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TPLC
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Device
eyelid thermal pulsation system
Definition
Therapeutic application of heat and massage to the eyelids.
Product Code
ORZ
Regulation Number
886.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Appropriate Term/Code Not Available
2
2
Delivered as Unsterile Product
2
2
Unexpected Therapeutic Results
1
1
Insufficient Information
1
1
Patient-Device Incompatibility
1
1
Output Problem
1
1
Unsealed Device Packaging
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
Rash
1
1
Flashers
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
Excessive Tear Production
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sight Sciences, Inc.
II
Apr-25-2022
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