TPLC - Total Product Life Cycle

• Device: lens, intraocular, toric optics
• Regulation Description: Intraocular lens.
• Product Code: MJP
• Regulation Number: 886.3600
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
1	0	0	0	0	0

MDR Year	MDR Reports	MDR Events
2020	211	211
2021	285	288
2022	513	513
2023	748	748
2024	1101	1156
2025	201	222

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1167	1186
Scratched Material	333	335
Break	329	341
Defective Device	170	170
Device Dislodged or Dislocated	154	154
Crack	129	129
Unstable	110	110
Malposition of Device	94	94
Material Split, Cut or Torn	74	75
Failure to Eject	61	61
Appropriate Term/Code Not Available	56	56
Material Fragmentation	52	52
Device Contamination with Chemical or Other Material	47	47
Mechanical Jam	46	47
Device Difficult to Setup or Prepare	42	42
Failure to Advance	39	40
Material Discolored	38	38
Material Opacification	36	36
Device Damaged by Another Device	32	32
Defective Component	32	32
Ejection Problem	29	29
Contamination	28	29
Inaccurate Delivery	24	24
Mechanical Problem	22	22
Unintended Movement	21	21
Material Twisted/Bent	20	20
Insufficient Information	17	17
Difficult to Fold, Unfold or Collapse	17	17
Failure to Unfold or Unwrap	16	16
Operating System Becomes Nonfunctional	15	15
Material Deformation	14	14
Application Program Problem: Power Calculation Error	12	12
Physical Resistance/Sticking	12	12
Optical Decentration	10	10
Unintended Ejection	10	10
Use of Device Problem	10	10
Failure to Fold	9	9
Difficult to Insert	9	9
Device Markings/Labelling Problem	9	9
Delivered as Unsterile Product	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Device Contaminated During Manufacture or Shipping	8	8
Failure to Deliver	8	8
Product Quality Problem	8	8
Failure to Align	8	8
Application Program Problem: Dose Calculation Error	8	8
Positioning Problem	7	7
Patient-Device Incompatibility	7	7
Therapeutic or Diagnostic Output Failure	6	6
Contamination /Decontamination Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	838	865
Blurred Vision	706	711
Visual Impairment	629	633
Insufficient Information	619	619
Visual Disturbances	346	348
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	176	178
Halo	127	127
Capsular Bag Tear	75	75
Corneal Edema	57	57
Eye Injury	57	58
No Known Impact Or Consequence To Patient	55	55
No Code Available	38	38
Eye Pain	38	38
Inflammation	36	36
Dry Eye(s)	34	35
Vitreous Floaters	30	30
Discomfort	29	29
Headache	25	25
Intraocular Pressure Increased	24	24
Endophthalmitis	19	19
Macular Edema	14	14
Red Eye(s)	14	14
Zonular Dehiscence	13	13
Toxic Anterior Segment Syndrome (TASS)	12	12
No Consequences Or Impact To Patient	12	15
Uveitis	10	10
Loss of Vision	10	10
Flashers	10	10
Vitreous Loss	9	9
Excessive Tear Production	9	9
Failure of Implant	9	9
Dizziness	9	9
Fibrosis	8	8
Foreign Body Sensation in Eye	7	7
Swelling/ Edema	7	8
Therapeutic Effects, Unexpected	7	7
Unspecified Eye / Vision Problem	7	7
Retinal Detachment	6	6
Conjunctivitis	6	6
Hypopyon	6	6
Nausea	5	5
Corneal Clouding/Hazing	5	5
Itching Sensation	4	4
Adhesion(s)	4	4
No Information	4	4
Pain	4	4
Hyperemia	4	4
Eye Infections	4	4
Vitreous Detachment	4	4
Vitrectomy	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Bausch & Lomb Surgical, Inc.	II	Dec-02-2020
2	Johnson & Johnson Surgical Vision Inc	II	Oct-04-2021
3	Johnson & Johnson Surgical Vision Inc	II	Mar-03-2021
4	Johnson & Johnson Surgical Vision, Inc.	II	Jan-16-2024