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
Dull, Blunt	119	119
Adverse Event Without Identified Device or Use Problem	53	53
Device Contamination with Chemical or Other Material	38	38
Break	32	32
Failure to Cut	26	26
Fluid/Blood Leak	22	22
Device Operates Differently Than Expected	21	21
Fitting Problem	17	17
Material Twisted/Bent	16	16
Leak/Splash	14	14
Sharp Edges	10	10
Component Missing	10	18
Complete Blockage	9	9
Suction Failure	9	9
Detachment Of Device Component	8	8
Particulates	8	8
Scratched Material	8	8
Appropriate Term/Code Not Available	6	6
Delivered as Unsterile Product	6	14
Material Deformation	6	6
Misassembled	6	14
Bent	6	6
Detachment of Device or Device Component	6	6
Insufficient Information	6	6
Device Dislodged or Dislocated	5	5
Device Operational Issue	5	5
Material Integrity Problem	4	4
Defective Device	4	4
Defective Component	4	4
Material Fragmentation	4	4
Device Issue	4	4
Torn Material	4	4
Obstruction of Flow	3	3
Use of Device Problem	3	3
Occlusion Within Device	3	3
Loose or Intermittent Connection	3	3
Inability to Irrigate	3	3
Connection Problem	3	3
Suction Problem	3	3
Structural Problem	3	3
Crack	2	2
Kinked	2	2
Migration or Expulsion of Device	2	2
Collapse	2	2
Product Quality Problem	2	2
Material Separation	2	2
Material Too Rigid or Stiff	2	2
Infusion or Flow Problem	2	2
Aspiration Issue	2	2
Material Distortion	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	184	184
No Known Impact Or Consequence To Patient	67	67
No Clinical Signs, Symptoms or Conditions	58	66
Capsular Bag Tear	46	46
No Patient Involvement	38	38
Foreign Body In Patient	33	33
Insufficient Information	19	19
No Code Available	16	16
Uveitis	12	12
No Information	12	12
Toxic Anterior Segment Syndrome (TASS)	12	12
Rupture	11	11
Endophthalmitis	10	10
Inflammation	10	10
Corneal Edema	9	9
Vitritis	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Eye Injury	6	6
Vitrectomy	5	5
Intraocular Pressure, Delayed, Uncontrolled	4	4
Blurred Vision	2	2
Visual Impairment	2	2
Conjunctivitis	2	2
Eye Burn	2	2
Hypopyon	2	2
Unspecified Infection	2	2
Rash	1	1
Exposure to Body Fluids	1	1
Retinal Detachment	1	1
Erythema	1	1
Swelling	1	1
Needle Stick/Puncture	1	1
Cataract, Induced	1	1
Corneal Decompensation	1	1
Corneal Abrasion	1	1
Collapse	1	1
Intraocular Infection	1	1
Macular Edema	1	1
Hyphema	1	1
Intraocular Pressure Increased	1	1
Reinfusion	1	1
Hemorrhage/Bleeding	1	1
Thromboembolism	1	1
Fibrosis	1	1
Corneal Scar	1	1
Foreign Body Sensation in Eye	1	1
Retinal Tear	1	1
Excessive Tear Production	1	1

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