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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 2
BAUSCH & LOMB, INC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
RXSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 340 340
2019 271 271
2020 362 362
2021 289 289
2022 492 492
2023 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 373 373
Device Damaged by Another Device 268 268
Crack 261 261
Adverse Event Without Identified Device or Use Problem 219 219
Scratched Material 156 156
Material Split, Cut or Torn 152 152
Break 131 131
Contamination /Decontamination Problem 76 76
Split 48 48
Defective Device 41 41
Physical Resistance/Sticking 41 41
Contamination 34 34
Material Fragmentation 22 22
Burst Container or Vessel 20 20
Failure to Eject 19 19
Use of Device Problem 17 17
Fracture 15 15
No Apparent Adverse Event 15 15
Insufficient Information 14 14
Appropriate Term/Code Not Available 14 14
Failure to Advance 13 13
Material Deformation 13 13
Material Twisted/Bent 13 13
Device Operates Differently Than Expected 12 12
Particulates 12 12
Mechanical Problem 11 11
Difficult to Remove 10 10
Fitting Problem 10 10
Material Separation 10 10
Defective Component 9 9
Activation, Positioning or Separation Problem 9 9
Difficult to Advance 8 8
Mechanical Jam 8 8
Device Handling Problem 8 8
Sticking 7 7
Material Rupture 6 6
Difficult to Insert 6 6
Inaccurate Delivery 6 6
Torn Material 5 5
Detachment of Device or Device Component 4 4
Material Integrity Problem 4 4
Entrapment of Device 4 4
Unintended Ejection 3 3
Detachment Of Device Component 3 3
Malposition of Device 3 3
Ejection Problem 3 3
Deformation Due to Compressive Stress 3 3
Positioning Problem 3 3
Noise, Audible 2 2
Therapeutic or Diagnostic Output Failure 2 2
Folded 2 2
Device Markings/Labelling Problem 2 2
Physical Resistance 2 2
Material Protrusion/Extrusion 2 2
Bent 2 2
Loose or Intermittent Connection 2 2
Product Quality Problem 2 2
Material Too Rigid or Stiff 1 1
Peeled/Delaminated 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Stretched 1 1
Unstable 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Device Damaged Prior to Use 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Melted 1 1
Material Opacification 1 1
Difficult to Fold, Unfold or Collapse 1 1
Biofilm coating in Device 1 1
Complete Blockage 1 1
Premature Discharge of Battery 1 1
Difficult or Delayed Positioning 1 1
No Pressure 1 1
Operating System Becomes Nonfunctional 1 1
Physical Property Issue 1 1
Device Dislodged or Dislocated 1 1
Inappropriate or Unexpected Reset 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Operational Issue 1 1
Contamination of Device Ingredient or Reagent 1 1
Expiration Date Error 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Failure to Deliver 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Patient-Device Incompatibility 1 1
Device Displays Incorrect Message 1 1
Activation Problem 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Pressure Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 557 557
No Known Impact Or Consequence To Patient 513 513
Insufficient Information 390 390
No Consequences Or Impact To Patient 155 155
No Code Available 74 74
Capsular Bag Tear 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Vitrectomy 32 32
Foreign Body In Patient 32 32
Eye Injury 24 24
No Information 18 18
Visual Impairment 15 15
No Patient Involvement 12 12
Failure of Implant 10 10
Corneal Edema 9 9
Inflammation 8 8
Visual Disturbances 8 8
Vitreous Loss 7 7
Foreign Body Sensation in Eye 6 6
Device Embedded In Tissue or Plaque 6 6
Blurred Vision 5 5
Eye Pain 4 4
Corneal Abrasion 4 4
Edema 3 3
Endophthalmitis 3 3
Hemorrhage/Bleeding 3 3
Pain 3 3
Unspecified Eye / Vision Problem 3 3
Toxic Anterior Segment Syndrome (TASS) 2 2
Iritis 2 2
Uveitis 2 2
Vitreous Floaters 2 2
Loss of Vision 2 2
Halo 2 2
Discomfort 1 1
Injury 1 1
Intraocular Pressure Increased 1 1
Increased Sensitivity 1 1
Tissue Damage 1 1
High Blood Pressure/ Hypertension 1 1
Hyphema 1 1
Corneal Decompensation 1 1
Corneal Perforation 1 1
Corneal Scar 1 1
Corneal Touch 1 1
Failure to Anastomose 1 1
Abrasion 1 1
Bacterial Infection 1 1
Conjunctivitis 1 1
Unspecified Tissue Injury 1 1
Zonular Dehiscence 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Rayner Intraocular Lenses Limited II Apr-21-2020
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