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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
MEDICEL AG
  SUBSTANTIALLY EQUIVALENT 1
RXSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 271 271
2020 362 362
2021 289 289
2022 490 490
2023 330 330
2024 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 406 406
Device Contamination with Chemical or Other Material 386 386
Adverse Event Without Identified Device or Use Problem 230 230
Crack 199 199
Material Split, Cut or Torn 145 145
Scratched Material 140 140
Break 92 92
Contamination /Decontamination Problem 73 73
Defective Device 59 59
Failure to Eject 46 46
Physical Resistance/Sticking 36 36
Contamination 31 31
Material Fragmentation 22 22
No Apparent Adverse Event 22 22
Insufficient Information 18 18
Material Twisted/Bent 18 18
Use of Device Problem 18 18
Defective Component 17 17
Appropriate Term/Code Not Available 17 17
Failure to Advance 16 16
Particulates 15 15
Fracture 13 13
Mechanical Problem 10 10
Material Separation 10 10
Difficult to Advance 10 10
Activation, Positioning or Separation Problem 9 9
Difficult to Remove 8 8
Burst Container or Vessel 8 8
Device Handling Problem 7 7
Inaccurate Delivery 6 6
Material Rupture 5 5
Unintended Ejection 5 5
Ejection Problem 5 5
Mechanical Jam 5 5
Entrapment of Device 4 4
Difficult to Insert 3 3
Off-Label Use 3 3
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Deformation Due to Compressive Stress 3 3
Material Protrusion/Extrusion 2 2
Device Markings/Labelling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Noise, Audible 2 2
Fitting Problem 2 2
Product Quality Problem 2 2
Material Too Rigid or Stiff 1 1
Inadequacy of Device Shape and/or Size 1 1
Stretched 1 1
Unstable 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Failure to Deliver 1 1
Material Puncture/Hole 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Difficult or Delayed Positioning 1 1
Complete Blockage 1 1
Premature Discharge of Battery 1 1
Biofilm coating in Device 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Activation Problem 1 1
No Pressure 1 1
Operating System Becomes Nonfunctional 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Expiration Date Error 1 1
Malposition of Device 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 706 706
Insufficient Information 534 534
No Known Impact Or Consequence To Patient 286 286
No Consequences Or Impact To Patient 106 106
Capsular Bag Tear 61 61
No Code Available 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Eye Injury 32 32
Foreign Body In Patient 30 30
Vitrectomy 26 26
Visual Impairment 17 17
Visual Disturbances 10 10
Corneal Edema 10 10
Vitreous Loss 7 7
Failure of Implant 7 7
Foreign Body Sensation in Eye 6 6
Blurred Vision 6 6
No Information 5 5
Inflammation 5 5
No Patient Involvement 5 5
Corneal Abrasion 4 4
Device Embedded In Tissue or Plaque 4 4
Eye Pain 4 4
Unspecified Eye / Vision Problem 3 3
Edema 3 3
Hemorrhage/Bleeding 3 3
Endophthalmitis 3 3
Uveitis 2 2
Iritis 2 2
Vitreous Floaters 2 2
Halo 2 2
Toxic Anterior Segment Syndrome (TASS) 2 2
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1
Unspecified Tissue Injury 1 1
Discomfort 1 1
Injury 1 1
Intraocular Pressure Increased 1 1
Pain 1 1
Increased Sensitivity 1 1
High Blood Pressure/ Hypertension 1 1
Hyphema 1 1
Macular Edema 1 1
Corneal Decompensation 1 1
Corneal Perforation 1 1
Corneal Scar 1 1
Corneal Touch 1 1
Failure to Anastomose 1 1
Wound Dehiscence 1 1
Abrasion 1 1
Bacterial Infection 1 1
Conjunctivitis 1 1

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