Model Ac (AC1-AC5)

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

intraocular lens

PMA Number

P810001 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

• Alcon Vision System

  Class II

  FDA 510(k) K063583 Active Cleared 9 May 2008

• Opti-Free Express Multi-Purpose Solution

  Class II

  FDA 510(k) K981574 Active Cleared 6 Jul 1998

• Inteliport Occluding Device

  Unclassified

  FDA 510(k) K040231 Active Cleared 13 Jul 2004

• Soft (Hydrophilic) Contact Lens Care Solution

  Class II

  FDA 510(k) K031193 Active Cleared 3 Jul 2003

• Alcon Multi-Purpose Solution

  Class II

  FDA 510(k) K071236 Active Cleared 12 Dec 2007

• Models 1S & 1P Intraocular Lens

  Class III

  FDA PMA P800049 Active Approved 31 Mar 1983

See all devices from Alcon →

• What is the primary purpose of the Model AC Intraocular Lens (AC1–AC5) and how is it implanted?

  The Model AC Intraocular Lens (AC1–AC5) is designed to replace the natural crystalline lens during cataract surgery, restoring visual function after lens extraction. It is a foldable, posterior chamber intraocular lens that must be implanted by a trained ophthalmic surgeon in a sterile operating environment. The device is specifically intended for use in the eye and requires careful handling to ensure safety and compliance with FDA guidelines.

• Are the Model AC Intraocular Lenses (AC1–AC5) reusable or single-use, and how are they supplied?

  The Model AC Intraocular Lenses (AC1–AC5) are intended for **single-use only** and are supplied sterile by Alcon. Each lens is packaged to maintain sterility until implantation, ensuring safety and compliance with medical standards for ocular procedures.

• What regulatory pathway does the Model AC Intraocular Lens (AC1–AC5) follow, and what approval number is associated with it?

  The Model AC Intraocular Lens (AC1–AC5) follows the **FDA Premarket Approval (PMA)** pathway, classified as a **Class III** device. It holds approval number **P810001** with a supplement (S004). This regulatory route ensures rigorous evaluation before clinical use, as required for high-risk medical devices like intraocular lenses.

• What models are available for the Model AC Intraocular Lens, and how do they differ?

  The Model AC Intraocular Lens is available in five models: **AC1–AC5**. While the exact specifications (e.g., power, optics, or haptic design) are not detailed in the provided data, these models likely cater to different patient needs, such as varying dioptric powers or lens configurations. The choice of model depends on the surgeon’s assessment and the patient’s specific ocular anatomy.

• How should the Model AC Intraocular Lens (AC1–AC5) be stored before use?

  The Model AC Intraocular Lens (AC1–AC5) must be stored in its original, sterile packaging until ready for use. Since it is a single-use device, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and integrity until implantation by a trained ophthalmic surgeon.