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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, INC.
  SUBSTANTIALLY EQUIVALENT 4
STAAR
  SUBSTANTIALLY EQUIVALENT 1
STAAR SURGICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 292
Torn Material 21
Insufficient Information 10
Device Operates Differently Than Expected 8
Break 8
Mechanical Jam 7
Device Handling Problem 7
Split 6
Difficult to Insert 5
Bent 5
Mechanical Problem 5
Use of Device Problem 5
Activation, Positioning or Separation Problem 4
Device Contamination with Chemical or Other Material 4
Difficult to Advance 3
Haptic 3
Detachment Of Device Component 3
No Apparent Adverse Event 3
Material Split, Cut or Torn 2
Loose or Intermittent Connection 2
Kinked 1
Component Falling 1
Crack 1
Difficult or Delayed Positioning 1
Positioning Failure 1
Fracture 1
Device Damaged Prior to Use 1
Component Missing 1
Device Issue 1
Expiration Date Error 1
Material Opacification 1
Particulates 1
Material Too Rigid or Stiff 1
Material Rupture 1
Device Slipped 1
Sticking 1
Tip 1
Scratched Material 1
Material Protrusion / Extrusion 1
Detachment of Device or device Component 1
Device Markings / Labelling Problem 1
Device Operational Issue 1
Device Damaged by Another Device 1
Defective Device 1
Wrinkled 1
Malposition of device 1
Contamination of Device Ingredient or Reagent 1
Delamination 1
Delivery System Failure 1
Failure to Eject 1
Appropriate Term/Code Not Available 1
Total Device Problems 434

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
4 Rayner Intraocular Lenses Limited II Apr-21-2020

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