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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)
Product CodeMSS
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AST PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAUSCH & LOMB, INC
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
RXSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 2
STAAR SURGICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 114 114
2018 340 340
2019 271 271
2020 362 362
2021 289 289
2022 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 237 237
Adverse Event Without Identified Device or Use Problem 224 224
Device Contamination with Chemical or Other Material 208 208
Scratched Material 148 148
Material Split, Cut or Torn 137 137
Break 129 129
Device Damaged by Another Device 106 106
Contamination /Decontamination Problem 76 76
Split 60 60
Physical Resistance/Sticking 39 39
Contamination 34 34
Burst Container or Vessel 22 22
Material Fragmentation 22 22
Use of Device Problem 17 17
Insufficient Information 17 17
Fracture 15 15
Device Operates Differently Than Expected 14 14
Material Deformation 13 13
Defective Device 13 13
Appropriate Term/Code Not Available 12 12
Difficult to Remove 11 11
Material Separation 10 10
Fitting Problem 10 10
Mechanical Problem 10 10
Particulates 10 10
No Apparent Adverse Event 9 9
Activation, Positioning or SeparationProblem 9 9
Sticking 9 9
Failure to Advance 8 8
Mechanical Jam 8 8
Device Handling Problem 8 8
Torn Material 8 8
Difficult to Advance 7 7
Difficult to Insert 6 6
Failure to Eject 6 6
Material Twisted/Bent 6 6
Defective Component 6 6
Material Integrity Problem 5 5
Inaccurate Delivery 5 5
Detachment of Device or Device Component 4 4
Material Rupture 4 4
Entrapment of Device 4 4
Malposition of Device 3 3
Positioning Problem 3 3
Deformation Due to Compressive Stress 3 3
Detachment Of Device Component 3 3
Improper or Incorrect Procedure or Method 2 2
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Dent in Material 2 2
Material Protrusion/Extrusion 2 2
Physical Resistance 2 2
Folded 2 2
Patient-Device Incompatibility 2 2
Bent 2 2
Device Dislodged or Dislocated 2 2
Therapeutic or Diagnostic Output Failure 2 2
Noise, Audible 2 2
Ejection Problem 2 2
Device Markings/Labelling Problem 2 2
Loose or Intermittent Connection 2 2
Biofilm coating in Device 1 1
Difficult or Delayed Positioning 1 1
Device Damaged Prior to Use 1 1
Device Displays Incorrect Message 1 1
Inappropriate or Unexpected Reset 1 1
Explosion 1 1
Activation Problem 1 1
Physical Property Issue 1 1
Temperature Problem 1 1
Delamination 1 1
Delivery System Failure 1 1
Structural Problem 1 1
Failure to Deliver 1 1
Difficult To Position 1 1
Material Puncture/Hole 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Device Slipped 1 1
Stretched 1 1
Melted 1 1
Unintended Ejection 1 1
Complete Blockage 1 1
Material Too Rigid or Stiff 1 1
Material Opacification 1 1
Off-Label Use 1 1
Device Operational Issue 1 1
Wrinkled 1 1
Expiration Date Error 1 1
Patient Device Interaction Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Fold, Unfold or Collapse 1 1
Peeled/Delaminated 1 1
Unstable 1 1
Vibration 1 1
No Pressure 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 569 569
No Clinical Signs, Symptoms or Conditions 336 336
No Consequences Or Impact To Patient 162 162
Insufficient Information 160 160
No Code Available 77 77
Capsular Bag Tear 74 74
Vitrectomy 50 50
Foreign Body In Patient 33 33
No Information 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Eye Injury 18 18
No Patient Involvement 13 13
Visual Impairment 11 11
Inflammation 10 10
Failure of Implant 10 10
Corneal Edema 10 10
Vitreous Loss 8 8
Visual Disturbances 7 7
Device Embedded In Tissue or Plaque 7 7
Endophthalmitis 6 6
Foreign Body Sensation in Eye 6 6
Pain 5 5
Blurred Vision 3 3
Hemorrhage/Bleeding 3 3
Edema 3 3
Corneal Abrasion 3 3
Unspecified Eye / Vision Problem 3 3
Toxic Anterior Segment Syndrome (TASS) 2 2
Hyphema 2 2
Hypopyon 2 2
Uveitis 2 2
Loss of Vision 2 2
Halo 2 2
Injury 1 1
Reaction 1 1
Rupture 1 1
Increased Sensitivity 1 1
Tissue Damage 1 1
Unspecified Infection 1 1
High Blood Pressure/ Hypertension 1 1
Corneal Decompensation 1 1
Failure to Anastomose 1 1
Abrasion 1 1
Corneal Perforation 1 1
Corneal Touch 1 1
Eye Pain 1 1
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1

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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