Raindrop Near Vision Inlay

Primary DI
10850394006013
Brand
Raindrop Near Vision Inlay
Company
REVISION OPTICS, INC.
Model
RD1-1
Catalog number
RD1-1
Device description
The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only.
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LQEImplant, Corneal, Refractive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQEImplant, Corneal, RefractiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150034000Raindrop Near Vision InlayRvo 2.0, Inc. (D.B.A. Optics Medical)2016-06-29LQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850394006010PackageGS14In Commercial Distribution
10850394006013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085039400601020850394006010
1085039400601310850394006013

GMDN Terms#

Term, Definition table
TermDefinition
Corneal inlay, aperture reducingA sterile implantable device inserted into the natural cornea to treat presbyopia [age-related hyperopia (far sightedness)] based on aperture reduction. It is typically made of plastic material and is shaped as a thin annulus (disc) formed to fit the curvature of the cornea; it includes a central opening that restricts the optical aperture of the eye to increase depth of field. It is intended for long-term implantation and is surgically inserted in an intrastromal pocket or flap made by a keratome or an appropriate laser.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
909-747-2740customerservice@revisionoptics.com

Regulatory Flags#

DUNS number
015504442
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850394006051Inlay Inserter Chuck Handle607-0002607-00022016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850048576100Intacs for Keratoconus, Symmetric 0.210 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576117Intacs for Keratoconus, Symmetric 0.250 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576124Intacs for Keratoconus, Symmetric 0.300 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576131Intacs for Keratoconus, Symmetric 0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576148Intacs for Keratoconus, Symmetric 0.400 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576155Intacs for Keratoconus, Symmetric 0.450 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576162Intacs for Keratoconus, Asymmetric 0.210/0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576179Intacs for Keratoconus, Asymmetric 0.210/0.400 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576186Intacs for Keratoconus, Asymmetric 0.210/0.450 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576193Intacs for Myopia, Symmetric 0.250 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576209Intacs for Myopia, Symmetric 0.300 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00850048576216Intacs for Myopia, Symmetric 0.350 mmADDITION TECHNOLOGY, INC.LQE2023-06-13
00813359020052KAMRA inlayBausch & Lomb IncorporatedLQE2017-01-13
00813359020045KAMRA inlayBausch & Lomb IncorporatedLQE2017-01-05
10850394006051Inlay Inserter Chuck HandleREVISION OPTICS, INC.LQE2016-08-19
00866304000104Intacs Corneal ImplantsADDITION TECHNOLOGY, INC.LQE2015-06-30
00813359020007KAMRA inlayBausch & Lomb IncorporatedLQE2015-04-29