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	48	48
Suction Failure	46	46
Sharp Edges	30	30
Material Twisted/Bent	29	29
Adverse Event Without Identified Device or Use Problem	29	29
Complete Blockage	20	20
Obstruction of Flow	15	15
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
Intermittent Infusion	4	4
Suction Problem	4	4
Fitting Problem	3	3
Defective Component	3	3
Material Fragmentation	3	3
Appropriate Term/Code Not Available	3	3
Insufficient Information	2	2
Particulates	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
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	121	129
Insufficient Information	57	57
Capsular Bag Tear	45	45
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
Inflammation	5	5
Rupture	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
Intraocular Pressure Decreased	1	1
Fibrosis	1	1

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