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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 158
Device Contamination with Chemical or Other Material 146
Break 123
Positioning Failure 66
Difficult or Delayed Positioning 61
Material Deformation 57
Appropriate Term/Code Not Available 45
Split 31
Adverse Event Without Identified Device or Use Problem 27
Contamination During Use 26
Bent 23
Device Operates Differently Than Expected 22
Failure to Eject 19
Torn Material 16
Delivery System Failure 12
Scratched Material 12
Material Integrity Problem 12
Deformation Due to Compressive Stress 11
Device Damaged by Another Device 10
Material Fragmentation 8
Material Separation 8
Stretched 7
Premature Activation 7
Material Split, Cut or Torn 7
Defective Device 6
Insufficient Information 5
Material Frayed 5
Failure to Advance 5
Material Twisted / Bent 4
Contamination / decontamination Problem 4
Material Distortion 4
Hole In Material 4
Material Protrusion / Extrusion 4
Injection System 4
Physical Resistance / Sticking 4
Sticking 3
Dent in Material 3
Device Damaged Prior to Use 3
No Apparent Adverse Event 3
IOL (Intraocular Lens) Implant 3
Use of Device Problem 3
Physical Resistance 3
Device Operational Issue 3
Flare or Flash 2
Device Difficult to Setup or Prepare 2
Entrapment of Device 2
Sharp Edges 2
Material Rupture 2
Haptic 2
Mechanical Jam 2
System 2
Device Handling Problem 1
Plunger 1
Material Too Rigid or Stiff 1
Aspiration Issue 1
Positioning Problem 1
Difficult to Insert 1
Difficult to Advance 1
Separation Problem 1
Detachment of Device or device Component 1
Failure to Unfold or Unwrap 1
Inaccurate Delivery 1
Device Slipped 1
Collapse 1
Material Puncture / Hole 1
Melted 1
Component Missing 1
Failure to Deliver 1
Obstruction of Flow 1
Activation, Positioning or Separation Problem 1
Difficult to Open or Close 1
Tip 1
Material Discolored 1
Product Quality Problem 1
Improper or Incorrect Procedure or Method 1
Burst Container or Vessel 1
Fracture 1
Total Device Problems 1029

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

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