Model 14760 UV Absorbing Posterior Chamber Lenses
by Eyetech, LLC
PMA P880082
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880082 | Date13 Jun 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- 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
Overview
AI-generated summary, 18 Sep 2026
The Model 14760 UV Absorbing Posterior Chamber Lenses are intraocular lenses designed for implantation within the eye’s posterior chamber to replace the natural lens following cataract surgery or other indications requiring lens replacement. These lenses are engineered to correct refractive errors by focusing light onto the retina, restoring visual clarity and function.
These lenses are supplied sterile and intended for single-use in ophthalmic surgical settings. They are classified as Class III devices under FDA regulations and have received Premarket Approval (PMA) under PMA number P880082. The lenses are available in a UV-absorbing formulation to mitigate potential long-term exposure to ultraviolet light, ensuring compatibility with standard ophthalmic procedures and storage under sterile conditions.
Other devices from Eyetech, LLC
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Model 14760 UV Absorbing Posterior Chamber Lenses, and how do they differ from standard intraocular lenses?
The Model 14760 lenses are designed specifically to replace the natural lens in the eye’s posterior chamber after cataract surgery or other lens replacement procedures. Unlike standard intraocular lenses, these lenses include a **UV-absorbing formulation** to reduce long-term exposure to ultraviolet light, which may help protect the retina over time. They correct refractive errors by focusing light properly onto the retina, restoring clear vision.
Are these lenses intended for reuse, or are they meant for single-use in surgery?
The Model 14760 lenses are **sterile and intended for single-use only** in ophthalmic surgical settings. This ensures patient safety and compliance with sterile procedure protocols, as reuse could compromise sterility and integrity.
How should these lenses be stored before use, and what precautions should be taken?
Since the lenses are **sterile**, they must be stored in their original packaging under sterile conditions until use. The UV-absorbing formulation also implies they should be shielded from direct sunlight or excessive light exposure during storage to maintain their protective properties. Always follow manufacturer guidelines for unpacking and handling to preserve sterility.
What regulatory pathway was followed for approval of these lenses, and what class do they fall under?
The Model 14760 lenses are classified as **Class III devices** under FDA regulations, requiring **Premarket Approval (PMA)**. They were approved via PMA number **P880082**, indicating a rigorous review process to ensure safety and effectiveness for implantation in the posterior chamber of the eye.