TPLC - Total Product Life Cycle

• Device: intraocular lens
• Regulation Description: Intraocular lens.
• Product Code: HQL
• Regulation Number: 886.3600
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
53	34	29	35	42	13

MDR Year	MDR Reports	MDR Events
2021	2925	3097
2022	3290	3306
2023	3906	3958
2024	3197	4164
2025	3981	5388
2026	1371	1720

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4041	4972
Adverse Event Without Identified Device or Use Problem	3120	3446
Scratched Material	1967	2089
Material Split, Cut or Torn	1408	1415
Crack	1041	1108
Device Difficult to Setup or Prepare	812	824
Defective Device	747	747
Failure to Advance	684	685
Failure to Eject	662	662
Material Twisted/Bent	620	620
Material Fragmentation	566	598
Device Damaged by Another Device	492	492
Use of Device Problem	480	484
Failure to Deliver	474	474
Inaccurate Delivery	454	454
Device Dislodged or Dislocated	413	419
Contamination	410	443
Material Opacification	388	401
Ejection Problem	379	410
Appropriate Term/Code Not Available	310	315
Mechanical Jam	305	324
Difficult to Fold, Unfold or Collapse	285	315
Failure to Unfold or Unwrap	284	284
Off-Label Use	261	261
Failure to Fold	248	252
Device Contamination with Chemical or Other Material	218	218
Insufficient Information	197	197
Defective Component	192	193
Material Deformation	186	186
Physical Resistance/Sticking	179	196
Product Quality Problem	152	157
Material Discolored	132	132
Mechanical Problem	132	134
Material Integrity Problem	124	124
Difficult to Advance	95	95
Unintended Ejection	91	91
Delivered as Unsterile Product	87	88
Operating System Becomes Nonfunctional	83	84
Device Contaminated During Manufacture or Shipping	82	82
Malposition of Device	79	79
Difficult to Insert	77	79
Manufacturing, Packaging or Shipping Problem	74	76
Sharp Edges	74	74
Optical Problem	63	63
Particulates	61	61
Contamination /Decontamination Problem	51	51
Device Appears to Trigger Rejection	49	49
Failure to Prime	46	46
Material Too Rigid or Stiff	46	47
Unstable	44	44

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9113	10946
Insufficient Information	4445	4467
Visual Impairment	1550	1570
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	992	1086
Blurred Vision	988	1016
Visual Disturbances	899	941
Capsular Bag Tear	762	781
Failure of Implant	632	638
Eye Injury	482	502
Halo	260	265
Inflammation	246	248
Corneal Edema	243	246
Endophthalmitis	180	187
Toxic Anterior Segment Syndrome (TASS)	178	183
Eye Pain	153	154
Intraocular Pressure Increased	127	175
Discomfort	91	95
Flashers	82	86
Uveitis	81	131
Zonular Dehiscence	72	72
Dry Eye(s)	67	70
Hypopyon	56	56
Vitreous Floaters	56	57
Macular Edema	54	104
Unspecified Eye / Vision Problem	48	52
Red Eye(s)	47	47
Retinal Detachment	46	95
Fibrosis	43	45
Headache	41	44
Vitreous Loss	39	39
Hyphema	36	37
No Consequences Or Impact To Patient	35	189
Iritis	34	34
Glaucoma	33	33
Swelling/ Edema	28	28
Eye Infections	28	33
Foreign Body Sensation in Eye	26	27
Vitreous Hemorrhage	23	23
Keratitis	22	22
Prolapse	18	18
Loss of Vision	18	18
Hyperemia	17	17
No Code Available	17	17
Corneal Clouding/Hazing	17	17
Hemorrhage/Bleeding	16	16
Foreign Body In Patient	16	16
Capsular Contracture	16	16
Conjunctivitis	15	15
Dizziness	15	15
Corneal Decompensation	15	15

Recalls
Manufacturer		Recall Class	Date Posted
1	AMO Puerto Rico Manufacturing, Inc.	II	Mar-24-2026
2	Alcon Laboratories Ireland, Ltd	II	Jun-17-2022
3	Bausch & Lomb Surgical, Inc.	III	Aug-26-2025
4	Bausch & Lomb Surgical, Inc.	I	May-02-2025
5	Johnson & Johnson Surgical Vision, Inc.	II	Aug-03-2023
6	Rayner Intraocular Lenses Ltd	II	Jul-06-2022