Metrosoft II (Polymacon) Hydrophilic Contact Lenses
PMA P820026
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820026 | Date13 Apr 1988 | 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- Withdrawn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
- Metrosoft(Tm) II (Polymacon) Hydrophilic Contact
- 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
- S002
Overview
AI-generated summary, 18 Sep 2026
The Metrosoft II (Polymacon) Hydrophilic Contact Lenses are classified as soft contact lenses designed for daily wear. These lenses are intended to correct refractive errors and improve visual acuity by resting directly on the cornea, providing clear and comfortable vision for extended periods.
These lenses are supplied as single-use or reusable, depending on the specific prescription and patient needs, and are regulated under FDA Premarket Approval (PMA). They are classified as Class II medical devices under the regulation number 886.5925. The lenses are intended for ophthalmic use and must be handled and stored according to manufacturer guidelines to maintain sterility and performance.
Other devices from Metrosoft, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses designed for extended wear, or are they only approved for daily use?
The Metrosoft II (Polymacon) Hydrophilic Contact Lenses are explicitly classified as soft contact lenses for daily wear, meaning they are intended for continuous wear during waking hours only. The description does not mention extended or overnight wear, so they should not be used beyond the manufacturer’s recommended daily schedule.
How are these lenses supplied—are they pre-packaged individually, or do they come in multi-unit packaging?
The data does not specify packaging details, but since they are soft contact lenses for daily wear, they are most likely supplied as single-use or reusable lenses in individual blister packs or cases, depending on the prescription. Reusable lenses would require proper cleaning and storage solutions, while single-use lenses would be pre-packaged for one-time wear.
Are these lenses sterile upon opening, and if so, how should they be handled to maintain sterility?
The lenses are regulated as medical devices and must be handled according to manufacturer guidelines to maintain sterility. While the data does not explicitly state they are sterile upon opening, soft contact lenses of this type are typically sterile-packaged for single-use or reusable applications. Always follow Metrosoft’s instructions for opening, handling, and storage to prevent contamination.
What regulatory pathway was followed for approval, and what does this mean for clinicians or buyers?
The Metrosoft II (Polymacon) Hydrophilic Contact Lenses were approved through the FDA Premarket Approval (PMA) process, specifically under PMA number P820026. This means the device underwent rigorous clinical evaluation to ensure safety and effectiveness before approval. Clinicians and buyers can rely on this pathway as evidence of the device’s regulatory scrutiny, though they should still follow the manufacturer’s instructions for proper use.