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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 239 415

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 545 550
Failure to Align 302 302
Decrease in Suction 270 647
Appropriate Term/Code Not Available 46 46
Suction Problem 39 181
Failure to Cut 38 38
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
Patient Device Interaction Problem 11 11
Physical Resistance/Sticking 11 11
Inadequacy of Device Shape and/or Size 10 10
Computer Software Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Energy Output Problem 9 9
Use of Device Problem 8 8
Mechanical Problem 7 7
Positioning Problem 7 7
Failure to Sense 7 7
Output Problem 7 7
Device Displays Incorrect Message 7 7
Unsealed Device Packaging 6 6
Computer System Security Problem 6 6
Defective Device 5 5
Difficult to Open or Close 5 5
Unexpected Therapeutic Results 5 5
Contamination 5 5
Unexpected Shutdown 5 5
Patient-Device Incompatibility 4 4
Image Display Error/Artifact 4 4
Gas/Air Leak 4 4
Device Difficult to Setup or Prepare 4 4
Malposition of Device 4 4
Gradient Increase 4 4
Radiofrequency Interference (RFI) 4 4
Firing Problem 4 4
Increase in Pressure 4 4
Display or Visual Feedback Problem 4 4
Defective Component 3 3
Device Difficult to Maintain 3 3
Failure to Deliver Energy 3 3
Mechanics Altered 3 3
Operating System Becomes Nonfunctional 3 3
Material Deformation 3 3
Device Handling Problem 3 3
Material Split, Cut or Torn 3 3
Break 2 2
Scratched Material 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 364 368
No Clinical Signs, Symptoms or Conditions 323 700
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 226 226
Insufficient Information 196 196
No Known Impact Or Consequence To Patient 156 156
No Code Available 78 78
Corneal Perforation 44 44
Vitrectomy 38 38
No Consequences Or Impact To Patient 36 178
Corneal Edema 18 18
Visual Impairment 17 17
Tissue Damage 15 15
Eye Injury 15 15
Macular Edema 15 15
Keratitis 15 15
Blurred Vision 14 14
Wound Dehiscence 12 12
Rupture 11 11
Visual Disturbances 9 9
Zonular Dehiscence 9 9
Patient Problem/Medical Problem 8 8
Vitreous Loss 8 8
No Information 7 7
Dry Eye(s) 7 7
Hemorrhage/Bleeding 6 6
Inflammation 6 6
Adhesion(s) 6 6
Corneal Scar 5 5
Hyphema 5 5
Injury 5 5
Intraocular Pressure Increased 5 5
Retinal Detachment 5 5
Unspecified Eye / Vision Problem 5 5
Pain 5 5
Laceration(s) 5 5
Corneal Abrasion 4 4
No Patient Involvement 4 4
Fluid Discharge 4 4
Perforation 3 3
Uveitis 3 3
Corneal Clouding/Hazing 3 3
Eye Pain 3 3
Loss of Vision 3 3
Retinal Injury 3 3
Vitreous Floaters 3 3
Vitreous Detachment 3 3
Capsular Contracture 3 3
Halo 3 3
Excessive Tear Production 2 2
Headache 2 2

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