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	790	826

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1287	1308
Scratched Material	381	383
Break	376	391
Material Discolored	250	250
Device Dislodged or Dislocated	178	178
Defective Device	170	170
Crack	134	134
Unstable	116	116
Malposition of Device	94	94
Material Split, Cut or Torn	90	91
Device Difficult to Setup or Prepare	66	67
Failure to Eject	61	61
Appropriate Term/Code Not Available	58	58
Material Fragmentation	55	55
Failure to Advance	48	50
Device Contamination with Chemical or Other Material	47	47
Mechanical Jam	46	47
Material Opacification	44	44
Device Damaged by Another Device	40	40
Failure to Deliver	40	40
Material Twisted/Bent	36	36
Ejection Problem	35	35
Defective Component	32	32
Contamination	30	31
Inaccurate Delivery	28	28
Mechanical Problem	26	27
Product Quality Problem	26	26
Unintended Movement	22	22
Insufficient Information	22	22
Material Deformation	20	20
Difficult to Fold, Unfold or Collapse	19	19
Failure to Unfold or Unwrap	19	19
Operating System Becomes Nonfunctional	15	15
Application Program Problem: Power Calculation Error	12	12
Failure to Fold	12	12
Physical Resistance/Sticking	12	12
Optical Decentration	11	11
Unintended Ejection	10	10
Use of Device Problem	10	10
Delivered as Unsterile Product	9	9
Difficult to Insert	9	9
Device Markings/Labelling Problem	9	9
Particulates	9	9
Device Contaminated During Manufacture or Shipping	8	8
Manufacturing, Packaging or Shipping Problem	8	8
Failure to Align	8	8
Application Program Problem: Dose Calculation Error	8	8
Patient-Device Incompatibility	7	7
Positioning Problem	7	7
Device Damaged Prior to Use	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1159	1193
Blurred Vision	769	774
Insufficient Information	740	740
Visual Impairment	703	709
Visual Disturbances	398	400
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	184	186
Halo	132	132
Capsular Bag Tear	83	84
Corneal Edema	64	64
Eye Injury	62	63
No Known Impact Or Consequence To Patient	55	55
Eye Pain	42	42
Inflammation	40	40
No Code Available	38	38
Dry Eye(s)	36	37
Discomfort	32	32
Vitreous Floaters	31	31
Headache	29	29
Intraocular Pressure Increased	27	27
Endophthalmitis	22	22
Toxic Anterior Segment Syndrome (TASS)	16	16
Macular Edema	15	15
Red Eye(s)	14	14
Zonular Dehiscence	14	14
No Consequences Or Impact To Patient	12	15
Uveitis	10	10
Loss of Vision	10	10
Dizziness	10	10
Flashers	10	10
Excessive Tear Production	9	9
Vitreous Loss	9	9
Hypopyon	9	9
Failure of Implant	9	9
Fibrosis	8	8
Therapeutic Effects, Unexpected	7	7
Swelling/ Edema	7	8
Unspecified Eye / Vision Problem	7	7
Foreign Body Sensation in Eye	7	7
Conjunctivitis	6	6
Retinal Detachment	6	6
Corneal Clouding/Hazing	5	5
Nausea	5	5
Itching Sensation	4	4
Adhesion(s)	4	4
Vitrectomy	4	4
Pain	4	4
Hyperemia	4	4
No Information	4	4
Eye Infections	4	4
Vitreous Detachment	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