FDA.reportPublic FDA data

SUPER VIEW Lens, Disposable Contact, Tornambe

Primary DI
10856222004206
Brand
SUPER VIEW Lens, Disposable Contact, Tornambe
Company
OCULUS SURGICAL INC
Model
40413
Catalog number
40413
Device description
SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
Published
2024-08-13
Public version status
New
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
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051630000SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.2005-06-29HJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856222004206PackageGS110In Commercial Distribution
00856222004209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085622200420610856222004206
00856222004209008562220042098562220042090856222004209

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy contact lens, single-useA sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter13Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
772-236-2622info@oculussurgical.com

Regulatory Flags#

DUNS number
015409582
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856222004025SUPER VIEW® Pack40211402112016-09-23
00856222004728HD LenZ Pack Plus, for ZEISS RESIGHT®54019540192020-11-24
00856222004018SUPER VIEW® Pack40213402132016-09-23
00856222004209SUPER VIEW Lens, Disposable Contact, Tornambe40413404132024-08-13
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®40240402402020-11-24
00852475007103HD LenZ Pack for ZEISS RESIGHT®54010540102020-11-24
00852475007127BIOM Optic Set, HD Professional, for f=175mm54021540212022-02-15
00852475007141BIOM Optic Set, HD Professional, for f=200mm54022540222022-02-15
00852475007165HD Disposable, LenZ54026540262022-02-15
00852475007240Versa Optic Set, for f=200mm54212542122022-01-25
00852475007264VERSA HD Disposable LenZ542162020-12-04
00856222004056SUPER VIEW® Disposable Lens Set, Essential40403404032016-09-23
00856222004179SUPER VIEW® Disposable Lens Set, Pivot Plus40227402272016-09-23
00856222004544SUPER VIEW® Disposable HD Lens Set for RESIGHT®40220402202020-11-24
00856222004551SUPER VIEW Pack, HD, Disposable, for ZEISS RESIGHT®54018540182020-11-24
00856222004742SUPER VIEW® Disposable Lens Set, Pivot40223402232016-09-23
00852475007158BIOM Optic Set, HD Flex54025540252022-02-15
00852475007219Versa Optic Set, for f=175mm54211542112022-01-25
00852475007080Super View® Pack, Pivot Plus (40101+40227)40229402292020-11-24
00852475007189Super View® Lens Set, Disposable, Pivot, for BIOM ml/cl54014540142020-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668123942KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144466KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144473KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668123949KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144463KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144470KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00818806021774RxSight Contact LensRXSIGHT, INC.HJK2025-09-05
00811608014869Capsulotomy (VLUCAPS)VOLK OPTICAL INC.HJK2025-01-29
00811608015934Iridectomy (VLUIRID)VOLK OPTICAL INC.HJK2025-01-29
00856222004209SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
00811608014654Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
10811608014675Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
03760087122343SINGLE USE 3 MIRRORS CONTACT LENSFCI S A S FCI 20 22HJK2021-05-30
00852475007202"Contact Lens, HD Professional, Cohen-Benner, ""CBC"""OCULUS SURGICAL INCHJK2021-02-26
10852475007209Contact Lens, HD Professional, Cohen-Benner, "CBC"OCULUS SURGICAL INCHJK2021-02-26
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00852475007059SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00818806020531RxSight Contact LensRXSIGHT, INC.HJK2020-10-16
03760087122176Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122190Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122206Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122213Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123685Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123692Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123708Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122171Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122195Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122201Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122218Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087123680Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06