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	28	28
Adverse Event Without Identified Device or Use Problem	27	27
Sharp Edges	23	23
Material Twisted/Bent	21	21
Complete Blockage	19	19
Suction Failure	17	17
Component Missing	6	14
Decrease in Suction	6	6
Misassembled	6	14
Delivered as Unsterile Product	6	14
Obstruction of Flow	5	5
Material Fragmentation	3	3
Detachment of Device or Device Component	3	3
Suction Problem	3	3
Defective Component	2	2
Particulates	2	2
Structural Problem	2	2
Connection Problem	2	2
Loose or Intermittent Connection	2	2
Pressure Problem	1	1
Material Split, Cut or Torn	1	1
Malposition of Device	1	1
Crack	1	1
Inability to Irrigate	1	1
Material Puncture/Hole	1	1
Defective Device	1	1
Scratched Material	1	1
Material Deformation	1	1
Material Separation	1	1
Appropriate Term/Code Not Available	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	87
Capsular Bag Tear	37	37
Insufficient Information	36	36
Toxic Anterior Segment Syndrome (TASS)	12	12
Uveitis	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Rupture	5	5
Vitritis	4	4
Corneal Edema	4	4
Inflammation	3	3
Eye Burn	2	2
Conjunctivitis	2	2
Unspecified Infection	1	1
Hypopyon	1	1
Unspecified Eye / Vision Problem	1	1
Blurred Vision	1	1
Fibrosis	1	1

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