TPLC - Total Product Life Cycle

• Device: lens, contact (other material) - daily
• Product Code: HQD
• Regulation Number: 886.5916
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCULENS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ACUITY POLYMERS, INC.
	SUBSTANTIALLY EQUIVALENT	10
ADVANCED VISION TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
ART OPTICAL CONTACT LENS INC
	SUBSTANTIALLY EQUIVALENT	1
BAUSCH & LOMB, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
BAUSCH + LOMB INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
BOSTON FOUNDATION FOR SIGHT
	SUBSTANTIALLY EQUIVALENT	1
BOSTONSIGHT
	SUBSTANTIALLY EQUIVALENT	2
CONTAMAC LTD.
	SUBSTANTIALLY EQUIVALENT	6
1.  K161100  Optimum GP with HPT (roflufocon A, B, C, D, and E) ...
2.  K171077  HEXA100 (hexafocon A) Daily Wear Contact Lenses
3.  K171575  ENFLU 18 (enflufocon A) Daily Wear Contact Lens
4.  K180616  OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear ...
5.  K182304  Hyper GP (tisilfocon A) Daily Wear Contact Lens
6.  K212631  Optimum Infinite (tisilfocon A) Daily Wear Contact ...
E&E OPTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
PARAGON VISION SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
PARAGON VISION SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNERGEYES, INC.
	SUBSTANTIALLY EQUIVALENT	3
VALLEY CONTAX, INC.
	SUBSTANTIALLY EQUIVALENT	3
VISIONARY OPTICS LLC
	SUBSTANTIALLY EQUIVALENT	3

MDR Year	MDR Reports	MDR Events
2014	26	26
2015	5	5
2016	1	1
2017	3	3
2019	5	5
2020	2	2
2021	3	3
2022	3	3
2023	8	8
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	28	28
Appropriate Term/Code Not Available	12	12
Insufficient Information	5	5
Off-Label Use	4	4
Product Quality Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Patient-Device Incompatibility	2	2
Difficult to Remove	1	1
Break	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Abrasion	16	16
Corneal Ulcer	15	15
Keratitis	6	6
Conjunctivitis	5	5
Corneal Edema	4	4
Red Eye(s)	3	3
Corneal Infiltrates	3	3
Discomfort	2	2
Pain	2	2
No Code Available	2	2
Acanthameba Keratitis	2	2
Unspecified Infection	2	2
Intraocular Infection	2	2
Iritis	2	2
Neovascularization	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Halo	1	1
Corneal Scar	1	1
Corneal Pannus	1	1
Abrasion	1	1
Macular Edema	1	1
Eye Injury	1	1
Hyphema	1	1
Hypoxia	1	1
Unspecified Eye / Vision Problem	1	1
Insufficient Information	1	1
Toxicity	1	1
Injury	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alden Optical	III	Sep-06-2018