Phakos


Manufacturer and distributor of sterile single-use ophthalmic surgical devices and accessories since 1993, based in Montreuil, France. Activities include design and manufacture of disposable intraoperative visualization lenses, single-use surgical instruments and cryosurgery systems, on-site packaging and final inspection, and maintenance of an ISO 13485 quality management system with notified body oversight and CE conformity for multiple device families.

Industries

Health Care
Manufacturing
Medical Device
Medical Equipment Manufacturing

Nr. of Employees

small (1-50)

Phakos


Products

Single‑use vitrectomy and intraocular visualization lenses

Sterile disposable endocular visualization lenses (various optical designs) supplied in sterile double packaging for intraoperative retinal and anterior segment visualization.

Panoramic / wide‑field surgical lenses

Large field wide‑view lenses (standard and HR variants) with removable rings and optional handles for peripheral retinal viewing and treatments.

Single‑use retinal cryo probes

Sterile disposable cryo probes for retinal cryotherapy available in standard and EndFreeze variants, intended for single use.

Single‑use back‑flush needles (active/passive aspiration)

Sterile disposable back‑flush needles with brush tip for active or passive aspiration in vitreoretinal procedures, available in multiple gauges.

Single‑use gonioprism and tonometer prisms

Disposable gonioprism lenses for anterior chamber angle visualization and disposable prisms for Goldmann‑type tonometers.

Single‑use iris retractors

Sterile disposable iris retractors for pupil exposure during anterior segment surgery, supplied as multi‑piece sets.

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Expertise Areas

  • Single‑use ophthalmic device manufacturing
  • Cryosurgery system design and accessories
  • Sterile barrier packaging and validation
  • ISO 13485 quality management and notified body processes (CE/MDR)
  • Show More (3)

Key Technologies

  • PMMA ophthalmic optics
  • Cryogenic surgical systems
  • Single‑use polymer medical devices
  • Ethylene oxide (EO) sterilization processes
  • Show More (2)

News & Updates

Participation at the Société Française d'Ophtalmologie congress.

Participation at the European Society of Cataract & Refractive Surgeons congress.

Participation at the EURETINA congress.

ISO 13485 certification for quality management system covering manufacture and distribution of ophthalmic medical devices; certificate N° 11949 rev.10 (effective 03/10/2023).

CE certificates and GMED additional documents covering sterile single‑use lenses, cryo probes, back‑flush needles, iris retractors, tonometer prisms and cryosurgery systems; certificate references and product schedules are listed in notified body documentation.

Notified body confirmation letter documenting receipt of formal application and signed written agreement under MDR transitional provisions (reference: 39594 rev.0, 22/02/2024).

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