TPLC - Total Product Life Cycle

• Device: lens, multifocal intraocular
• Product Code: MFK
• Regulation Number: 886.3600
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
8	4	8	8	6	5

MDR Year	MDR Reports	MDR Events
2019	683	696
2020	912	919
2021	1205	1205
2022	1265	1265
2023	1048	1048
2024	472	494

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3433	3446
Scratched Material	368	368
Appropriate Term/Code Not Available	313	313
Break	237	257
Device Dislodged or Dislocated	175	175
Defective Device	168	168
Patient-Device Incompatibility	143	143
Crack	127	127
Material Opacification	86	86
Malposition of Device	84	84
Device Contamination with Chemical or Other Material	71	71
Therapeutic or Diagnostic Output Failure	50	50
Material Split, Cut or Torn	45	45
Mechanical Problem	35	35
Defective Component	31	31
Unexpected Therapeutic Results	26	26
Failure to Advance	26	26
Unintended Movement	25	25
Failure to Eject	22	22
Insufficient Information	21	21
Device Difficult to Setup or Prepare	21	21
Contamination /Decontamination Problem	19	19
Material Deformation	18	18
Mechanical Jam	18	18
Device Damaged by Another Device	17	17
Positioning Problem	16	16
Material Discolored	14	14
Contamination	13	13
Material Fragmentation	12	12
Power Problem	12	12
Ejection Problem	11	11
Difficult to Fold, Unfold or Collapse	11	11
Application Program Problem: Power Calculation Error	11	11
Unstable	11	11
Inaccurate Delivery	10	10
Device Markings/Labelling Problem	10	10
Improper or Incorrect Procedure or Method	9	9
Failure to Unfold or Unwrap	9	9
Optical Decentration	9	9
Application Program Problem: Dose Calculation Error	9	9
Product Quality Problem	8	8
Failure to Align	8	8
Operating System Becomes Nonfunctional	8	8
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Material Too Rigid or Stiff	6	6
Structural Problem	6	6
Difficult to Advance	6	6
Particulates	6	6
Positioning Failure	6	6
Material Twisted/Bent	6	6
Physical Resistance/Sticking	6	6
Activation, Positioning or Separation Problem	5	5
Dent in Material	5	5
Device Damaged Prior to Use	4	4
Use of Device Problem	4	4
Failure to Fold	4	4
Fracture	3	3
Material Frayed	3	3
Difficult to Insert	3	3
Labelling, Instructions for Use or Training Problem	3	3
Entrapment of Device	3	3
Incorrect Measurement	3	3
Delivered as Unsterile Product	3	3
Material Rupture	3	3
Device Displays Incorrect Message	3	3
Detachment of Device or Device Component	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Optical Problem	3	3
Patient Device Interaction Problem	3	3
Output Problem	2	2
Material Integrity Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Slipped	2	2
Component Missing	2	2
Loose or Intermittent Connection	2	2
Migration or Expulsion of Device	2	2
Unintended Ejection	2	2
Fogging	2	2
Calcified	2	2
Biofilm coating in Device	1	1
Leak/Splash	1	1
Image Orientation Incorrect	1	1
Degraded	1	1
Misassembled	1	1
Misfocusing	1	1
Unable to Obtain Readings	1	1
Difficult to Remove	1	1
Material Puncture/Hole	1	1
Fitting Problem	1	1
Stretched	1	1
Compatibility Problem	1	1
Difficult to Open or Close	1	1
Deformation Due to Compressive Stress	1	1
Optical Distortion	1	1
Mechanics Altered	1	1
Material Too Soft/Flexible	1	1
Sharp Edges	1	1
Activation Problem	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Blurred Vision	1714	1718
Visual Disturbances	1532	1536
Visual Impairment	1323	1325
Halo	1101	1104
No Clinical Signs, Symptoms or Conditions	545	546
Insufficient Information	462	462
No Code Available	438	438
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	351	351
No Known Impact Or Consequence To Patient	176	176
Dry Eye(s)	128	128
Discomfort	115	115
Failure of Implant	87	87
Headache	79	79
Eye Injury	78	78
Inflammation	77	77
Eye Pain	74	75
Corneal Edema	62	62
No Consequences Or Impact To Patient	61	81
Vitreous Floaters	60	60
Capsular Bag Tear	57	57
Flashers	50	50
Pain	50	50
Therapeutic Effects, Unexpected	46	46
Intraocular Pressure Increased	33	33
Loss of Vision	30	30
Endophthalmitis	30	30
Foreign Body Sensation in Eye	29	29
Red Eye(s)	26	26
Vitrectomy	25	25
Unspecified Eye / Vision Problem	23	23
Macular Edema	21	21
Uveitis	18	18
Dizziness	16	16
Swelling	14	14
Unspecified Infection	14	14
No Patient Involvement	11	11
Inadequate Pain Relief	10	10
Swelling/ Edema	10	10
Toxic Anterior Segment Syndrome (TASS)	9	9
Therapeutic Response, Decreased	9	9
Fibrosis	9	9
No Information	8	8
Zonular Dehiscence	8	8
Excessive Tear Production	8	8
Corneal Clouding/Hazing	8	8
Conjunctivitis	8	8
Iritis	8	8
Nausea	8	8
Increased Sensitivity	7	7
Burning Sensation	7	7
Corneal Scar	7	7
Hypopyon	7	7
Anxiety	7	7
Irritability	7	7
Foreign Body In Patient	7	7
Patient Problem/Medical Problem	6	6
Vitreous Detachment	6	6
Hemorrhage/Bleeding	6	6
Fatigue	6	6
Emotional Changes	6	6
Vertigo	6	6
Itching Sensation	6	6
Retinal Detachment	6	6
Retinal Tear	6	6
Scar Tissue	5	5
Keratitis	5	5
Vitreous Loss	5	5
Corneal Abrasion	5	5
Capsular Contracture	5	5
Prolapse	5	5
Complaint, Ill-Defined	5	5
Injury	4	4
Depression	4	4
Decreased Sensitivity	4	4
Increased Sensitivity	4	4
Cataract	4	4
Hypersensitivity/Allergic reaction	4	4
Hyphema	4	4
Hyperemia	3	3
Cataract, Induced	3	3
Fall	3	3
Scarring	3	3
Distress	3	3
Clouding, Central Corneal	3	3
Impaired Healing	2	2
Confusion/ Disorientation	2	2
Unspecified Tissue Injury	2	2
UGH (Uveitis Glaucoma Hyphema) Syndrome	2	2
Corneal Epithelial Microcysts	2	2
Staphylococcus Aureus	2	2
Nerve Damage	2	2
Vitreous Hemorrhage	2	2
Twitching	2	2
Vitritis	2	2
Retinal Degeneration	2	2
Tissue Damage	2	2
Edema	2	2
Purulent Discharge	2	2
Chemosis	1	1
Erythema	1	1