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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 231 379
2024 135 203

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 612 612
Decrease in Suction 353 627
Failure to Align 260 260
Failure to Cut 70 70
Insufficient Information 69 69
Appropriate Term/Code Not Available 58 58
Suction Problem 49 191
Device Operates Differently Than Expected 35 35
Therapeutic or Diagnostic Output Failure 28 28
Unintended Movement 25 25
Suction Failure 16 16
Application Program Freezes, Becomes Nonfunctional 15 15
Physical Resistance/Sticking 13 13
Improper or Incorrect Procedure or Method 13 13
Device Displays Incorrect Message 12 12
Inadequacy of Device Shape and/or Size 11 11
Patient Device Interaction Problem 11 11
Gas/Air Leak 10 10
Output Problem 10 10
Energy Output Problem 10 10
Positioning Problem 9 9
Unexpected Therapeutic Results 8 8
Use of Device Problem 8 8
Mechanical Problem 8 8
Computer Software Problem 7 7
Defective Device 7 7
Failure to Sense 7 7
Unsealed Device Packaging 7 7
Material Split, Cut or Torn 7 7
Material Integrity Problem 7 7
Difficult to Open or Close 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Computer System Security Problem 6 6
Malposition of Device 6 6
Patient-Device Incompatibility 6 6
Break 6 6
Image Display Error/Artifact 5 5
Firing Problem 5 5
Mechanics Altered 4 4
Detachment of Device or Device Component 4 4
Material Deformation 4 4
Unexpected Shutdown 4 4
Display or Visual Feedback Problem 4 4
Gradient Increase 4 4
Radiofrequency Interference (RFI) 4 4
Device Difficult to Setup or Prepare 4 4
Increase in Pressure 4 4
Material Rupture 3 3
Defective Component 3 3
Failure to Deliver Energy 3 3
Contamination 3 3
Operating System Becomes Nonfunctional 3 3
Human-Device Interface Problem 3 3
Device Handling Problem 3 3
Device Difficult to Maintain 3 3
Scratched Material 3 3
Programming Issue 2 2
Protective Measures Problem 2 2
Improper Device Output 2 2
Inadequate User Interface 2 2
Device Sensing Problem 2 2
Overcorrection 2 2
Output below Specifications 2 2
Detachment Of Device Component 2 2
Accessory Incompatible 2 2
Device Alarm System 2 2
Electrical /Electronic Property Problem 2 2
Gas Output Problem 2 2
Fluid/Blood Leak 2 2
Difficult to Insert 2 2
Leak/Splash 2 2
Self-Activation or Keying 2 2
Material Puncture/Hole 2 2
Delivered as Unsterile Product 2 2
Smoking 2 2
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Unstable 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Off-Label Use 1 1
Power Conditioning Problem 1 1
Physical Resistance 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Activation, Positioning or Separation Problem 1 1
Device Tipped Over 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Migration or Expulsion of Device 1 1
Misfocusing 1 1
Poor Quality Image 1 1
Fracture 1 1
Material Fragmentation 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 396 396
No Known Impact Or Consequence To Patient 335 335
No Clinical Signs, Symptoms or Conditions 300 574
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 216 216
Insufficient Information 167 167
No Code Available 129 130
Vitrectomy 65 65
No Consequences Or Impact To Patient 65 207
Eye Injury 47 47
Corneal Perforation 41 41
Tissue Damage 23 23
Visual Impairment 22 22
Corneal Edema 19 19
Rupture 19 19
Keratitis 18 18
Macular Edema 16 16
Blurred Vision 13 13
Vitreous Loss 12 12
Adhesion(s) 12 12
Wound Dehiscence 12 12
Zonular Dehiscence 11 11
No Information 11 11
Pain 10 10
Visual Disturbances 10 10
Injury 10 10
Inflammation 9 9
Intraocular Pressure Increased 9 9
Patient Problem/Medical Problem 9 9
Laceration(s) 7 7
Dry Eye(s) 7 7
Complaint, Ill-Defined 7 7
Discomfort 6 6
Excessive Tear Production 6 6
Retinal Detachment 6 6
Perforation 6 6
Hemorrhage/Bleeding 6 6
Hyphema 5 5
Corneal Scar 5 5
Corneal Abrasion 5 5
Unspecified Eye / Vision Problem 5 5
Fluid Discharge 4 4
Vascular Dissection 4 4
No Patient Involvement 4 4
Vitreous Detachment 4 4
Erosion 4 4
Edema 4 5
Halo 4 4
Impaired Healing 4 4
Retinal Injury 3 3
Uveitis 3 3
Swelling 3 3
Loss of Vision 3 3
Corneal Ulcer 3 3
Vitreous Floaters 3 3
Capsular Contracture 3 3
Corneal Clouding/Hazing 3 3
Red Eye(s) 3 3
Prolapse 3 3
Foreign Body In Patient 3 3
Eye Pain 3 3
Intraocular Pressure Decreased 2 2
Toxic Anterior Segment Syndrome (TASS) 2 2
Cusp Tear 2 2
Headache 2 2
Emotional Changes 2 2
Failure of Implant 2 2
Cataract 2 2
Foreign Body Sensation in Eye 2 2
Vitreous Hemorrhage 2 2
Burning Sensation 2 2
Therapeutic Effects, Unexpected 2 2
Reaction 2 2
Anxiety 2 2
Therapeutic Response, Decreased 1 1
Clouding, Central Corneal 1 1
Corneal Infiltrates 1 1
Collapse 1 1
Fungal Infection 1 1
Depression 1 1
Scarring 1 1
Increased Sensitivity 1 1
Toxemia 1 1
Glaucoma 1 1
Chemosis 1 1
Failure to Anastomose 1 1
Abrasion 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Endophthalmitis 1 1
Pyrosis/Heartburn 1 1
Neuropathy 1 1
Irritation 1 1
Intraocular Infection 1 1
Eye Burn 1 1
Blood Loss 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Suicidal Ideation 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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