TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ACCULENS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ACUITY POLYMERS, INC.
	SUBSTANTIALLY EQUIVALENT	6
BOSTON FOUNDATION FOR SIGHT, INC. D/B/A BOSTONSIGHT
	SUBSTANTIALLY EQUIVALENT	1
CONTAMAC LTD.
	SUBSTANTIALLY EQUIVALENT	1
PARAGON VISION SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN MASTERVISION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VALLEY CONTAX, INC.
	SUBSTANTIALLY EQUIVALENT	2
VISIONARY OPTICS LLC
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	2	2
2021	3	3
2022	3	3
2023	8	8
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8	8
Off-Label Use	4	4
Product Quality Problem	2	2
Labelling, Instructions for Use or Training Problem	1	1
Device Handling Problem	1	1
Insufficient Information	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Keratitis	5	5
Conjunctivitis	5	5
Corneal Ulcer	5	5
Corneal Abrasion	2	2
Iritis	1	1
Acanthameba Keratitis	1	1
Pain	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Halo	1	1
Corneal Infiltrates	1	1
Toxicity	1	1
Corneal Pannus	1	1
Corneal Edema	1	1
Corneal Scar	1	1
Hypoxia	1	1
Insufficient Information	1	1
Unspecified Eye / Vision Problem	1	1