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The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters of addition and who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Leases are available with in monomer tint (Vat Blue 9) and with ultraviolet absorbing additive (benzophenone based):

in the power range of -20.00 to +10.00 diopters for sphere,
+0.25 to +3.00 diopters for addition
with center thickness from 0.025mm to.40mm .
with base curves of 8.00mm to 9.20mm ●
with diameter of 12.00mm to 15.00mm .

The lens material is the same as the one BIOMEDICS® UV (ocufilcon D) described in submission PMA890023/S4 and S7 ,K984046.

The Biomedics® UV Multifocal (ocufilton D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes that are presbyopic, with ar without associated ametropia, allowing for the correction of up to +3.00 diopters of add, with refractive astigmatism of no more than 0.75 diopters that does not interfere with visual acuity. The multifocal lens is a aspheric center near design.

AI/ML Overview

The medical device in question is the BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lens.

Here's an analysis of the acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices. The submission indicates that clinical studies were not necessary because the subject device was proven equivalent in material, physicochemical characteristics, parameters, and design to already approved devices. Therefore, the "performance" is implicitly deemed acceptable if it matches the established performance of the predicate devices.

Acceptance Criteria Category	Specific Criteria/Comparison Point	Predicate Device Performance	Subject Device Performance (BIOMEDICS® UV Multifocal)
Material Equivalence	Production Method	Cast molded process	Cast molded process
	Material Type	ocufilcon D (Group IV)	ocufilcon D (Group IV)
	Color Additive	Vat Blue 6 Dye	Vat Blue 6 Dye
	UV Additive	Yes	Yes
	Water Content % @ 20°C	55	55
	Refractive Index @ 20°C	1.41	1.41
	Dk (Oxygen Permeability)	19.6 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg) @ 35°C	19.6 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg) @ 35°C
	Light Transmittance (Tv, %)	97%	97%
Intended Use Equivalence	General Indication	Daily wear, correction of ametropia	Daily wear, correction of ametropia and presbyopia
	Multifocal Correction	Not applicable to spherical predicate	Up to +3.00 diopters addition, refractive astigmatism

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