Consulting Wallah › Device Explorer › Other devices › Phacoemulsification/vitrectomy system
Device Explorer · FDA GUDID · GMDN 45072

Phacoemulsification/vitrectomy system

An assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing p

US‑registered devices63in commercial distribution
Companies6labelers on GUDID
Single‑use38%of device records
Sterile38%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Bausch & Lomb Incorporated3759%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.2032%
Alcon Laboratories, Inc.23%
Oertli-Instrumente Ag23%
Carl Zeiss Meditec Ag12%
Carl Zeiss Meditec, Cataract Technology, Inc.12%

Top labelers

CompanyDevicesShare
Bausch & Lomb Incorporated3759%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.2032%
Alcon Laboratories, Inc.23%
Oertli-Instrumente Ag23%
Carl Zeiss Meditec Ag12%
Carl Zeiss Meditec, Cataract Technology, Inc.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

QUATERA 700MICOR Auto I/ABausch + LombStellarisUNITYEVA NEXUS™, Phaco vitrectomy system including laEVA NEXUS™, Phaco vitrectomy system including laEVA NEXUS™, Phaco vitrectomy systemEVA NEXUS™, Phaco emulsification systemEVA NEXUS™ Digital Overlay SystemEVA, combined machine including Laser (SMA conneEVA, combined machine including Laser (DORC connEVA, combined machineEVA, anterior machineEVA Flight Case. Accessory to EVA.Safety filter for Leica Microscopes, Passive

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

FDA product codes

CodeNameDevices
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered51
HQCUnit, Phacofragmentation43
HQFLaser, Ophthalmic22
MLZVitrectomy, Instrument Cutter1

GMDN & GCC registration

  • GMDN code 45072 · non‑implantable
  • Single‑use 38% · sterile 38% · Rx‑only 100% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many phacoemulsification/vitrectomy system products are registered in the US?

63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Phacoemulsification/vitrectomy system", from 6 companies. The largest labeler is Bausch & Lomb Incorporated with 59% of records.

Which FDA product codes apply?

HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), HQC (Unit, Phacofragmentation), HQF (Laser, Ophthalmic), MLZ (Vitrectomy, Instrument Cutter)

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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