Silikon 1000

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

Generic Name

Fluid, intraocular

PMA Number

P950008 ↗

FDA Product Code

LWL

Device Class

Class III

Regulation

21 CFR Part 886.4275

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

• Alcon Vision System

  Class II

  FDA 510(k) K063583 Active Cleared 9 May 2008

• Opti-Free Express Multi-Purpose Solution

  Class II

  FDA 510(k) K981574 Active Cleared 6 Jul 1998

• Inteliport Occluding Device

  Unclassified

  FDA 510(k) K040231 Active Cleared 13 Jul 2004

• Soft (Hydrophilic) Contact Lens Care Solution

  Class II

  FDA 510(k) K031193 Active Cleared 3 Jul 2003

• Alcon Multi-Purpose Solution

  Class II

  FDA 510(k) K071236 Active Cleared 12 Dec 2007

• Models 1S & 1P Intraocular Lens

  Class III

  FDA PMA P800049 Active Approved 31 Mar 1983

See all devices from Alcon →

• What clinical scenarios is Silikon 1000 specifically approved for when used as a retinal tamponade?

  Silikon 1000 is FDA-authorized for prolonged retinal tamponade in complicated retinal detachments where conventional treatments are insufficient. This includes cases of proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis (including primary use in AIDS-related CMV retinitis), giant retinal tears, and post-perforating injuries. It is also indicated for retinal detachments caused by viral retinal infections where other interventions are not suitable.

• How is Silikon 1000 supplied, and what precautions should be taken during handling?

  Silikon 1000 is supplied as a sterile, single-use 8.5 mL vial. Since it is intended for vitreoretinal surgical procedures, it must be handled under sterile conditions to maintain its non-pyrogenic and clear properties. The viscosity is 1000 centistokes, so care should be taken to avoid contamination or exposure to non-sterile environments during preparation and administration.

• Is Silikon 1000 reusable, and if not, what are the implications for storage?

  No, Silikon 1000 is explicitly designed for single-use only. This means each vial is intended for one surgical procedure and must not be reused. Proper storage under ophthalmic surgical protocols is critical to preserve sterility and efficacy, as reuse could compromise patient safety and device integrity.

• What regulatory pathway does Silikon 1000 follow, and what does this mean for clinicians?

  Silikon 1000 follows the FDA’s **Premarket Approval (PMA)** pathway, classified as a **Class III** intraocular fluid. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use as a prolonged retinal tamponade in complex cases. Clinicians should confirm compliance with the approved indications and surgical protocols outlined in the PMA authorization (PMA #P950008) to ensure proper use.