Consulting Wallah › Device Explorer › Ophthalmic › Posterior-chamber intraocular lens, pseudophakic
Device Explorer · FDA GUDID · GMDN 35658

Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace

US‑registered devices27,708in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Alcon Laboratories, Inc.10,09436%
Eyekon Medical, Inc.7,52727%
Johnson & Johnson Surgical Vision, Inc.4,46916%
Bausch & Lomb Incorporated3,08611%
Rayner Intraocular Lenses Limited7523%
Hoya Medical Singapore Pte. Ltd.6222%
Lenstec Barbados Inc4542%
Staar Surgical Company2591%

Top labelers

CompanyDevicesShare
Alcon Laboratories, Inc.10,09436%
Eyekon Medical, Inc.7,52727%
Johnson & Johnson Surgical Vision, Inc.4,46916%
Bausch & Lomb Incorporated3,08611%
Rayner Intraocular Lenses Limited7523%
Hoya Medical Singapore Pte. Ltd.6222%
Lenstec Barbados Inc4542%
Staar Surgical Company2591%
Carl Zeiss Meditec Production, Llc1911%
Aaren Scientific Inc.1220%
Rxsight, Inc.820%
Physiol490%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FINEVISION HP Trifocal IOLSMARTLOADPURESEE IOLTECNIS ODYSSEY TORIC II IOLTECNIS ODYSSEY IOLTECNIS IOLTECNIS SIMPLICITYSENSAR IOLTECNIS CL IOLREZOOM IOLCLARIFLEXC-flex Aspheric Hydrophilic Acrylic Injectable IC-flex Hydrophilic Acrylic Injectable IOL600C Aspheric Intraocular LensRayOne AsphericRayOne Spheric

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

FDA product codes

CodeNameDevices
HQLIntraocular Lens13,410
HQLintraocular lens6,592
MFKLens, Multifocal Intraocular2,485
MFKLens, multifocal intraocular2,171
MJPLens, Intraocular, Toric Optics2,095
MJPLENS, INTRAOCULAR, TORIC OPTICS2,094

GMDN & GCC registration

  • GMDN code 35658 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 93% · 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) · 6,438Length (Millimeter) · 1,631

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

How many posterior-chamber intraocular lens, pseudophakic products are registered in the US?

27,708 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Posterior-chamber intraocular lens, pseudophakic", from 13 companies. The largest labeler is Alcon Laboratories, Inc. with 36% of records.

Which FDA product codes apply?

HQL (Intraocular Lens), HQL (intraocular lens), MFK (Lens, Multifocal Intraocular), MFK (Lens, multifocal intraocular)

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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