TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
33	44	32	38	30	18	27	48	41	39	57	49	53	34	29	13

MDR Year	MDR Reports	MDR Events
2014	2649	2649
2015	4673	4673
2016	2214	2214
2017	2386	2386
2018	2501	2501
2019	3086	3603
2020	1981	3096
2021	2925	3096
2022	3290	3290
2023	3909	3957
2024	1513	1620

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6975	7035
Break	4521	6001
Packaging Problem	2296	2296
Leak/Splash	2245	2245
Scratched Material	1871	1941
Appropriate Term/Code Not Available	1269	1271
Crack	1192	1335
Material Split, Cut or Torn	934	934
Material Opacification	826	826
Defective Device	808	808
Device Contamination with Chemical or Other Material	806	806
Device Operates Differently Than Expected	627	627
Failure to Eject	621	621
Insufficient Information	610	610
Torn Material	574	574
Device Dislodged or Dislocated	554	554
Contamination	512	512
Unintended Movement	477	477
Use of Device Problem	447	447
Material Fragmentation	420	421
Sticking	419	419
Difficult to Fold, Unfold or Collapse	373	374
Inaccurate Delivery	372	372
Failure to Advance	371	371
Failure to Unfold or Unwrap	312	312
Mechanical Jam	290	290
Malposition of Device	289	289
Device Damaged by Another Device	255	301
Physical Resistance/Sticking	245	245
Material Twisted/Bent	239	239
Difficult or Delayed Positioning	229	229
No Apparent Adverse Event	226	226
Defective Component	222	337
Positioning Failure	221	221
Inadequacy of Device Shape and/or Size	213	213
Off-Label Use	206	206
Failure to Fold	197	197
Bent	187	187
Ejection Problem	186	186
Material Deformation	181	181
Contamination /Decontamination Problem	165	165
Material Integrity Problem	148	148
Positioning Problem	142	142
Detachment Of Device Component	142	142
Device Difficult to Setup or Prepare	126	126
Mechanical Problem	124	124
Device Handling Problem	120	120
Difficult to Advance	119	119
Fracture	114	114
Patient-Device Incompatibility	109	109
Difficult to Insert	107	107
Device Markings/Labelling Problem	98	98
Premature Activation	94	94
Optical Problem	90	90
Material Discolored	89	89
Calcified	89	89
Improper or Incorrect Procedure or Method	86	86
Unintended Ejection	84	84
Device Contaminated During Manufacture or Shipping	84	84
Difficult To Position	81	81
Activation, Positioning or Separation Problem	81	81
Migration or Expulsion of Device	80	80
Entrapment of Device	76	76
Product Quality Problem	74	74
Manufacturing, Packaging or Shipping Problem	73	73
Delivered as Unsterile Product	70	70
Sharp Edges	69	69
Material Too Rigid or Stiff	68	68
Separation Problem	67	67
Split	66	66
Detachment of Device or Device Component	63	63
Operating System Becomes Nonfunctional	63	63
Unstable	56	56
Device Appears to Trigger Rejection	49	49
Particulates	48	48
Unexpected Therapeutic Results	46	46
Material Rupture	43	43
Device Damaged Prior to Use	41	41
Component Missing	40	40
Nonstandard Device	34	34
Optical Distortion	34	34
Material Distortion	30	30
Optical Decentration	30	30
Kinked	29	29
Failure to Deliver	29	29
Structural Problem	27	27
Material Separation	27	27
Dent in Material	26	26
Inadequate Instructions for Healthcare Professional	26	26
Deformation Due to Compressive Stress	24	24
Therapeutic or Diagnostic Output Failure	24	47
Incorrect, Inadequate or Imprecise Result or Readings	22	22
Folded	21	21
Failure to Align	21	21
Device Misassembled During Manufacturing /Shipping	19	19
Incorrect Device Or Component Shipped	19	19
Sediment, Precipitate Or Deposit In Device Or Device Ingredient	18	18
Device Slipped	15	15
Hole In Material	15	15
Application Program Problem: Dose Calculation Error	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5888	5996
No Code Available	4895	4895
No Known Impact Or Consequence To Patient	3743	3928
