Vitrectomy contact lens, single-use

FDA UDI

Class II (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name: Vitrectomy contact lens, single-use FDA UDI
Generic Name: Vitrectomy contact lens, single-use FDA UDI
Device Name: 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 (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device. FDA UDI
Model / Reference: DISPOSABLE PMMA BICONCAVE LENS FDA UDI
Description: 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 (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device. FDA UDI

Identifiers

Catalog Number: S5.8040U FDA UDI
Primary DI / UDI-DI: 03760087123692 FDA UDI
FDA Product Code: HJK FDA UDI
GMDN Term: Vitrectomy contact lens, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1385 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 11.25 Millimeter FDA UDI

Category: Vitrectomy contact lens, single-use

Vitrectomy contact lens, single-use by Fci S A S Fci 20 22 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fci S A S Fci 20 22

Sources (1)

FDA UDI 87e91961-8d5d-4c33-a035-0ca044a07bad 35 fields · synced May 30, 2026