SOF-FORM Allvue Multifocal (Polymacon) Contact Lens
by Salvatori Ophthalmics Mfg. Corp.
PMA P840006
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840006 | Date17 May 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Sof-Form Allvue Multifocal (Polymacon) Contact Len
- Trade Name
- Synsoft(Tm) (Polymacon) Bifocal Contact Lens
- Generic Name
- Lenses, soft contact, daily wear
- PMA Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
This device is a Lens, Soft Contact, Daily Wear, designed as a multifocal contact lens intended to correct presbyopia. The SOF-FORM Allvue Multifocal (Polymacon) Contact Lens is constructed from polymacon, a silicone hydrogel material, and is engineered to provide clear vision at multiple focal distances for daily wear use.
The lens is supplied as a single-use or disposable product, intended for ocular use under professional fitting and supervision. It is regulated under FDA Premarket Approval (PMA) with the designation P840006 and falls under the product code LPL. No MRI safety or reusable specifications are noted in the data. Storage and handling must comply with standard ophthalmic contact lens protocols to ensure sterility and safety.
Other devices from Salvatori Ophthalmics Mfg. Corp.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the SOF-FORM Allvue Multifocal (Polymacon) Contact Lens, and how does it differ from single-vision lenses?
The SOF-FORM Allvue Multifocal (Polymacon) Contact Lens is designed specifically to correct presbyopia, allowing users to see clearly at multiple focal distances—near, intermediate, and far—without switching lenses. Unlike single-vision lenses, which correct vision at one distance, this multifocal lens integrates multiple optical zones to provide continuous vision across these ranges, making it ideal for patients experiencing age-related near-vision difficulties.
Is this lens intended for daily wear, or can it be worn for extended periods?
The SOF-FORM Allvue Multifocal (Polymacon) Contact Lens is explicitly labeled for daily wear, meaning it is intended to be worn during waking hours and removed before sleep. While it is not explicitly classified as an extended-wear lens, standard ophthalmic contact lens protocols should be followed to ensure safety and comfort during use.
How is the lens supplied, and is it single-use or reusable?
The SOF-FORM Allvue Multifocal (Polymacon) Contact Lens is supplied as a single-use or disposable product, meaning each lens is intended for one-time use only. This design minimizes the risk of infection and maintains sterility, as reuse is not recommended or supported by the manufacturer’s specifications.
What material is the lens made from, and how does that affect its performance?
The lens is constructed from polymacon, a silicone hydrogel material. This material is designed to provide high oxygen permeability, which enhances comfort and reduces the risk of complications associated with low oxygen transmission. The silicone hydrogel also contributes to better moisture retention on the lens surface, improving wearer satisfaction for daily use.
What regulatory pathway does this device follow, and how does that impact its availability?
This device follows the FDA Premarket Approval (PMA) pathway, with the approval number P840006 and product code LPL. This means it has undergone rigorous clinical evaluation to ensure safety and effectiveness for its intended use. Availability is governed by FDA compliance, and it is distributed under the trade name SYNSOFT™ (Polymacon) Bifocal Contact Lens by Salvatori Ophthalmics Mfg. Corp.