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	5
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
ZHUHAI FITLENS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	3	3
2022	3	3
2023	8	8
2024	3	3
2025	2	2
2026	2	2

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
Device Handling Problem	2	2
Insufficient Device Problem Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	6	6
Corneal Abrasion	4	4
Keratitis	3	3
Conjunctivitis	3	3
Iritis	1	1
Halo	1	1
Eye Irritation	1	1
Unspecified Eye / Vision Problem	1	1
Insufficient Information	1	1
Corneal Edema	1	1
Infective Keratitis	1	1
Corneal Pannus	1	1
Loss of Vision	1	1
Corneal Scar	1	1
Corneal Infiltrates	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Foundation For Sight	II	Jul-29-2025