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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)
2019 2020 2021 2022 2023 2024
1 3 2 2 2 3

MDR Year MDR Reports MDR Events
2019 4 4
2020 7 7
2021 6 6
2022 3 3
2023 13 13
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Insufficient Information 9 9
Use of Device Problem 3 3
Patient-Device Incompatibility 2 2
Device Fell 2 2
Contamination 2 2
Device Handling Problem 2 2
Optical Obstruction 2 2
Improper or Incorrect Procedure or Method 2 2
Off-Label Use 1 1
Unintended Movement 1 1
Misassembly During Maintenance/Repair 1 1
Lack of Effect 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 24 24
Dry Eye(s) 14 14
Halo 12 12
Depression 7 7
Pain 6 6
Keratitis 5 5
Suicidal Ideation 5 5
Blurred Vision 5 5
Loss of Vision 5 5
Eye Pain 5 5
Vitreous Floaters 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Discomfort 3 3
Unspecified Eye / Vision Problem 3 3
Insufficient Information 3 3
Unspecified Infection 2 2
Emotional Changes 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Visual Disturbances 2 2
Nerve Damage 2 2
Eye Injury 2 2
Corneal Edema 2 2
Anxiety 2 2
Flashers 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Abscess 1 1
Headache 1 1
Corneal Scar 1 1
Neuralgia 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec, Inc. II Dec-13-2019
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