3M Vision Care Posterior Chamber IOL Perspex CQ-UV
PMA P830040
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830040 | Date31 Dec 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- Withdrawn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
- Trade Name
- Styles 30 & 31 Posterior Chamber IOLs
- Generic Name
- intraocular lens
- PMA Number
- FDA Product Code
- HQL
- Device Class
- Class III
- Regulation
- 21 CFR Part 886.3600
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S002
Overview
AI-generated summary, 18 Sep 2026
The 3M Vision Care Posterior Chamber IOL Perspex CQ-UV is an intraocular lens designed for implantation in the posterior chamber of the eye. It is intended to restore vision following cataract surgery or other conditions requiring lens replacement, providing optical correction by replacing the natural crystalline lens.
This device is supplied as a single-use, non-sterile implant that requires sterilisation prior to use. It is classified as a Class III medical device under FDA regulations and has received FDA Premarket Approval (PMA). The lens is manufactured from Perspex material with CQ-UV treatment, and its use is governed by ophthalmic surgical protocols, adhering to strict regulatory standards for intraocular implants.
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Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the 3M Vision Care Posterior Chamber IOL Perspex CQ-UV, and how does it differ from a natural lens?
The 3M Vision Care Posterior Chamber IOL Perspex CQ-UV is designed to replace the natural crystalline lens in the eye after cataract surgery or other conditions requiring lens removal. Unlike the natural lens, which focuses light onto the retina for clear vision, this intraocular lens (IOL) provides a permanent optical correction by being implanted in the posterior chamber of the eye, restoring vision where the natural lens was lost or damaged.
Is this device single-use or reusable, and what preparation is required before use?
This device is supplied as a single-use, non-sterile implant. Since it is not sterile out of the package, it must be sterilized prior to implantation following standard ophthalmic surgical protocols. Sterilization is a critical step to ensure safety and compliance with medical device regulations before use.
What material is the lens made from, and what does the CQ-UV treatment signify?
The lens is manufactured from Perspex material, which is a type of acrylic polymer. The CQ-UV treatment indicates that the lens has undergone a specific process to enhance its resistance to ultraviolet light, which may help reduce potential long-term complications related to UV exposure in the eye.
How was this device approved by the FDA, and what does the PMA number indicate?
This device received FDA Premarket Approval (PMA) through the formal PMA process, which is required for Class III medical devices like intraocular lenses. The PMA number **P830040** is a unique identifier assigned by the FDA to track and verify the approval status of this specific device, ensuring it meets rigorous safety and effectiveness standards for use in the United States.
What should clinicians consider regarding storage and handling of this device before surgery?
Since the device is non-sterile and single-use, clinicians must follow strict sterilization protocols before handling or implanting it. Storage should be done in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until sterilization. Always refer to the manufacturer’s instructions for specific sterilization methods and storage guidelines to ensure safety and functionality.