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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, guide, intraocular
Regulation Description Intraocular lens guide.
Product CodeKYB
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
STAAR
  SUBSTANTIALLY EQUIVALENT 1
STAAR SURGICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 175
Device Contamination with Chemical or Other Material 146
Break 130
Contamination 82
Positioning Failure 66
Material Deformation 62
Difficult or Delayed Positioning 61
Failure to Eject 54
Appropriate Term/Code Not Available 45
Split 31
Adverse Event Without Identified Device or Use Problem 26
Bent 23
Device Operates Differently Than Expected 22
Torn Material 16
Device Damaged by Another Device 16
Deformation Due to Compressive Stress 12
Material Integrity Problem 12
Scratched Material 12
Delivery System Failure 12
Premature Activation 11
Material Separation 8
Contamination /Decontamination Problem 8
Material Fragmentation 8
Stretched 7
Material Split, Cut or Torn 7
Material Frayed 6
Defective Device 5
Insufficient Information 5
Failure to Advance 5
Material Twisted/Bent 4
Physical Resistance/Sticking 4
Hole In Material 4
Material Distortion 4
Material Protrusion/Extrusion 4
IOL (Intraocular Lens) Implant 3
No Apparent Adverse Event 3
Device Damaged Prior to Use 3
Sticking 3
Dent in Material 3
Material Rupture 2
Mechanical Jam 2
Physical Resistance 2
Mechanical Problem 2
Flare or Flash 2
Haptic 2
Use of Device Problem 2
Difficult to Insert 2
Device Difficult to Setup or Prepare 2
Entrapment of Device 2
Sharp Edges 2
Fracture 1
Component Missing 1
Difficult to Open or Close 1
Device Slipped 1
Improper or Incorrect Procedure or Method 1
Activation, Positioning or SeparationProblem 1
Device Operational Issue 1
Plunger 1
Material Discolored 1
Obstruction of Flow 1
Burst Container or Vessel 1
Collapse 1
Separation Problem 1
Injection System 1
Tip 1
Difficult to Advance 1
Failure to Unfold or Unwrap 1
Misassembled 1
Product Quality Problem 1
Material Too Rigid or Stiff 1
Device Handling Problem 1
Melted 1
Material Puncture/Hole 1
Failure to Deliver 1
Positioning Problem 1
Total Device Problems 1155

Recalls
Manufacturer Recall Class Date Posted
1 Staar Surgical Co. II Jun-14-2016

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