TPLC - Total Product Life Cycle

show TPLC since

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	52	52
Suction Failure	51	51
Material Twisted/Bent	34	34
Adverse Event Without Identified Device or Use Problem	30	30
Sharp Edges	30	30
Complete Blockage	20	20
Obstruction of Flow	20	20
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 Device Problem Term/Code Not Available	3	3
Insufficient Device Problem Information	2	2
Particulates	2	2
Device Contamination with Chemical or Other Material	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
Defective Device	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	131	139
Insufficient Information	64	64
Capsular Bag Tear	45	45
Toxic Anterior Segment Syndrome (TASS)	17	17
Uveitis	10	10
Corneal Edema	8	8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	7	7
Endophthalmitis	5	5
Inflammation	5	5
Rupture	5	5
Conjunctivitis	4	4
Vitritis	4	4
Intraocular Pressure Increased	3	3
Hypopyon	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