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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ophthalmic femtosecond laser
Definition Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Product CodeOOE
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
AMO MANUFACTURING USA, LLC
  SUBSTANTIALLY EQUIVALENT 3
AMO MANUFACTURNG USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
LENSAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIE AG, SURGICAL INSTRUMENT ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
TECHNOLAS PERFECT VISION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 311 344
2020 199 280
2021 328 356
2022 204 262
2023 231 379
2024 193 305

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 522 527
Failure to Align 284 284
Decrease in Suction 267 580
Appropriate Term/Code Not Available 46 46
Failure to Cut 38 38
Suction Problem 38 180
Therapeutic or Diagnostic Output Failure 28 28
Insufficient Information 20 20
Unintended Movement 20 20
Application Program Freezes, Becomes Nonfunctional 15 15
Suction Failure 14 14
Physical Resistance/Sticking 11 11
Patient Device Interaction Problem 11 11
Inadequacy of Device Shape and/or Size 10 10
Improper or Incorrect Procedure or Method 9 9
Energy Output Problem 9 9
Use of Device Problem 8 8
Failure to Sense 7 7
Mechanical Problem 7 7
Output Problem 7 7
Computer Software Problem 7 7
Positioning Problem 7 7
Unsealed Device Packaging 6 6
Computer System Security Problem 6 6
Device Displays Incorrect Message 6 6
Difficult to Open or Close 5 5
Unexpected Therapeutic Results 5 5
Defective Device 5 5
Firing Problem 4 4
Malposition of Device 4 4
Unexpected Shutdown 4 4
Image Display Error/Artifact 4 4
Contamination 4 4
Patient-Device Incompatibility 4 4
Gas/Air Leak 4 4
Radiofrequency Interference (RFI) 4 4
Device Difficult to Setup or Prepare 4 4
Gradient Increase 4 4
Increase in Pressure 4 4
Device Difficult to Maintain 3 3
Material Split, Cut or Torn 3 3
Operating System Becomes Nonfunctional 3 3
Defective Component 3 3
Material Deformation 3 3
Device Handling Problem 3 3
Failure to Deliver Energy 3 3
Mechanics Altered 3 3
Display or Visual Feedback Problem 3 3
Break 2 2
Material Rupture 2 2
Scratched Material 2 2
Difficult to Insert 2 2
Device Alarm System 2 2
Accessory Incompatible 2 2
Material Integrity Problem 2 2
Device Sensing Problem 2 2
Human-Device Interface Problem 2 2
Gas Output Problem 2 2
Smoking 2 2
Delivered as Unsterile Product 2 2
Electrical /Electronic Property Problem 2 2
Contamination /Decontamination Problem 1 1
Self-Activation or Keying 1 1
Signal Artifact/Noise 1 1
Deformation Due to Compressive Stress 1 1
Material Puncture/Hole 1 1
Device Tipped Over 1 1
Activation Problem 1 1
Activation, Positioning or Separation Problem 1 1
Overcorrection 1 1
Incorrect Measurement 1 1
Material Disintegration 1 1
Fire 1 1
Failure to Cycle 1 1
Product Quality Problem 1 1
Migration 1 1
Unstable 1 1
Power Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Pressure Problem 1 1
Air/Gas in Device 1 1
Leak/Splash 1 1
Contamination of Device Ingredient or Reagent 1 1
Optical Problem 1 1
Poor Quality Image 1 1
Complete Blockage 1 1
Positioning Failure 1 1
Inadequate or Insufficient Training 1 1
Application Program Problem 1 1
Protective Measures Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device Damaged Prior to Use 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Loose or Intermittent Connection 1 1
Misfocusing 1 1
Separation Problem 1 1
Noise, Audible 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequate User Interface 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 345 349
No Clinical Signs, Symptoms or Conditions 312 625
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 222 222
Insufficient Information 185 185
No Known Impact Or Consequence To Patient 156 156
No Code Available 78 78
Corneal Perforation 41 41
Vitrectomy 38 38
No Consequences Or Impact To Patient 36 178
Corneal Edema 17 17
Visual Impairment 16 16
Tissue Damage 15 15
Keratitis 15 15
Macular Edema 15 15
Eye Injury 15 15
Blurred Vision 13 13
Wound Dehiscence 12 12
Rupture 11 11
Visual Disturbances 9 9
Zonular Dehiscence 9 9
Vitreous Loss 8 8
Patient Problem/Medical Problem 8 8
Dry Eye(s) 7 7
No Information 7 7
Adhesion(s) 6 6
Hemorrhage/Bleeding 6 6
Inflammation 6 6
Intraocular Pressure Increased 5 5
Laceration(s) 5 5
Pain 5 5
Hyphema 5 5
Corneal Scar 5 5
Injury 5 5
Retinal Detachment 5 5
Unspecified Eye / Vision Problem 5 5
Fluid Discharge 4 4
No Patient Involvement 4 4
Vitreous Detachment 3 3
Retinal Injury 3 3
Uveitis 3 3
Loss of Vision 3 3
Halo 3 3
Vitreous Floaters 3 3
Capsular Contracture 3 3
Corneal Abrasion 3 3
Corneal Clouding/Hazing 3 3
Perforation 3 3
Eye Pain 3 3
Intraocular Pressure Decreased 2 2
Toxic Anterior Segment Syndrome (TASS) 2 2
Vascular Dissection 2 2
Headache 2 2
Emotional Changes 2 2
Failure of Implant 2 2
Cataract 2 2
Corneal Ulcer 2 2
Vitreous Hemorrhage 2 2
Swelling 2 2
Prolapse 2 2
Discomfort 2 2
Excessive Tear Production 2 2
Cusp Tear 2 2
Foreign Body In Patient 2 2
Impaired Healing 2 2
Therapeutic Response, Decreased 1 1
Anxiety 1 1
Blood Loss 1 1
Depression 1 1
Therapeutic Effects, Unexpected 1 1
Toxemia 1 1
Clouding, Central Corneal 1 1
Corneal Infiltrates 1 1
Edema 1 1
Foreign Body Sensation in Eye 1 1
Glaucoma 1 1
Failure to Anastomose 1 1
Erosion 1 1
Abrasion 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Endophthalmitis 1 1
Intraocular Infection 1 1
Suicidal Ideation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Dec-29-2021
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