TPLC - Total Product Life Cycle

show TPLC since

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
E&E OPTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
PARAGON VISION SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
PARAGON VISION SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNERGEYES, INC.
	SUBSTANTIALLY EQUIVALENT	2
VALLEY CONTAX, INC.
	SUBSTANTIALLY EQUIVALENT	3
VISIONARY OPTICS LLC
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	14	14
Off-Label Use	4	4
Insufficient Information	3	3
Product Quality Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Patient-Device Incompatibility	2	2
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Break	1	1
Labelling, Instructions for Use or Training Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	10	10
Keratitis	6	6
Conjunctivitis	5	5
Corneal Abrasion	4	4
Corneal Edema	3	3
Acanthameba Keratitis	2	2
Pain	2	2
Discomfort	2	2
Unspecified Infection	2	2
Iritis	1	1
Toxicity	1	1
Unspecified Eye / Vision Problem	1	1
Insufficient Information	1	1
Red Eye(s)	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Halo	1	1
Corneal Infiltrates	1	1
Corneal Scar	1	1
Hyphema	1	1
Hypoxia	1	1
Corneal Pannus	1	1
Abrasion	1	1

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