Accessories, Soft Lens Products

Device Code: 4333

Product Code(s): LPN

Device Classification Information

Device Type ID	4333
Device Name	Accessories, Soft Lens Products
Regulation Description	Soft (hydrophilic) Contact Lens Care Products.
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	886.5928 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	LPN
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
10-86 ISO 14729 First Edition 2001-04-15
Ophthalmic Optics - Contact Lens Care Products - Microbiological Requirements And Test Methods For Products And Regimens For Hygienic Management Of Contact Lenses [Including: Amendment 1 (2010]
10-99 ISO 4311 First Edition 1979-06-01
Anionic And Non-ionic Surface Active Agents - Determination Of Critical Micellization Concentration - Method By Measuring Surface Tension With A Plate, Stirrup, Or Ring
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
10-103 ANSI Z80.18-2016
American National Standard For Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, And Test Methodology
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	4333
Device	Accessories, Soft Lens Products
Product Code	LPN
FDA Device Classification	Class 2 Medical Device
Regulation Description	Soft (hydrophilic) Contact Lens Care Products.
CFR Regulation Number	886.5928 [🔎]

Premarket Reviews
Manufacturer	Decision
ALCON
	SUBSTANTIALLY EQUIVALENT	2
ALCON RESEARCH, LTD.
	SUBSTANTIALLY EQUIVALENT	2
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	2
OPTICS LABORATORY, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Product Quality Problem	2873
Adverse Event Without Identified Device Or Use Problem	158
Device Operates Differently Than Expected	24
Use Of Device Problem	13
Device Markings / Labelling Problem	12
Improper Or Incorrect Procedure Or Method	8
Appropriate Term/Code Not Available	6
Insufficient Information	6
Leak / Splash	6
No Apparent Adverse Event	5
Contact Lens	5
Contamination During Use	5
Device Contamination With Chemical Or Other Material	4
Device Emits Odor	3
Crack	3
Device Expiration Issue	3
Unexpected Therapeutic Results	3
Contamination / Decontamination Problem	3
Incomplete Or Missing Packaging	2
Device Handling Problem	1
Failure To Obtain Sample	1
Pumping Stopped	1
Microbial Contamination Of Device	1
Inadequate Instructions For Non-Healthcare Professional	1
Naturally Worn	1
Fungus In Device Environment	1
Degraded	1
Difficult To Remove	1
Patient-Device Incompatibility	1
Total Device Problems	3152

Recalls
Manufacturer		Recall Class	Date Posted
1	Bausch & Lomb Inc Irb	II	Nov-21-2016

TPLC Last Update: 2019-04-02 20:47:10