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	3

MDR Year	MDR Reports	MDR Events
2021	2925	3097
2022	3290	3306
2023	3906	3958
2024	3197	4164
2025	3980	5387
2026	303	370

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3847	4700
Adverse Event Without Identified Device or Use Problem	2943	3244
Scratched Material	1866	1980
Material Split, Cut or Torn	1321	1328
Crack	1006	1067
Defective Device	740	740
Device Difficult to Setup or Prepare	659	671
Failure to Eject	654	654
Failure to Advance	618	619
Material Fragmentation	548	574
Material Twisted/Bent	529	529
Use of Device Problem	464	468
Device Damaged by Another Device	439	439
Inaccurate Delivery	437	437
Device Dislodged or Dislocated	394	400
Contamination	390	417
Failure to Deliver	376	376
Material Opacification	376	388
Ejection Problem	359	387
Appropriate Term/Code Not Available	305	309
Mechanical Jam	293	307
Difficult to Fold, Unfold or Collapse	280	309
Failure to Unfold or Unwrap	257	257
Off-Label Use	255	255
Failure to Fold	231	235
Device Contamination with Chemical or Other Material	218	218
Defective Component	191	192
Insufficient Information	184	184
Physical Resistance/Sticking	178	195
Material Deformation	147	147
Mechanical Problem	130	132
Material Discolored	127	127
Material Integrity Problem	116	116
Product Quality Problem	116	121
Difficult to Advance	95	95
Unintended Ejection	91	91
Device Contaminated During Manufacture or Shipping	82	82
Delivered as Unsterile Product	81	82
Operating System Becomes Nonfunctional	80	81
Malposition of Device	77	77
Difficult to Insert	73	75
Sharp Edges	71	71
Manufacturing, Packaging or Shipping Problem	69	71
Particulates	57	57
Optical Problem	55	55
Contamination /Decontamination Problem	51	51
Device Appears to Trigger Rejection	49	49
Material Too Rigid or Stiff	46	47
Unstable	44	44
No Apparent Adverse Event	38	38

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8655	10303
Insufficient Information	3985	4007
Visual Impairment	1476	1494
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	974	1067
Blurred Vision	917	944
Visual Disturbances	863	901
Capsular Bag Tear	739	757
Failure of Implant	615	621
Eye Injury	460	478
Halo	253	257
Corneal Edema	231	234
Inflammation	210	211
Endophthalmitis	170	177
Toxic Anterior Segment Syndrome (TASS)	170	175
Eye Pain	148	149
Intraocular Pressure Increased	118	166
Discomfort	90	94
Uveitis	80	130
Flashers	79	83
Zonular Dehiscence	70	70
Dry Eye(s)	65	68
Vitreous Floaters	55	56
Macular Edema	53	101
Hypopyon	50	50
Red Eye(s)	47	47
Unspecified Eye / Vision Problem	46	50
Retinal Detachment	46	95
Vitreous Loss	38	38
Headache	38	41
No Consequences Or Impact To Patient	35	189
Hyphema	34	35
Glaucoma	33	33
Iritis	33	33
Fibrosis	32	34
Swelling/ Edema	28	28
Foreign Body Sensation in Eye	26	27
Eye Infections	26	31
Keratitis	22	22
Vitreous Hemorrhage	22	22
Prolapse	18	18
Loss of Vision	17	17
No Code Available	17	17
Corneal Clouding/Hazing	17	17
Hemorrhage/Bleeding	16	16
Capsular Contracture	16	16
Foreign Body In Patient	16	16
Hyperemia	15	15
Excessive Tear Production	15	15
Vitreous Detachment	15	15
Conjunctivitis	15	15

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