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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
1 2 1 3 2 0

MDR Year MDR Reports MDR Events
2017 6 6
2018 8 8
2019 4 4
2020 7 7
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Insufficient Information 6 6
Device Handling Problem 2 2
Optical Obstruction 2 2
Contamination 2 2
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Application Program Problem 1 1
Calibration Problem 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1
Application Program Problem: Parameter Calculation Error 1 1
Off-Label Use 1 1
Output Problem 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 12 12
Dry Eye(s) 10 10
Halo 7 7
Blurred Vision 5 5
Pain 4 4
Keratitis 4 4
Vitreous Floaters 3 3
No Code Available 3 3
Visual Disturbances 3 3
Unspecified Eye / Vision Problem 3 3
Insufficient Information 2 2
Eye Injury 2 2
Unspecified Infection 2 2
Loss of Vision 2 2
Anxiety 2 2
Discomfort 2 2
Depression 1 1
Foreign Body In Patient 1 1
Not Applicable 1 1
Tissue Damage 1 1
Abscess 1 1
Nausea 1 1
Nerve Damage 1 1
Headache 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Increased Sensitivity 1 1
Burning Sensation 1 1
Neuralgia 1 1
Suicidal Ideation 1 1
Eye Pain 1 1

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