Eyelid weight, implantable

FDA UDI

Class I (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name: Eyelid weight, implantable FDA UDI
Generic Name: Eyelid weight, implantable FDA UDI
Device Name: An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)]. FDA UDI
Model / Reference: PTOSE-UP 2 mm WIDTH J.M. RUBAN M.D. FDA UDI
Description: An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)]. FDA UDI

Identifiers

Catalog Number: S3.3021u FDA UDI
Primary DI / UDI-DI: 03760087120806 FDA UDI
FDA Product Code: HJZ FDA UDI
GMDN Term: Eyelid weight, implantable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.5600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

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

Yes

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: Length — 150 Millimeter FDA UDI

Category: Eyelid weight, implantable

Eyelid weight, implantable by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eyelid weight, implantable.

ThinProfile Gold Eyelid Weight Implant — MEDDEV CORPORATION · Class II
Labtician Lid Load™ 1.4 grams — Labtician Ophthalmics, Inc · Class II
Contour Gold Eyelid Weight Implant — MEDDEV CORPORATION · Class II
Labtician Lid Load™ 2.0 grams — Labtician Ophthalmics, Inc · Class II
Tantalum Weight 2.2 gram Pink — Labtician Ophthalmics, Inc · Class II
Tantalum Weight 1.2 gram — Labtician Ophthalmics, Inc · Class II
JEDMED — JEDMED Instrument Company · Class II
Upper Eyelid Implant Platinum/Iridium — Heinz Kurz · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Fci S A S Fci 20 22

Sources (1)

FDA UDI 001ec056-2e5e-4f1e-b0c7-69f0a7efb8f7 36 fields · synced May 31, 2026