TPLC - Total Product Life Cycle

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Device	products, contact lens care, rigid gas permeable
Regulation Description	Rigid gas permeable contact lens care products.
Product Code	MRC
Regulation Number	886.5918
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15	15
Microbial Contamination of Device	8	8
Break	2	2
Material Disintegration	2	2
Material Integrity Problem	2	2
Insufficient Device Problem Information	2	2
Contamination of Device Ingredient or Reagent	2	2
Patient Device Interaction Problem	1	1
Delivered as Unsterile Product	1	1
Product Quality Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Eye Infections	40	44
Red Eye(s)	27	27
Eye Pain	23	23
Eye Irritation	17	17
Corneal Ulcer	14	14
Tissue Irritation	12	12
Visual Impairment	9	9
Discomfort	8	8
Conjunctivitis	7	7
Corneal Scar	6	6
Blurred Vision	6	10
Pain	6	6
Bacterial Infection	5	5
Inflammation	5	5
Burning Sensation	5	5
Corneal Edema	4	4
Corneal Abrasion	4	4
Dry Eye(s)	4	8
Itching Sensation	4	4
Swelling/ Edema	3	3
Eye Injury	3	4
Insufficient Information	3	3
Eye Burn	3	3
Unspecified Infection	3	3
Skin Inflammation/ Irritation	2	3
Hypersensitivity/Allergic reaction	2	2
Loss of Vision	2	2
Hyperresponsive to stimuli	2	2
Corneal Clouding/Hazing	2	6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	3
Erythema	1	1
Viral Infection	1	1
Reaction to Medicinal Component of Device	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Keratitis	1	1
Bone Fracture(s)	1	1
Fungal Infection	1	1
Fluid Discharge	1	1
Emotional Changes	1	1
Anaphylactic Shock	1	1
Drug Resistant Bacterial Infection	1	1
Halo	1	1
Ulcer	1	1
Muscle Weakness/Atrophy	1	1
Headache	1	1
Corneal Infiltrates	1	1
Excessive Tear Production	1	1
Distress	1	1