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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device femtosecond laser system for refractive correction
Definition Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea
Product CodeOTL
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
2 2 2 5 3 0

MDR Year MDR Reports MDR Events
2021 6 6
2022 3 3
2023 13 14
2024 11 11
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 12
Insufficient Information 5 5
Use of Device Problem 5 5
Patient-Device Incompatibility 3 3
Device Fell 2 2
Improper or Incorrect Procedure or Method 2 2
Off-Label Use 1 1
Unintended Movement 1 1
Contamination 1 1
Patient Device Interaction Problem 1 1
Lack of Effect 1 1
Device Handling Problem 1 1
Optical Obstruction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 24 24
Dry Eye(s) 14 15
Halo 10 11
Depression 7 7
Loss of Vision 7 7
Suicidal Ideation 5 5
Blurred Vision 5 5
Eye Pain 5 5
Pain 4 4
Emotional Changes 3 3
Visual Disturbances 3 3
Burning Sensation 3 3
Unspecified Eye / Vision Problem 3 3
Insufficient Information 3 3
Discomfort 3 3
Vitreous Floaters 3 3
Increased Sensitivity 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Keratitis 2 2
Nerve Damage 2 2
Eye Injury 2 2
Corneal Edema 2 2
Foreign Body Sensation in Eye 1 1
Flashers 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Anxiety 1 1
Headache 1 1
Neuralgia 1 1
Corneal Scar 1 1

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