TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	30	30
Break	18	18
Material Twisted/Bent	11	11
Suction Failure	7	7
Sharp Edges	5	5
Misassembled	4	4
Delivered as Unsterile Product	4	4
Component Missing	4	4
Material Fragmentation	3	3
Suction Problem	3	3
Complete Blockage	3	3
Scratched Material	3	3
Structural Problem	3	3
Connection Problem	2	2
Particulates	2	2
Defective Component	2	2
Disconnection	2	2
Obstruction of Flow	2	2
Dull, Blunt	1	1
Inability to Irrigate	1	1
Loose or Intermittent Connection	1	1
Material Puncture/Hole	1	1
Crack	1	1
Decrease in Suction	1	1
Detachment of Device or Device Component	1	1
Material Deformation	1	1
Defective Device	1	1
Malposition of Device	1	1
Appropriate Term/Code Not Available	1	1
Material Split, Cut or Torn	1	1
Pressure Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
Capsular Bag Tear	24	24
Toxic Anterior Segment Syndrome (TASS)	12	12
Uveitis	10	10
Insufficient Information	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Rupture	6	6
No Known Impact Or Consequence To Patient	5	5
Vitritis	4	4
Corneal Edema	4	4
Inflammation	3	3
Conjunctivitis	2	2
No Consequences Or Impact To Patient	2	2
Eye Burn	2	2
Fibrosis	1	1
No Code Available	1	1
Blurred Vision	1	1
Hypopyon	1	1
Unspecified Infection	1	1

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