FDA.reportPublic FDA data

FINEVISION HP Trifocal IOL

Primary DI
05414846625436
Brand
FINEVISION HP Trifocal IOL
Company
Physiol
Model
POD F GF +16.0 D
Catalog number
36092160A
Device description
The FINEVISION HP Trifocal IOL is a foldable, ultraviolet and blue light filtering multifocal intraocular lens intended for implantation in the posterior chamber capsular bag to correct aphakia following cataract removal, providing trifocal vision at distance, intermediate (+1.75 D add), and near (+3.50 D add). The single-piece biconvex optic (6.0 mm diameter) with aspheric anterior surface and double C-loop haptics (11.4 mm overall diameter) is made of proprietary high refractive index hydrophobic acrylic material.
Published
2025-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens
MFKLens, Multifocal Intraocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3
MFKLens, Multifocal IntraocularOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240038000FINEVISION HP Trifocal IOLsBeaver Visitec International, Inc.2025-09-10HQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414846625436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414846625436054148466254365414846625436

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
298385592
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414846625313FINEVISION HP Trifocal IOLPOD F GF +10.0 D36092100A2025-12-15
05414846625320FINEVISION HP Trifocal IOLPOD F GF +10.5 D36092105A2025-12-15
05414846625337FINEVISION HP Trifocal IOLPOD F GF +11.0 D36092110A2025-12-15
05414846625344FINEVISION HP Trifocal IOLPOD F GF +11.5 D36092115A2025-12-15
05414846625351FINEVISION HP Trifocal IOLPOD F GF +12.0 D36092120A2025-12-15
05414846625368FINEVISION HP Trifocal IOLPOD F GF +12.5 D36092125A2025-12-15
05414846625375FINEVISION HP Trifocal IOLPOD F GF +13.0 D36092130A2025-12-15
05414846625382FINEVISION HP Trifocal IOLPOD F GF +13.5 D36092135A2025-12-15
05414846625399FINEVISION HP Trifocal IOLPOD F GF +14.0 D36092140A2025-12-15
05414846625405FINEVISION HP Trifocal IOLPOD F GF +14.5 D36092145A2025-12-15
05414846625412FINEVISION HP Trifocal IOLPOD F GF +15.0 D36092150A2025-12-15
05414846625429FINEVISION HP Trifocal IOLPOD F GF +15.5 D36092155A2025-12-15
05414846625443FINEVISION HP Trifocal IOLPOD F GF +16.5 D36092165A2025-12-15
05414846625450FINEVISION HP Trifocal IOLPOD F GF +17.0 D36092170A2025-12-15
05414846625467FINEVISION HP Trifocal IOLPOD F GF +17.5 D36092175A2025-12-15
05414846625474FINEVISION HP Trifocal IOLPOD F GF +18.0 D36092180A2025-12-15
05414846625481FINEVISION HP Trifocal IOLPOD F GF +18.5 D36092185A2025-12-15
05414846625498FINEVISION HP Trifocal IOLPOD F GF +19.0 D36092190A2025-12-15
05414846625504FINEVISION HP Trifocal IOLPOD F GF +19.5 D36092195A2025-12-15
05414846625511FINEVISION HP Trifocal IOLPOD F GF +20.0 D36092200A2025-12-15

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Primary DI, Brand, Company table
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