Cold Disinfection Regimen

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

Generic Name

Accessories, soft lens products

PMA Number

P790001 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

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See all devices from Advanced Medical Optics, Inc. →

• What is the primary purpose of the Cold Disinfection Regimen and how does it differ from traditional lens disinfection methods?

  The Cold Disinfection Regimen is designed specifically for reusable soft contact lenses to reduce microbial contamination without using heat. Unlike traditional methods that rely on heat to disinfect lenses, this regimen employs a cold process, making it suitable for ophthalmic settings where heat-sensitive materials or patient comfort may be a concern. It ensures compliance with hygiene standards for soft lenses while maintaining sterility.

• Is the Cold Disinfection Regimen sterile upon delivery, and how should it be handled to maintain its effectiveness?

  The Cold Disinfection Regimen is supplied as a non-sterile solution, meaning it is not sterile at the time of delivery. To preserve its efficacy, storage and handling must strictly follow the manufacturer’s instructions. Since it is intended for reusable use in ophthalmic settings, proper cleaning and maintenance of the solution container are critical to prevent contamination and ensure continued effectiveness.

• Are there different sizes or models of the Cold Disinfection Regimen, or is it a single-use or reusable solution?

  The Cold Disinfection Regimen is supplied as a reusable solution for ophthalmic use, not as single-use. The data does not specify variations in size or model, indicating it is likely a standardized regimen for general use in maintaining soft contact lens sterility. Reusability aligns with its intended purpose for clinical settings where multiple lenses are processed.

• What regulatory pathway does the Cold Disinfection Regimen follow, and what does this mean for its use in clinical settings?

  The Cold Disinfection Regimen is authorized under the FDA PMA (Premarket Approval) pathway, with PMA Number P790001. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use—maintaining the sterility of reusable soft contact lenses. Clinicians can rely on this approval when integrating the regimen into their ophthalmic hygiene protocols, though adherence to manufacturer instructions remains essential.

• Does the Cold Disinfection Regimen have any special storage requirements beyond standard room temperature, and is it safe for use with MRI equipment?

  The data does not specify unusual storage requirements beyond general manufacturer guidelines, which should be followed to preserve the solution’s efficacy. There is no mention of MRI safety in the provided details, so its compatibility with MRI environments cannot be confirmed. Clinicians should verify compatibility with their specific MRI systems or consult the manufacturer for guidance if MRI exposure is a concern.