TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
0	1	0	0	0	0

MDR Year	MDR Reports	MDR Events
2019	382	382
2020	211	211
2021	285	288
2022	511	511
2023	748	748
2024	234	234

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	815	815
Scratched Material	268	268
Break	262	265
Defective Device	125	125
Crack	114	114
Device Dislodged or Dislocated	111	111
Appropriate Term/Code Not Available	96	96
Unstable	94	94
Malposition of Device	71	71
Device Contamination with Chemical or Other Material	51	51
Material Split, Cut or Torn	39	39
Mechanical Jam	35	35
Material Fragmentation	35	35
Defective Component	28	28
Failure to Advance	26	26
Failure to Eject	23	23
Patient-Device Incompatibility	22	22
Inaccurate Delivery	21	21
Unintended Movement	21	21
Ejection Problem	20	20
Device Damaged by Another Device	20	20
Contamination	20	20
Material Opacification	20	20
Mechanical Problem	19	19
Device Difficult to Setup or Prepare	14	14
Insufficient Information	14	14
Positioning Problem	14	14
Contamination /Decontamination Problem	13	13
Failure to Unfold or Unwrap	12	12
Unexpected Therapeutic Results	11	11
Operating System Becomes Nonfunctional	11	11
Therapeutic or Diagnostic Output Failure	10	10
Application Program Problem: Power Calculation Error	10	10
Difficult to Fold, Unfold or Collapse	9	9
Failure to Align	9	9
Physical Resistance/Sticking	9	9
Device Markings/Labelling Problem	8	8
Device Contaminated During Manufacture or Shipping	8	8
Material Deformation	8	8
Material Twisted/Bent	7	7
Unintended Ejection	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Migration	7	7
Delivered as Unsterile Product	6	6
Material Discolored	6	6
Application Program Problem: Dose Calculation Error	6	6
Device Damaged Prior to Use	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Migration or Expulsion of Device	5	5
Difficult to Insert	5	5
Use of Device Problem	5	5
Material Too Rigid or Stiff	4	4
Optical Decentration	4	4
Difficult to Advance	4	4
Component Missing	4	4
Overcorrection	4	4
Power Problem	3	3
Output Problem	3	3
Patient Device Interaction Problem	3	3
Structural Problem	3	3
Activation, Positioning or Separation Problem	3	3
Device Slipped	3	3
Failure to Fold	2	2
Particulates	2	2
Positioning Failure	2	2
Detachment of Device or Device Component	2	2
Material Integrity Problem	2	2
Device Displays Incorrect Message	2	2
Optical Distortion	2	2
Optical Problem	1	1
Optical Discoloration	1	1
Packaging Problem	1	1
Blocked Connection	1	1
Dent in Material	1	1
Failure to Deliver	1	1
Microbial Contamination of Device	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Gas/Air Leak	1	1
Compatibility Problem	1	1
Entrapment of Device	1	1
Device Alarm System	1	1
Calcified	1	1
Complete Blockage	1	1
Incorrect Measurement	1	1
Misassembled	1	1
Poor Quality Image	1	1
Unintended Collision	1	1
Fracture	1	1
Problem with Sterilization	1	1
Vibration	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	574	574
Blurred Vision	463	463
Visual Impairment	443	443
Insufficient Information	335	335
Visual Disturbances	226	226
No Known Impact Or Consequence To Patient	181	181
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	149	149
Halo	87	87
No Code Available	73	73
Capsular Bag Tear	64	64
Inflammation	49	49
Corneal Edema	46	47
Eye Injury	43	43
Endophthalmitis	33	33
Dry Eye(s)	28	28
Failure of Implant	28	28
Discomfort	28	28
No Consequences Or Impact To Patient	26	29
Eye Pain	24	24
Intraocular Pressure Increased	17	17
Vitreous Floaters	17	17
Headache	16	16
Pain	16	17
Red Eye(s)	15	15
Loss of Vision	13	13
Zonular Dehiscence	13	13
Therapeutic Effects, Unexpected	12	12
Macular Edema	11	11
Toxic Anterior Segment Syndrome (TASS)	11	11
Vitrectomy	10	10
Vitreous Loss	9	9
Uveitis	8	8
No Patient Involvement	8	8
Flashers	8	8
Foreign Body Sensation in Eye	8	8
Hypopyon	8	8
Conjunctivitis	7	7
Excessive Tear Production	7	7
No Information	7	7
Dizziness	7	7
Therapeutic Response, Decreased	6	6
Vitreous Detachment	6	6
Itching Sensation	6	6
Corneal Clouding/Hazing	5	5
Hyperemia	5	5
Adhesion(s)	5	5
Hemorrhage/Bleeding	4	4
Patient Problem/Medical Problem	4	4
Fibrosis	4	4
Unspecified Eye / Vision Problem	4	4
Eye Infections	4	4
Swelling/ Edema	3	3
Glaucoma	3	3
Keratitis	3	3
Nausea	3	3
Corneal Decompensation	3	3
Retinal Detachment	3	3
Burning Sensation	3	3
Retinal Tear	2	2
Scarring	2	2
Increased Sensitivity	2	2
Swelling	2	2
Prolapse	2	2
Decreased Sensitivity	2	2
Foreign Body In Patient	2	2
Anxiety	2	2
Complaint, Ill-Defined	2	2
Impaired Healing	2	2
Inadequate Pain Relief	2	2
Erythema	2	2
Capsular Contracture	2	2
Ecchymosis	2	2
Iritis	2	2
Hypersensitivity/Allergic reaction	2	2
Corneal Epithelial Microcysts	2	2
Irritability	2	2
Device Embedded In Tissue or Plaque	1	1
Unspecified Nervous System Problem	1	1
Intraocular Pressure Decreased	1	1
UGH (Uveitis Glaucoma Hyphema) Syndrome	1	1
Hyphema	1	1
Unspecified Infection	1	1
Optical Nerve Damage	1	1
Edema	1	1
Corneal Scar	1	1
Deposits	1	1
Autoimmune Reaction	1	1
Bacterial Infection	1	1
Bruise/Contusion	1	1
Calcium Deposits/Calcification	1	1
Reaction	1	1
Joint Dislocation	1	1
Shaking/Tremors	1	1
Blood Loss	1	1
Staphylococcus Aureus	1	1
Scar Tissue	1	1
Vitritis	1	1
Rupture	1	1

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