Lenses, Soft Contact, Extended Wear

Device Code: 4332

Product Code(s): LPM

Device Classification Information

Device Type ID	4332
Device Name	Lenses, Soft Contact, Extended 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	PMA
CFR Regulation Number	886.5925 [🔎]
FDA Device Classification	Class 3 Medical Device
Product Code	LPM
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

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	4332
Device	Lenses, Soft Contact, Extended Wear
Product Code	LPM
FDA Device Classification	Class 3 Medical Device
Regulation Description	Soft (hydrophilic) Contact Lens.
CFR Regulation Number	886.5925 [🔎]

Device Problems
Contact Lens	476
No Apparent Adverse Event	365
Adverse Event Without Identified Device Or Use Problem	230
Insufficient Information	10
Appropriate Term/Code Not Available	2
Use Of Device Problem	2
Contamination During Use	2
Improper Or Incorrect Procedure Or Method	1
Device Operates Differently Than Expected	1
Contamination / Decontamination Problem	1
Missing Value Reason	1
Defective Device	1
Torn Material	1
Sticking	1
Total Device Problems	1094

Recalls
Manufacturer		Recall Class	Date Posted
1	Cooper Vision Caribbean Corp.	II	Dec-15-2014
2	CooperVision Inc.	III	Feb-23-2018
3	Intertrade Imports Inc.	II	Jan-12-2015
4	Johnson & Johnson Vision Care, Inc.	II	Mar-27-2018

TPLC Last Update: 2019-04-02 20:47:08