NDS Lens Maintenance System

• • Terminated Z-1234-03 FDA Unclassified (pre-2012) ·initiated 13 Aug 2003

  Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.

Generic Name

Accessories, soft lens products

PMA Number

P900029 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

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• Is the NDS Lens Maintenance System intended for single-use or reusable applications, and how should it be maintained to ensure safety?

  The NDS Lens Maintenance System is designed as a reusable device for both clinical and home use. Since it is not sterile, proper cleaning and maintenance per the manufacturer’s instructions are required to prevent contamination. Regular disinfection and adherence to the system’s operational guidelines are essential to maintain lens hygiene and integrity.

• What types of soft contact lenses is this system compatible with, and does it include any specific storage instructions?

  The system is classified under accessories for soft lens products, meaning it is intended for use with soft contact lenses as specified by the manufacturer. While the exact lens compatibility isn’t detailed, the system includes labeling changes to clarify lens storage timeframes when used with the Quick Care System, ensuring proper hygiene and reuse as directed.

• How was the regulatory approval for this device obtained, and what does the FDA Premarket Approval (PMA) cover?

  The NDS Lens Maintenance System received FDA Premarket Approval (PMA P900029), which covers its intended use for cleaning, disinfecting, and storing soft contact lenses. The approval also includes a labeling supplement (S001) to refine instructions—specifically, clarifying lens storage timeframes—without altering the core device functionality or indications.

• Are there any special handling or storage requirements for the NDS Lens Maintenance System itself?

  While the system itself is not sterile, it must be cleaned and maintained according to the manufacturer’s guidelines to prevent contamination. No specific storage conditions (e.g., temperature, humidity) are mentioned in the provided data, but standard hygiene practices for reusable medical devices should be followed to ensure longevity and safe operation.