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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 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 9 9
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
Calibration Problem 1 1
Misassembly During Maintenance/Repair 1 1
Device Fell 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 22 22
Dry Eye(s) 12 12
Halo 9 9
Loss of Vision 5 5
Keratitis 5 5
Pain 5 5
Blurred Vision 4 4
Depression 4 4
Unspecified Eye / Vision Problem 3 3
Insufficient Information 3 3
Vitreous Floaters 3 3
Unspecified Infection 2 2
Eye Injury 2 2
Corneal Edema 2 2
Nerve Damage 2 2
Visual Disturbances 2 2
Anxiety 2 2
Discomfort 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Suicidal Ideation 2 2
Eye Pain 2 2
Neuralgia 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Increased Sensitivity 1 1
Corneal Scar 1 1
Abscess 1 1
Headache 1 1

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