Saturn II (Synergicon A) Contact Lens

• • Terminated Z-1976-2011 FDA Unclassified (pre-2012) ·initiated 1 Feb 2011 ·on shared PMA P840004

  Out of specification values were obtained for sterility testing. The pH of the saline solution may be higher than the spec (up to pH 8.6 compared to a spec limit of pH 7.8). The osmolarity of the saline solution may be lower than specification (263 mOsm/kg compared to a spec limit of 270)

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Saturn II(Tm) (Synergicon a) Contact Lens

Trade Name

B&L (Synergicon a) Synercon(Tm) Contact Lens

Generic Name

Lens, contact (polymethylmethacrylate)

PMA Number

P840004 ↗

FDA Product Code

HPX

Device Class

U

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

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See all devices from Wesley Jessen Corp. →

• What types of vision correction does the Saturn II™ (Synergicon A) Contact Lens address and how does its design support this purpose?

  The Saturn II™ (Synergicon A) Contact Lens is designed for optical correction of vision impairment by resting directly on the cornea. Its hybrid design balances comfort and clarity, making it suitable for extended wear. The lens is crafted from polymethylmethacrylate (PMMA), a durable material commonly used in contact lenses for stable vision correction.

• Is the Saturn II™ (Synergicon A) Contact Lens intended for single-use or reusable applications, and how is it packaged to ensure safety?

  The Saturn II™ (Synergicon A) Contact Lens is supplied in sterile, single-use vials, ensuring each lens is uncontaminated for direct application to the eye. This packaging design eliminates the risk of cross-contamination between uses, which is critical for maintaining ocular health and sterility.

• What should clinicians consider regarding storage and handling to maintain the lens’s integrity and sterility?

  To preserve sterility and functionality, clinicians must follow the manufacturer’s storage guidelines for the Saturn II™ (Synergicon A) Contact Lens. Since it is supplied in sterile, single-use vials, proper sealing and storage conditions—such as avoiding moisture, extreme temperatures, or contamination—are essential to prevent degradation before use.

• How do I identify the correct size of the Saturn II™ (Synergicon A) Contact Lens for a patient, and what reference codes are available?

  The Saturn II™ (Synergicon A) Contact Lens sizes are determined by the manufacturer’s reference codes, such as 3002807465, 3002340631, or others listed in the OpenFDA database. Clinicians should consult the manufacturer’s sizing charts or guidelines to match the correct reference code to the patient’s corneal measurements for optimal fit and vision correction.

• Can the Saturn II™ (Synergicon A) Contact Lens be used in environments with MRI machines, and what precautions should be taken?

  The Saturn II™ (Synergicon A) Contact Lens is not inherently MRI-safe unless explicitly stated on its packaging. If MRI is required, clinicians must verify compatibility with the manufacturer or use alternative imaging methods to avoid potential risks to the lens or patient. Always check the packaging for MRI safety warnings before use.