgical Vision Inc II Jan-27-2020

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