Consulting Wallah › Device Explorer › Ophthalmic › Vitrectomy contact lens, single-use
Device Explorer · FDA GUDID · GMDN 58070

Vitrectomy contact lens, single-use

A 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 (

US‑registered devices74in commercial distribution
Companies10labelers on GUDID
Single‑use93%of device records
Sterile93%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Phakos2331%
Ocular Instruments, Inc.1216%
Katena Products, Inc.1014%
Fci S A S Fci 20 22811%
Volk Optical Inc.79%
Oculus Surgical Inc57%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.57%
Escalon Medical Corp.23%

Top labelers

CompanyDevicesShare
Phakos2331%
Ocular Instruments, Inc.1216%
Katena Products, Inc.1014%
Fci S A S Fci 20 22811%
Volk Optical Inc.79%
Oculus Surgical Inc57%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.57%
Escalon Medical Corp.23%
Alcon Laboratories, Inc.11%
Insight Instruments, Inc.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Alcon GrieshaberVitrectomy contact lens, single-useSINGLE USE 3 MIRRORS CONTACT LENSSUPER VIEW Lens, Disposable Contact, TornambeSUPER VIEW® Disposable Lens Set, Pivot PlusSUPER VIEW® Disposable Lens Set for RESIGHT®SUPER VIEW® Lens, Disposable Contact, Hassan-TorIrrigating Contact Lens"Contact Lens, HD Professional, Cohen-Benner, ""HD LenZ Pack for ZEISS RESIGHT®KATENA20 DEGREE PRISM LENSSURGICAL WIDE FIELD LENS WITH HANDLESURGICAL WIDE FIELD LENSPLANO LENSMAGNIFIER LENS

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HJKLens, Contact, Polymethylmethacrylate, Diagnostic68
HJKLens, contact, polymethylmethacrylate, diagnostic3
KYGDevice, Irrigation, Ocular Surgery2
HJILens, fundus, hruby, diagnostic1
LROGeneral Surgery Tray1

GMDN & GCC registration

  • GMDN code 58070 · non‑implantable
  • Single‑use 93% · sterile 93% · Rx‑only 84% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 14Angle (degree) · 3

Use these as the dimensions to specify in a tender line.

How many vitrectomy contact lens, single-use products are registered in the US?

74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vitrectomy contact lens, single-use", from 10 companies. The largest labeler is Phakos with 31% of records.

Which FDA product codes apply?

HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), HJK (Lens, contact, polymethylmethacrylate, diagnostic), KYG (Device, Irrigation, Ocular Surgery), HJI (Lens, fundus, hruby, diagnostic)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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