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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 239 415

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 661 666
Decrease in Suction 361 738
Failure to Align 302 302
Failure to Cut 70 70
Insufficient Information 69 69
Appropriate Term/Code Not Available 58 58
Suction Problem 50 192
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
Improper or Incorrect Procedure or Method 14 14
Device Displays Incorrect Message 13 13
Physical Resistance/Sticking 13 13
Patient Device Interaction Problem 11 11
Inadequacy of Device Shape and/or Size 11 11
Output Problem 10 10
Gas/Air Leak 10 10
Computer Software Problem 10 10
Energy Output Problem 10 10
Positioning Problem 9 9
Use of Device Problem 8 8
Unexpected Therapeutic Results 8 8
Mechanical Problem 8 8
Material Integrity Problem 7 7
Defective Device 7 7
Material Split, Cut or Torn 7 7
Failure to Sense 7 7
Unsealed Device Packaging 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Patient-Device Incompatibility 6 6
Malposition of Device 6 6
Break 6 6
Computer System Security Problem 6 6
Difficult to Open or Close 6 6
Image Display Error/Artifact 5 5
Unexpected Shutdown 5 5
Firing Problem 5 5
Display or Visual Feedback Problem 5 5
Contamination 5 5
Mechanics Altered 4 4
Material Deformation 4 4
Detachment of Device or Device Component 4 4
Increase in Pressure 4 4
Device Difficult to Setup or Prepare 4 4
Gradient Increase 4 4
Radiofrequency Interference (RFI) 4 4
Material Rupture 3 3
Device Difficult to Maintain 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 439 443
No Known Impact Or Consequence To Patient 335 335
No Clinical Signs, Symptoms or Conditions 323 700
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 226 226
Insufficient Information 196 196
No Code Available 129 130
No Consequences Or Impact To Patient 65 207
Vitrectomy 65 65
Eye Injury 47 47
Corneal Perforation 45 45
Visual Impairment 24 24
Tissue Damage 23 23
Corneal Edema 20 20
Rupture 19 19
Keratitis 18 18
Macular Edema 16 16
Blurred Vision 14 14
Vitreous Loss 12 12
Wound Dehiscence 12 12
Adhesion(s) 12 12
No Information 11 11
Zonular Dehiscence 11 11
Injury 10 10
Visual Disturbances 10 10
Pain 10 10
Patient Problem/Medical Problem 9 9
Intraocular Pressure Increased 9 9
Inflammation 9 9
Complaint, Ill-Defined 7 7
Dry Eye(s) 7 7
Laceration(s) 7 7
Retinal Detachment 6 6
Discomfort 6 6
Excessive Tear Production 6 6
Perforation 6 6
Corneal Abrasion 6 6
Hemorrhage/Bleeding 6 6
Corneal Scar 5 5
Halo 5 5
Unspecified Eye / Vision Problem 5 5
Hyphema 5 5
Edema 4 5
Vascular Dissection 4 4
Loss of Vision 4 4
Fluid Discharge 4 4
Erosion 4 4
Vitreous Detachment 4 4
No Patient Involvement 4 4
Impaired Healing 4 4
Prolapse 3 3

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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