TPLC - Total Product Life Cycle

• Device: accessories, soft lens products
• Product Code: LPN
• Regulation Number: 886.5928
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
ALLERGAN, INC
	SUBSTANTIALLY EQUIVALENT	1
BAUSCH & LOMB INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
CHEMTEX USA INC.
	SUBSTANTIALLY EQUIVALENT	1
CHEMTEX USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MENICON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MENICON CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
OPTICS LABORATORY, INC.
	SUBSTANTIALLY EQUIVALENT	1
OTE NORTH AMERICA LLC
	SUBSTANTIALLY EQUIVALENT	1
THE LIFESTYLE COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	105	105
2015	176	176
2016	498	498
2017	2665	2665
2018	95	95
2019	60	60
2020	82	82
2021	50	50
2022	62	62
2023	85	85
2024	62	64

Device Problems	MDRs with this Device Problem	Events in those MDRs
Product Quality Problem	2897	2897
Adverse Event Without Identified Device or Use Problem	396	397
Improper or Incorrect Procedure or Method	119	119
Insufficient Information	78	78
Device Operates Differently Than Expected	73	73
Device Markings/Labelling Problem	65	65
Patient-Device Incompatibility	54	54
Inadequate Instructions for Non-Healthcare Professional	33	33
Device Emits Odor	32	32
Contamination	32	32
Packaging Problem	28	28
Use of Device Problem	27	27
Labelling, Instructions for Use or Training Problem	17	17
Material Integrity Problem	17	17
Appropriate Term/Code Not Available	17	17
Leak/Splash	12	12
Device Handling Problem	11	11
Off-Label Use	8	8
Contamination /Decontamination Problem	8	8
Manufacturing, Packaging or Shipping Problem	6	6
No Apparent Adverse Event	5	5
Device Contamination with Chemical or Other Material	5	5
Nonstandard Device	5	5
Patient Device Interaction Problem	5	5
Microbial Contamination of Device	5	5
Device Expiration Issue	5	5
Defective Device	4	4
Improper Chemical Reaction	4	4
Break	4	4
Crack	4	4
Contamination of Device Ingredient or Reagent	4	4
Protective Measures Problem	3	3
Fungus in Device Environment	3	3
Unexpected Therapeutic Results	3	3
Output Problem	3	3
Incomplete or Missing Packaging	3	3
Fluid/Blood Leak	3	3
Expiration Date Error	2	2
Difficult to Remove	2	2
Defective Component	2	2
Component Missing	2	2
Inadequate User Interface	2	2
Inappropriate or Unexpected Reset	2	2
Chemical Problem	2	2
Device Reprocessing Problem	1	1
Naturally Worn	1	1
Failure to Disinfect	1	1
Loose or Intermittent Connection	1	1
Inaccurate Dispensing	1	1
Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	2815	2815
Red Eye(s)	549	549
Pain	390	390
Irritation	344	344
Discomfort	176	177
Blurred Vision	151	151
Excessive Tear Production	149	149
Eye Burn	106	106
Keratitis	100	100
Corneal Ulcer	100	100
Conjunctivitis	97	98
Swelling	95	95
Dry Eye(s)	80	80
No Consequences Or Impact To Patient	74	74
No Code Available	74	74
Itching Sensation	73	73
Corneal Abrasion	63	63
Eye Pain	57	58
Inflammation	56	56
Caustic/Chemical Burns	56	56
Unspecified Infection	56	56
Eye Injury	52	52
Loss of Vision	46	46
Hyperemia	45	46
No Known Impact Or Consequence To Patient	45	45
Erythema	43	43
Foreign Body Sensation in Eye	37	37
Visual Disturbances	35	35
Visual Impairment	34	34
Reaction	34	34
No Clinical Signs, Symptoms or Conditions	30	30
Chemical Exposure	29	29
Burn(s)	28	28
Eye Infections	27	27
Corneal Edema	27	27
Corneal Scar	26	26
Headache	23	23
Discharge	22	22
Hypersensitivity/Allergic reaction	16	17
Corneal Clouding/Hazing	16	16
Increased Sensitivity	16	16
Erosion	15	15
Corneal Infiltrates	15	15
Acanthameba Keratitis	14	14
Fungal Infection	14	14
No Patient Involvement	14	14
Swelling/ Edema	12	12
Bacterial Infection	12	12
Halo	12	12
Complaint, Ill-Defined	12	12

Recalls
Manufacturer		Recall Class	Date Posted
1	Allergan PLC	II	Feb-03-2021
2	Bausch & Lomb Inc Irb	II	Nov-21-2016
3	Family Dollar Stores, Llc.	II	Aug-17-2022
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022