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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)
2017 2018 2019 2020 2021 2022 2023 2024
1 2 1 3 2 2 2 2

MDR Year MDR Reports MDR Events
2017 6 6
2018 8 8
2019 4 4
2020 7 7
2021 6 6
2022 3 3
2023 13 13
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 19 19
Insufficient Information 10 10
Use of Device Problem 3 3
Optical Obstruction 2 2
Contamination 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Device Handling Problem 2 2
Off-Label Use 1 1
Application Program Problem 1 1
Calibration Problem 1 1
Output Problem 1 1
Misassembly During Maintenance/Repair 1 1
Device Operates Differently Than Expected 1 1
Application Program Problem: Parameter Calculation Error 1 1
Device Fell 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 25 25
Dry Eye(s) 15 15
Halo 10 10
Blurred Vision 6 6
Loss of Vision 6 6
Pain 5 5
Keratitis 5 5
Eye Injury 4 4
Vitreous Floaters 4 4
Depression 4 4
No Code Available 3 3
Unspecified Eye / Vision Problem 3 3
Insufficient Information 3 3
Visual Disturbances 3 3
Nerve Damage 2 2
Headache 2 2
Unspecified Infection 2 2
Corneal Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Suicidal Ideation 2 2
Eye Pain 2 2
Anxiety 2 2
Discomfort 2 2
Foreign Body In Patient 1 1
Not Applicable 1 1
Neuralgia 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Increased Sensitivity 1 1
Corneal Scar 1 1
Nausea 1 1
Abscess 1 1
Tissue Damage 1 1
Burning Sensation 1 1

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