Soft Lens Thermal Disinfecting Unit

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

Full name

The Soft Lens Thermal Disinfecting Unit

Generic Name

Sterilizer, soft-lens, thermal, ac-powered

PMA Number

P820082 ↗

FDA Product Code

HRD

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002 (THIRTY DAY TRACK)

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See all devices from Abbott Medical Optics, Inc. →

• What is the primary purpose of this device, and how does it differ from other contact lens disinfection methods?

  This device, The Soft Lens Thermal Disinfecting Unit, is specifically designed for thermal disinfection of soft contact lenses using heat treatment. Unlike chemical disinfectants or UV-based systems, it eliminates microorganisms through controlled heat while preserving lens integrity, allowing safe reuse of single-use lenses in clinical or home settings. It operates via AC power and is classified as a class II medical device under FDA regulations.

• Is this device intended for single-use or reusable lenses, and how does that affect its use?

  The device is not for single-use lenses—it is explicitly designed for thermal disinfection of soft contact lenses, enabling their safe reuse after processing. Since it employs heat treatment, it is intended for reusable lenses (e.g., those labeled as single-use when not disinfected) in clinical or home environments. Always follow manufacturer guidelines to avoid damaging lenses or compromising sterility.

• What storage conditions are required for this device to maintain its effectiveness and prevent contamination?

  The device must be stored in a clean, dry environment to prevent contamination, as no additional sterility guarantees beyond thermal processing are specified. Avoid exposure to moisture, dust, or extreme temperatures, as these could compromise its functionality or introduce microbial risks. Regular cleaning of the unit per manufacturer instructions is also recommended.

• Does this device have any special considerations for use in clinical settings, such as compatibility with other equipment?

  The device is AC-powered and designed for clinical or home use, but no specific compatibility details (e.g., MRI safety or integration with other systems) are provided beyond its thermal disinfection function. Since it operates under FDA-authorized standards (PMA P820082), clinical users should confirm its electrical requirements match their facility’s power infrastructure. Always follow the manufacturer’s operational guidelines to ensure safe and effective use.