Implant, Eye Sphere

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K781356 ↗

FDA Product Code

HPZ

Device Class

Class II

Regulation

21 CFR Part 886.3320

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Ionotphoretic Applicator

  Class II

  FDA 510(k) K781700 Active Cleared 3 Nov 1978

• Mcghan Tissue Expander

  Unclassified

  FDA 510(k) K843704 Active Cleared 31 Oct 1984

• Mcghan Tissue Expander Fill Kit Open recall

  Unclassified

  FDA 510(k) K853014 Active Cleared 18 Sep 1985

• Otological Ventilation Tubes

  Class II

  FDA 510(k) K780956 Active Cleared 22 Jun 1978

• Mcghan Longterm Mammary Expander/Gel-Saline Design

  Unclassified

  FDA 510(k) K864184 Active Cleared 24 Dec 1986

• Micro-Torque Hand Engine & Access. Dermabra. Burs

  Class I

  FDA 510(k) K873475 Active Cleared 11 Sep 1987

See all devices from Mcghan Medical Corp. →

• What is the Implant, Eye Sphere designed for?

  The Implant, Eye Sphere is intended to replace or augment the natural eye sphere in procedures like aphakia management (absence of the eye lens) or orbital reconstruction. It provides structural support where the eye’s spherical shape is lost or compromised, restoring form and function in controlled clinical settings.

• How is the Implant, Eye Sphere supplied and prepared for use?

  The device is supplied as a sterile, single-use implant. This ensures sterility is maintained for one procedure only, reducing infection risks. Clinicians must follow sterile technique protocols during handling and implantation, as reuse is not permitted.

• Are there different sizes available for the Implant, Eye Sphere?

  Yes, sizes are determined by the patient’s specific surgical requirements and anatomical measurements. The implant is designed to match the patient’s ocular or orbital dimensions precisely, allowing for tailored reconstruction or support.

• Can the Implant, Eye Sphere be used in MRI environments?

  The Implant, Eye Sphere is not inherently MRI-safe unless explicitly stated in accompanying documentation. Clinicians should verify compatibility with their MRI system and consult manufacturer guidelines before use in magnetic resonance imaging.

• Who can perform procedures using the Implant, Eye Sphere?

  The device is intended for use in controlled clinical settings by trained ophthalmic professionals. Only qualified surgeons with experience in ocular or orbital reconstruction should handle and implant this device to ensure proper technique and patient outcomes.