TPLC - Total Product Life Cycle

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Device	device, irrigation, ocular surgery
Regulation Description	Ocular surgery irrigation device.
Product Code	KYG
Regulation Number	886.4360
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	43	43
Suction Failure	32	32
Adverse Event Without Identified Device or Use Problem	29	29
Sharp Edges	27	27
Material Twisted/Bent	26	26
Complete Blockage	20	20
Obstruction of Flow	11	11
Component Missing	6	14
Decrease in Suction	6	6
Misassembled	6	14
Delivered as Unsterile Product	6	14
Detachment of Device or Device Component	5	5
Suction Problem	4	4
Defective Component	3	3
Material Fragmentation	3	3
Fitting Problem	2	2
Insufficient Information	2	2
Particulates	2	2
Intermittent Infusion	2	2
Material Protrusion/Extrusion	2	2
Appropriate Term/Code Not Available	2	2
Connection Problem	2	2
Loose or Intermittent Connection	2	2
Dull, Blunt	2	2
Pressure Problem	1	1
Material Split, Cut or Torn	1	1
Crack	1	1
Device Damaged Prior to Use	1	1
Inability to Irrigate	1	1
Material Puncture/Hole	1	1
Defective Device	1	1
Structural Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	105	113
Insufficient Information	50	50
Capsular Bag Tear	41	41
Toxic Anterior Segment Syndrome (TASS)	17	17
Uveitis	10	10
Corneal Edema	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Rupture	7	7
Inflammation	5	5
Conjunctivitis	4	4
Vitritis	4	4
Intraocular Pressure Increased	3	3
Hypopyon	3	3
Endophthalmitis	3	3
Red Eye(s)	2	2
Eye Burn	2	2
Unspecified Eye / Vision Problem	2	2
Blurred Vision	2	2
Eye Pain	2	2
Fibrosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B. Braun Medical, Inc.	II	Nov-03-2023