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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device eyelid thermal pulsation system
Definition Therapeutic application of heat and massage to the eyelids.
Product CodeORZ
Regulation Number 886.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
SIGHT SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TEAR FILM INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TEARSCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 4 4
2021 2 2
2022 2 2
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Thermal Decomposition of Device 2 2
Delivered as Unsterile Product 2 2
Appropriate Term/Code Not Available 2 2
Output Problem 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Unsealed Device Packaging 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Pain 4 4
Red Eye(s) 3 3
Keratitis 3 3
Insufficient Information 3 3
Vitreous Floaters 3 3
Unspecified Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Corneal Abrasion 2 2
Eye Infections 2 2
Corneal Infiltrates 2 2
Iritis 1 1
Arthralgia 1 1
Vitreous Detachment 1 1
Fatigue 1 1
Dry Eye(s) 1 1
Inflammation 1 1
Corneal Ulcer 1 1
Flashers 1 1
Rash 1 1
No Patient Involvement 1 1
Unspecified Eye / Vision Problem 1 1
Visual Impairment 1 1
Eye Injury 1 1
Corneal Edema 1 1
Cough 1 1
Blurred Vision 1 1
Erosion 1 1
Loss of Vision 1 1
Eye Pain 1 1
Bruise/Contusion 1 1
Excessive Tear Production 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sight Sciences, Inc. II Apr-25-2022
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