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
Nonstandard Device	28	32
Adverse Event Without Identified Device or Use Problem	23	23
Use of Device Problem	15	15
Patient Device Interaction Problem	11	11
Microbial Contamination of Device	8	8
Contamination of Device Ingredient or Reagent	6	6
Patient-Device Incompatibility	4	4
Product Quality Problem	3	3
Improper or Incorrect Procedure or Method	3	4
Material Opacification	2	2
Contamination	2	2
Contamination /Decontamination Problem	2	2
Output Problem	1	1
Insufficient Information	1	1
Defective Device	1	1
Obstruction of Flow	1	1
Problem with Sterilization	1	1
Delivered as Unsterile Product	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Appears to Trigger Rejection	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Eye Infections	40	44
Red Eye(s)	28	28
Eye Pain	22	22
Corneal Ulcer	16	16
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
Corneal Abrasion	4	4
Corneal Edema	4	4
Dry Eye(s)	4	8
Itching Sensation	4	4
Burning Sensation	4	4
Unspecified Infection	3	3
Swelling/ Edema	3	3
Eye Injury	3	4
Eye Burn	3	3
Increased Sensitivity	2	2
Loss of Vision	2	2
Skin Inflammation/ Irritation	2	3
Hypersensitivity/Allergic reaction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	3
Corneal Clouding/Hazing	2	6
Erythema	1	1
Viral Infection	1	1
Irritation	1	1
Insufficient Information	1	1
Reaction to Medicinal Component of Device	1	1
Keratitis	1	1
Muscle Weakness	1	1
Fluid Discharge	1	1
Bone Fracture(s)	1	1
Anaphylactic Shock	1	1
Fungal Infection	1	1
Emotional Changes	1	1
Ulcer	1	1
Drug Resistant Bacterial Infection	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Halo	1	1
Corneal Infiltrates	1	1
Excessive Tear Production	1	1
Distress	1	1