Models 1S & 1P Intraocular Lens

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

Full name

Models 1S & 1P

Generic Name

intraocular lens

PMA Number

P800049 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003

• 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

• Zirconia Silicate Bead IOL Tumble Polishing

  Class III

  FDA PMA P820035 Withdrawn Approved 28 Feb 1986

See all devices from Alcon →

• What is the primary purpose of the Models 1S & 1P Intraocular Lens, and in which procedures is it typically used?

  The Models 1S & 1P Intraocular Lens is designed to replace the natural crystalline lens after cataract extraction or other lens removal procedures. Its purpose is to restore vision by focusing light onto the retina, correcting refractive errors, and improving visual acuity following implantation in the posterior chamber of the eye.

• Are the Models 1S & 1P lenses single-use or reusable, and how should they be handled during surgery?

  The Models 1S & 1P lenses are intended for single-use only in sterile ophthalmic surgical settings. They are supplied sterile and must be handled using sterile techniques in a controlled environment to maintain integrity and prevent contamination.

• What regulatory pathway was followed for the approval of these lenses, and what classification do they hold under FDA regulations?

  The Models 1S & 1P Intraocular Lenses were authorized via a Premarket Approval (PMA P800049, Supplement S003). They are classified as Class III devices under FDA regulations (886.3600), reflecting their high-risk nature and the need for rigorous pre-market evaluation.

• Can these lenses be used in patients who require MRI scans, and why?

  No, the Models 1S & 1P lenses are non-MRI-conditional, meaning they are not safe for use in MRI environments. This is explicitly stated in the device’s specifications, and patients with these lenses should avoid MRI procedures unless specifically cleared by a radiologist or manufacturer.

• What type of surgical setting is recommended for implantation of these lenses, and why?

  These lenses are designed for use in ophthalmic surgical settings that adhere to sterile protocols. The requirement for sterile handling and controlled environments ensures patient safety and device integrity, as contamination or improper technique could compromise outcomes.