Lenses, Soft Contact, Daily Wear

Device Code: 4331

Product Code(s): LPL

Device Classification Information

Device Type ID	4331
Device Name	Lenses, Soft Contact, Daily Wear
Regulation Description	Soft (hydrophilic) Contact Lens.
Regulation Medical Specialty	Ophthalmic
Review Panel	Ophthalmic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD)
Submission Type	510(k)
CFR Regulation Number	886.5925 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	LPL
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Recognized Standards

10-60 ISO 11981 Second Edition 2009-07-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Physical Compatibility Of Contact Lens Care Products With Contact Lenses
10-67 ISO 11986 Second Edition 2010-11-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Guidelines For Determination Of Preservation Uptake And Release
10-77 ISO 9394 Third Edition 2012-10-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Biocompatibility By Ocular Study With Rabbit Eyes
10-85 ISO 11980 Third Edition 2012-11-15 Corrected Version 2012-12-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Guidance For Clinical Investigations
10-87 ASTM D882-12
Standard Test Methods For Tensile Properties Of Thin Plastic Sheeting
10-100 ISO 18259 First Edition 2014-10-01
Ophthalmic Optics - Contact Lens Care Products - Method To Assess Contact Lens Care Products With Contact Lenses In A Lens Case, Challenged With Bacterial And Fungal Organisms
10-101 ISO 18189 First Edition 2016-06-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Cytotoxicity Testing Of Contact Lenses In Combination With Lens Care Solution To Evaluate Lens/solution Interactions
10-104 ANSI Z80.20-2016
American National Standard For Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements And Physicochemical Properties
10-106 ISO 18369-3 Second Edition 2017-08
Ophthalmic Optics - Contact Lenses - Part 3: Measurement Methods
10-107 ISO 18369-4 Second Edition 2017-08
Ophthalmic Optics - Contact Lenses - Part 4: Physicochemical Properties Of Contact Lens Materials
10-108 ISO 18369-2 Third Edition 2017-08
Ophthalmic Optics - Contact Lenses - Part 2: Tolerances
10-109 ISO 18369-1 Second Edition 2017-08
Ophthalmic Optics - Contact Lenses - Part 1: Vocabulary, Classification System And Recommendations For Labelling Specifications
10-111 ISO 11981 Third Edition 2017-11
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Physical Compatibility Of Contact Lens Care Products With Contact Lenses
10-112 ISO 11986 Third Edition 2017-11
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Preservative Uptake And Release

Total Product Life Cycle

Device Type ID	4331
Device	Lenses, Soft Contact, Daily Wear
Product Code	LPL
FDA Device Classification	Class 2 Medical Device
Regulation Description	Soft (hydrophilic) Contact Lens.
CFR Regulation Number	886.5925 [🔎]

Premarket Reviews
Manufacturer	Decision
ALCON
	SUBSTANTIALLY EQUIVALENT	14
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALCON RESEARCH, LTD.
	SUBSTANTIALLY EQUIVALENT	14
ART OPTICAL CONTACT LENS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	3
CIBA VISION
	SUBSTANTIALLY EQUIVALENT	1
COOPERVISION
	SUBSTANTIALLY EQUIVALENT	2
COOPERVISION, INC.
	SUBSTANTIALLY EQUIVALENT	3
EYEYON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
FIRESTONE OPTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GELFLEX LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
INTEROJO INC.
	SUBSTANTIALLY EQUIVALENT	2
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	3
JOHNSON & JOHNSON VISION CARE, INC.
	SUBSTANTIALLY EQUIVALENT	3
JOOWON INNOVATION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LARGAN MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	3
MENICON CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
NEO VISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PEGAVISION CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
POLYDEV LTD.
	SUBSTANTIALLY EQUIVALENT	3
QUALIMED SRL
	SUBSTANTIALLY EQUIVALENT	2
SAUFLON PHARMACEUTICALS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEINOH OPTICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOUFLON PHARMACEUTICALS LTD
	SUBSTANTIALLY EQUIVALENT	1
ST. SHINE OPTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNICON OPTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNILENS CORP., USA
	SUBSTANTIALLY EQUIVALENT	1
VALEANT PHARMACEUTICALS
	SUBSTANTIALLY EQUIVALENT	1
VASSEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VISCO TECHNOLOGY SDN. BHD
	SUBSTANTIALLY EQUIVALENT	2
VISCO VISION INC.
	SUBSTANTIALLY EQUIVALENT	2
VISION SCIENCE CO LTD
	SUBSTANTIALLY EQUIVALENT	1
YUNG SHENG OPTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Contact Lens	346
No Apparent Adverse Event	196
Adverse Event Without Identified Device Or Use Problem	123
Insufficient Information	31
Device Operates Differently Than Expected	8
Torn Material	6
Patient-Device Incompatibility	5
Appropriate Term/Code Not Available	4
Improper Or Incorrect Procedure Or Method	3
Disposable	2
Use Of Device Problem	2
Component Missing	2
Break	2
Naturally Worn	2
Packaging Problem	1
Defective Device	1
Material Rupture	1
Sticking	1
Material Integrity Problem	1
Product Quality Problem	1
Difficult To Remove	1
Total Device Problems	739

Recalls
Manufacturer		Recall Class	Date Posted
1	Alden Optical	II	Mar-13-2018
2	Bausch & Lomb Inc Irb	II	Nov-04-2015
3	Ciba Vision Corporation	II	Jun-25-2015
4	Cooper Vision Caribbean Corp.	III	Oct-24-2014
5	Johnson & Johnson Vision Care, Inc.	II	Aug-23-2018
6	Johnson & Johnson Vision Care, Inc.	II	Mar-27-2018
7	The See Clear Company	II	Mar-03-2017

TPLC Last Update: 2019-04-02 20:47:06