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	0

MDR Year	MDR Reports	MDR Events
2019	683	696
2020	912	919
2021	1205	1205
2022	1265	1265
2023	1048	1048
2024	254	254

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3294	3294
Scratched Material	349	349
Appropriate Term/Code Not Available	309	309
Break	224	244
Device Dislodged or Dislocated	166	166
Defective Device	160	160
Patient-Device Incompatibility	143	143
Crack	122	122
Malposition of Device	82	82
Material Opacification	80	80
Device Contamination with Chemical or Other Material	71	71
Therapeutic or Diagnostic Output Failure	50	50
Material Split, Cut or Torn	44	44
Mechanical Problem	35	35
Defective Component	30	30
Unexpected Therapeutic Results	26	26
Failure to Advance	26	26
Unintended Movement	25	25
Insufficient Information	21	21
Failure to Eject	20	20
Contamination /Decontamination Problem	19	19
Device Difficult to Setup or Prepare	19	19
Mechanical Jam	17	17
Positioning Problem	16	16
Device Damaged by Another Device	16	16
Material Deformation	12	12
Power Problem	12	12
Contamination	11	11
Material Discolored	11	11
Material Fragmentation	10	10
Application Program Problem: Power Calculation Error	10	10
Device Markings/Labelling Problem	10	10
Unstable	10	10
Inaccurate Delivery	10	10
Improper or Incorrect Procedure or Method	9	9
Failure to Unfold or Unwrap	9	9
Difficult to Fold, Unfold or Collapse	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
Ejection Problem	8	8
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Structural Problem	6	6
Difficult to Advance	6	6
Particulates	6	6
Optical Decentration	6	6
Positioning Failure	6	6
Physical Resistance/Sticking	6	6
Activation, Positioning or Separation Problem	5	5
Material Too Rigid or Stiff	5	5
Use of Device Problem	4	4
Dent in Material	4	4
Failure to Fold	4	4
Material Twisted/Bent	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Optical Problem	3	3
Patient Device Interaction Problem	3	3
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
Device Displays Incorrect Message	3	3
Detachment of Device or Device Component	3	3
Material Rupture	3	3
Device Damaged Prior to Use	3	3
Component Missing	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Slipped	2	2
Material Integrity Problem	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
Output Problem	2	2
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
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
Compatibility Problem	1	1
Difficult to Open or Close	1	1
Deformation Due to Compressive Stress	1	1
Stretched	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Blurred Vision	1628	1628
Visual Disturbances	1473	1473
Visual Impairment	1277	1277
Halo	1065	1065
No Clinical Signs, Symptoms or Conditions	509	509
No Code Available	438	438
Insufficient Information	433	433
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	345	345
No Known Impact Or Consequence To Patient	176	176
Dry Eye(s)	125	125
Discomfort	108	108
Failure of Implant	85	85
Headache	77	77
Inflammation	76	76
Eye Injury	69	69
Eye Pain	67	67
No Consequences Or Impact To Patient	61	81
Corneal Edema	58	58
Vitreous Floaters	57	57
Capsular Bag Tear	53	53
Flashers	50	50
Pain	50	50
Therapeutic Effects, Unexpected	46	46
Intraocular Pressure Increased	31	31
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	15	15
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
Zonular Dehiscence	8	8
Fibrosis	8	8
No Information	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
Foreign Body In Patient	7	7
Anxiety	7	7
Excessive Tear Production	7	7
Irritability	7	7
Patient Problem/Medical Problem	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	5	5
Scar Tissue	5	5
Keratitis	5	5
Vitreous Loss	5	5
Corneal Abrasion	5	5
Vitreous Detachment	5	5
Complaint, Ill-Defined	5	5
Injury	4	4
Depression	4	4
Prolapse	4	4
Decreased Sensitivity	4	4
Increased Sensitivity	4	4
Capsular Contracture	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
Clouding, Central Corneal	3	3
Distress	2	2
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