Softec HD Posterior Chamber Intraocular Lens

No FDA recalls found in the data synced 6 Oct 2026.

Full name

The Softec Hd IOL

Trade Name

Lenstec Softec Hd Posterior Chamber Intraocular Lens

Generic Name

intraocular lens

PMA Number

P090022 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

• Lenstec Intraocular Lens (IOL) Injection System for Tetraflex Intraocular Lenses

  Class I

  FDA 510(k) K050638 Active Cleared 31 May 2005

• Lenstec Intraocular Lens (IOL) Injection System

  Class I

  FDA 510(k) K060533 Active Cleared 14 Apr 2006

• Lenstec LC Injection system

  Class I

  FDA 510(k) K161776 Active Cleared 29 Nov 2016

• Fluid Isolation Device

  Class II

  FDA 510(k) K091915 Active Cleared 27 Oct 2009

• ClearView 3 IOL

  Class III

  FDA PMA P200020 Active Approved 22 Jul 2022

• Lenstec Lc Injection System

  Class I

  FDA 510(k) K063802 Active Cleared 7 May 2007

See all devices from Lenstec, Inc. →

• What is the Softec HD IOL intended for and who is it designed for?

  The Softec HD Posterior Chamber Intraocular Lens (PCIOL) is specifically designed for capsular bag placement and is intended to replace the human crystalline lens following phacoemulsification cataract removal. It is approved for use in adults over the age of 21, making it suitable for standard cataract surgery patients in that age group.

• Is the Softec HD IOL single-use or reusable, and how should it be handled?

  The Softec HD IOL is supplied as a single-use implant, meaning each unit is intended for one surgical procedure only. Due to its classification as a sterile medical device, it requires sterile handling throughout the surgical process to ensure patient safety.

• What regulatory pathway does the Softec HD IOL follow, and what does that mean for its use?

  The Softec HD IOL is regulated under the FDA’s Premarket Approval (PMA) pathway, which is the highest level of scrutiny for medical devices. This approval (PMA number P090022) confirms that the device meets rigorous standards for safety and effectiveness, ensuring it can be legally used in ophthalmic surgical settings for its intended purpose.

• Are there any specific storage requirements or considerations for the Softec HD IOL?

  While the provided data does not explicitly detail storage conditions, as a sterile single-use implant, the Softec HD IOL should be stored according to the manufacturer’s instructions to maintain its integrity and sterility. Typically, this involves keeping it in a clean, dry environment, protected from contamination until use.