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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device folders and injectors, intraocular lens (iol)
Regulation Description Intraocular lens guide.
Product CodeMSS
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL OPTICS INC
  SUBSTANTIALLY EQUIVALENT 1
AST PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAUSCH & LOMB
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 5
RAYNER
  SUBSTANTIALLY EQUIVALENT 3
RAYNER & KEELER LTD.
  SUBSTANTIALLY EQUIVALENT 3
STAAR
  SUBSTANTIALLY EQUIVALENT 1
STAAR SURGICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 365
Torn Material 22
Break 9
Device Operates Differently Than Expected 8
Mechanical Jam 7
Detachment Of Device Component 6
Split 6
Activation, Positioning or Separation Problem 6
Bent 5
Difficult to Insert 5
Device Contamination with Chemical or Other Material 4
Device Handling Problem 4
Use of Device Problem 4
No Apparent Adverse Event 3
Haptic 3
Difficult to Advance 3
Mechanical Problem 3
Delivery System Failure 2
Loose or Intermittent Connection 2
Material Rupture 1
Device Damaged Prior to Use 1
Malposition of device 1
Scratched Material 1
Kinked 1
Component Falling 1
Detachment of Device or device Component 1
Defective Device 1
Device Slipped 1
Crack 1
Insufficient Information 1
Sticking 1
Contamination of Device Ingredient or Reagent 1
Positioning Failure 1
Material Opacification 1
Material Too Rigid or Stiff 1
Device Issue 1
Device Damaged by Another Device 1
Material Protrusion / Extrusion 1
Appropriate Term/Code Not Available 1
Material Split, Cut or Torn 1
Particulates 1
Component Missing 1
Delamination 1
Tip 1
Difficult or Delayed Positioning 1
Wrinkled 1
Device Operational Issue 1
Failure to Advance 1
Total Device Problems 496

Recalls
Manufacturer Recall Class Date Posted
1 Aaren Scientific Inc. II Nov-08-2017
2 Alcon Research, Ltd. II Jan-09-2017
3 Bausch & Lomb Surgical, Inc. II May-16-2017

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