No Patient Involvement	3330	3330
No Consequences Or Impact To Patient	2662	4234
Visual Impairment	2210	2211
Insufficient Information	1940	1973
Capsular Bag Tear	1650	1651
Blurred Vision	1611	1613
Visual Disturbances	1512	1514
Vitrectomy	1002	1002
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	757	806
Failure of Implant	613	613
Inflammation	524	524
No Information	493	493
Halo	490	490
Eye Injury	418	420
Corneal Edema	367	367
Endophthalmitis	315	315
Postoperative refraction, unexpected	255	255
Pain	188	188
Intraocular Pressure Increased	187	235
Discomfort	148	148
Loss of Vision	130	130
Dry Eye(s)	112	113
Macular Edema	102	150
Vitreous Loss	95	95
Uveitis	89	137
Rupture	89	89
Toxic Anterior Segment Syndrome (TASS)	88	88
Eye Pain	84	84
Therapeutic Effects, Unexpected	78	78
Zonular Dehiscence	76	76
Vitreous Floaters	75	76
Hemorrhage/Bleeding	75	75
Unspecified Infection	71	71
Red Eye(s)	70	70
Flashers	65	65
Complaint, Ill-Defined	63	63
Retinal Detachment	56	104
Foreign Body In Patient	55	55
Headache	54	54
Foreign Body Sensation in Eye	48	48
Iritis	48	48
Hypopyon	47	47
Glaucoma	47	47
Edema	47	47
Capsular Contracture	42	42
Hyphema	41	41
Fibrosis	39	39
Corneal Clouding/Hazing	37	37
Reaction	35	35
Unspecified Eye / Vision Problem	34	35
Swelling	32	33
Tissue Damage	28	28
Irritation	26	26
Intraocular Infection	25	25
Nausea	25	25
Excessive Tear Production	25	25
Dizziness	24	24
Vitreous Hemorrhage	24	24
Hyperemia	23	23
Diplopia	23	23
Deposits	22	22
Prolapse	22	22
Patient Problem/Medical Problem	20	20
Eye Infections	20	21
Vitreous Detachment	19	19
Injury	18	18
Bacterial Infection	18	18
Burning Sensation	17	17
Swelling/ Edema	16	16
Retinal Tear	15	15
Therapeutic Response, Decreased	15	15
Itching Sensation	14	14
Hypersensitivity/Allergic reaction	13	13
Foreign Body Reaction	13	13
Cataract	13	13
Calcium Deposits/Calcification	13	13
Corneal Decompensation	13	13
Discharge	13	13
Increased Sensitivity	13	13
Corneal Abrasion	12	12
Conjunctivitis	11	11
Erythema	11	11
Keratitis	11	11
Toxicity	11	11
Vitritis	10	10
UGH (Uveitis-Glaucoma-Hyphema) Syndrome	9	9
UGH (Uveitis Glaucoma Hyphema) Syndrome	9	9
Device Embedded In Tissue or Plaque	8	8
Altered color perception	8	8
Clouding, Central Corneal	8	8
Anxiety	8	8
High Blood Pressure/ Hypertension	8	8
Corneal Stromal Edema	7	7
Adhesion(s)	7	55
Wound Dehiscence	7	7
Disability	7	7
Intraocular Pressure Decreased	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	AMO Puerto Rico Manufacturing, Inc.	II	Aug-26-2014
2	AMO Puerto Rico Manufacturing, Inc.	II	Mar-03-2014
3	Aaren Scientific, Incorporated	II	Mar-20-2015
4	Aaren Scientific, Incorporated	III	Feb-22-2012
5	Abbott Medical Optics Inc (AMO)	II	Mar-09-2013
6	Abbott Medical Optics Inc (AMO)	II	Nov-23-2011
7	Abbott Medical Optics Inc (AMO)	II	Jan-12-2010
8	Abbott Medical Optics Inc. (AMO)	II	Sep-21-2016
9	Alcon Laboratories Ireland, Ltd	II	Jun-17-2022
10	Alcon Research LLC	II	Jun-05-2020
11	Alcon Research, Ltd.	II	Sep-01-2016
12	Alcon Research, Ltd.	I	Nov-25-2015
13	Alcon Research, Ltd.	I	Aug-07-2015
14	Bausch & Lomb Inc	II	Jan-11-2010
15	Bausch & Lomb Inc	II	Sep-09-2009
16	Bausch & Lomb Surgical, Inc.	II	Jul-10-2020
17	Bausch & Lomb Surgical, Inc.	II	Dec-18-2018
18	Bausch & Lomb Surgical, Inc.	II	Jul-20-2015
19	Bausch & Lomb Surgical, Inc.	II	Feb-20-2014
20	Hoya Surgical Optics, Inc.	II	Jul-14-2011
21	Johnson & Johnson Surgical Vision Inc	II	Nov-14-2018
22	Johnson & Johnson Surgical Vision, Inc.	II	Aug-03-2023
23	Medicel Ag	II	Aug-20-2013
24	Rayner Intraocular Lenses Limited	II	Sep-28-2018
25	Rayner Intraocular Lenses Ltd	II	Jul-06-2022
26	Staar Surgical Co.	II	Jul-17-2013
27	Staar Surgical Co.	II	Jun-29-2011
28	Tekia, Inc.	II	Dec-17-2019
29	Tekia, Inc.	II	Nov-06-2015