TPLC - Total Product Life Cycle

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Device	gases used within eye to place pressure on detached retina
Regulation Description	Intraocular gas.
Product Code	LPO
Regulation Number	886.4270
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
1	2	0	8	6	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	144	144
Gas Output Problem	31	31
Appropriate Term/Code Not Available	19	19
Failure to Deliver	11	11
Short Fill	8	8
Gas/Air Leak	3	3
Off-Label Use	2	2
Defective Component	2	2
Restricted Flow rate	1	1
Insufficient Information	1	1
Use of Device Problem	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	74	74
No Clinical Signs, Symptoms or Conditions	52	52
Glaucoma	44	44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
Retinal Detachment	13	13
Visual Impairment	6	6
Intraocular Pressure Decreased	5	5
Cataract	4	4
Inflammation	4	4
Vitreous Floaters	4	4
Visual Disturbances	3	3
Eye Injury	3	3
Loss of Vision	3	3
Retinal Tear	3	3
Corneal Clouding/Hazing	2	2
Retinal Degeneration	2	2
Obstruction/Occlusion	2	2
Eye Burn	2	2
Retinal Injury	2	2
Fever	2	2
Flashers	2	2
Conjunctivitis	2	2
Insufficient Information	2	2
Corneal Edema	2	2
Blurred Vision	2	2
Hyperemia	2	2
Nausea	1	1
Endophthalmitis	1	1
Dry Eye(s)	1	1
Ischemia	1	1
Pain	1	1
Vitreous Hemorrhage	1	1
Hyphema	1	1
Pupillary Block	1	1
Eye Pain	1	1