TPLC - Total Product Life Cycle

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Device	eyelid thermal pulsation system
Regulation Description	Eyelid thermal pulsation system.
Definition	Therapeutic application of heat and massage to the eyelids.
Product Code	ORZ
Regulation Number	886.5200
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9	9
Appropriate Term/Code Not Available	2	2
Output Problem	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Thermal Decomposition of Device	1	1
Delivered as Unsterile Product	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	3	3
Pain	3	3
Vitreous Floaters	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Known Impact Or Consequence To Patient	2	2
Eye Infections	2	2
Arthralgia	1	1
Vitreous Detachment	1	1
Fatigue	1	1
Corneal Abrasion	1	1
Dry Eye(s)	1	1
Inflammation	1	1
Corneal Ulcer	1	1
Skin Discoloration	1	1
Flashers	1	1
Rash	1	1
Unspecified Eye / Vision Problem	1	1
Visual Impairment	1	1
Eye Injury	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