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	32	32
Break	28	28
Material Twisted/Bent	16	16
Sharp Edges	10	10
Suction Failure	9	9
Complete Blockage	9	9
Component Missing	6	14
Misassembled	6	14
Delivered as Unsterile Product	6	14
Scratched Material	5	5
Defective Device	4	4
Suction Problem	3	3
Structural Problem	3	3
Material Fragmentation	3	3
Loose or Intermittent Connection	3	3
Obstruction of Flow	2	2
Connection Problem	2	2
Disconnection	2	2
Decrease in Suction	2	2
Particulates	2	2
Device Operates Differently Than Expected	2	2
Appropriate Term/Code Not Available	2	2
Inability to Irrigate	2	2
Defective Component	2	2
Material Integrity Problem	2	2
Malposition of Device	1	1
Aspiration Issue	1	1
Material Too Rigid or Stiff	1	1
Material Deformation	1	1
Pressure Problem	1	1
Material Split, Cut or Torn	1	1
Crack	1	1
Infusion or Flow Problem	1	1
Material Puncture/Hole	1	1
Insufficient Information	1	1
Device Contamination with Chemical or Other Material	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Noise, Audible	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	58	66
Capsular Bag Tear	35	35
Insufficient Information	19	19
Toxic Anterior Segment Syndrome (TASS)	12	12
No Known Impact Or Consequence To Patient	12	12
Uveitis	10	10
Rupture	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Vitritis	4	4
Corneal Edema	4	4
No Consequences Or Impact To Patient	4	4
Inflammation	3	3
Eye Burn	2	2
Conjunctivitis	2	2
Unspecified Infection	1	1
Hypopyon	1	1
No Code Available	1	1
No Information	1	1
Blurred Vision	1	1
Fibrosis	1	1
Excessive Tear Production	1	1

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