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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
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMO MANUFACTURING USA, LLC
  SUBSTANTIALLY EQUIVALENT 4
AMO MANUFACTURNG USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
LENSAR, INC.
  SUBSTANTIALLY EQUIVALENT 4
SIE AG, SURGICAL INSTRUMENT ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
TECHNOLAS PERFECT VISION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 434 434
2019 311 344
2020 199 280
2021 328 356
2022 204 262
2023 79 111

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 528 528
Decrease in Suction 314 404
Failure to Align 178 178
Insufficient Information 68 68
Failure to Cut 67 67
Suction Problem 44 186
Appropriate Term/Code Not Available 36 36
Device Operates Differently Than Expected 35 35
Therapeutic or Diagnostic Output Failure 26 26
Unintended Movement 22 22
Physical Resistance/Sticking 13 13
Suction Failure 13 13
Device Displays Incorrect Message 11 11
Inadequacy of Device Shape and/or Size 11 11
Improper or Incorrect Procedure or Method 10 10
Gas/Air Leak 10 10
Output Problem 10 10
Positioning Problem 9 9
Patient Device Interaction Problem 8 8
Unexpected Therapeutic Results 8 8
Mechanical Problem 7 7
Unsealed Device Packaging 7 7
Material Split, Cut or Torn 7 7
Material Integrity Problem 7 7
Break 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Failure to Sense 6 6
Difficult to Open or Close 6 6
Computer System Security Problem 6 6
Malposition of Device 6 6
Patient-Device Incompatibility 6 6
Defective Device 6 6
Use of Device Problem 5 5
Increase in Pressure 4 4
Gradient Increase 4 4
Mechanics Altered 4 4
Detachment of Device or Device Component 4 4
Material Deformation 4 4
Firing Problem 4 4
Unexpected Shutdown 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Energy Output Problem 3 3
Computer Software Problem 3 3
Defective Component 3 3
Material Rupture 3 3
Self-Activation or Keying 2 2
Material Puncture/Hole 2 2
Smoking 2 2
Device Sensing Problem 2 2
Device Alarm System 2 2
Detachment Of Device Component 2 2
Display or Visual Feedback Problem 2 2
Electrical /Electronic Property Problem 2 2
Delivered as Unsterile Product 2 2
Image Display Error/Artifact 2 2
Difficult to Insert 2 2
Leak/Splash 2 2
Fluid/Blood Leak 2 2
Gas Output Problem 2 2
Improper Device Output 2 2
Inadequate User Interface 2 2
Overcorrection 2 2
Programming Issue 2 2
Protective Measures Problem 2 2
Output below Specifications 2 2
Scratched Material 1 1
Temperature Problem 1 1
Physical Property Issue 1 1
Operating System Becomes Nonfunctional 1 1
Optical Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Moisture or Humidity Problem 1 1
Activation Problem 1 1
Separation Problem 1 1
Air/Gas in Device 1 1
Migration 1 1
Noise, Audible 1 1
Power Problem 1 1
Air Leak 1 1
Fracture 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
Off-Label Use 1 1
Power Conditioning Problem 1 1
Device Difficult to Setup or Prepare 1 1
Fire 1 1
Component Falling 1 1
Component Incompatible 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
Material Disintegration 1 1
No Display/Image 1 1
Signal Artifact/Noise 1 1
Complete Blockage 1 1
Contamination 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 335 335
Capsular Bag Tear 323 323
No Clinical Signs, Symptoms or Conditions 234 324
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 166 166
No Code Available 129 130
Insufficient Information 92 92
Vitrectomy 65 65
No Consequences Or Impact To Patient 65 207
Eye Injury 45 45
Corneal Perforation 29 29
Tissue Damage 23 23
Rupture 19 19
Keratitis 18 18
Corneal Edema 17 17
Visual Impairment 17 17
Macular Edema 14 14
Adhesion(s) 11 11
Vitreous Loss 11 11
No Information 11 11
Zonular Dehiscence 10 10
Injury 10 10
Wound Dehiscence 10 10
Pain 9 9
Visual Disturbances 9 9
Patient Problem/Medical Problem 9 9
Inflammation 8 8
Intraocular Pressure Increased 7 7
Laceration(s) 7 7
Complaint, Ill-Defined 7 7
Perforation 6 6
Dry Eye(s) 6 6
Blurred Vision 6 6
Discomfort 6 6
Excessive Tear Production 6 6
Corneal Abrasion 5 5
Erosion 4 4
Edema 4 5
Hemorrhage/Bleeding 4 4
Impaired Healing 4 4
Halo 4 4
Fluid Discharge 4 4
No Patient Involvement 4 4
Vascular Dissection 4 4
Foreign Body In Patient 3 3
Loss of Vision 3 3
Swelling 3 3
Vitreous Detachment 3 3
Corneal Clouding/Hazing 3 3
Red Eye(s) 3 3
Retinal Detachment 3 3
Corneal Scar 3 3
Corneal Ulcer 3 3
Capsular Contracture 3 3
Emotional Changes 2 2
Headache 2 2
Foreign Body Sensation in Eye 2 2
Hyphema 2 2
Failure of Implant 2 2
Prolapse 2 2
Reaction 2 2
Anxiety 2 2
Therapeutic Effects, Unexpected 2 2
Uveitis 2 2
Burning Sensation 2 2
Cusp Tear 2 2
Eye Pain 2 2
Intraocular Pressure Decreased 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Unspecified Eye / Vision Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Vitreous Hemorrhage 1 1
Clouding, Central Corneal 1 1
Corneal Infiltrates 1 1
Depression 1 1
Therapeutic Response, Decreased 1 1
Toxemia 1 1
Collapse 1 1
Fungal Infection 1 1
Eye Burn 1 1
Blood Loss 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Glaucoma 1 1
Pyrosis/Heartburn 1 1
Scarring 1 1
Increased Sensitivity 1 1
Neuropathy 1 1
Irritation 1 1
Endophthalmitis 1 1
Vitreous Floaters 1 1
Cataract 1 1
Chemosis 1 1
Failure to Anastomose 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Dec-29-2021
2 Johnson & Johnson Surgical Vision Inc II Oct-03-2018
3 SIE AG, Surgical Instrument Engineering II Mar-29-2018
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