Model UV44B Intraocular Lens
by Abbott Medical Optics, Inc.
PMA P880041
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880041 | Date8 May 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- Withdrawn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
- Lens, contact (other material) - daily
- PMA Number
- FDA Product Code
- HQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5916
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Model UV44B Intraocular Lens is a contact lens designed for intraocular implantation, classified as a Class II medical device under FDA regulations. It is intended for use in cataract surgery to replace the natural lens of the eye, restoring vision by focusing light onto the retina. Constructed from a specialized material, this lens is intended for single-use and is engineered to provide clear, stable vision post-implantation.
This intraocular lens is supplied sterile and intended for surgical use in a clinical setting by trained ophthalmologists. It is regulated under FDA Premarket Approval (PMA) with the designation P880041 and falls under the product code HQD. The device is non-reusable and must be handled under sterile conditions prior to implantation. No specific MRI safety information is provided, and storage should adhere to manufacturer guidelines to maintain sterility and functionality.
Other devices from Abbott Medical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary use of the Model UV44B Intraocular Lens in cataract surgery?
The Model UV44B Intraocular Lens is specifically designed to replace the natural lens of the eye during cataract surgery. Its purpose is to restore clear vision by focusing light onto the retina, providing stable and reliable vision for patients after implantation. It is intended for use by trained ophthalmologists in a clinical setting.
Is the Model UV44B Intraocular Lens reusable, or is it meant for single-use only?
The Model UV44B Intraocular Lens is explicitly intended for single-use only. This design ensures sterility and safety for each patient, as reuse is not permitted and could compromise the device’s integrity or risk infection.
How should the Model UV44B Intraocular Lens be stored to maintain its sterility and functionality?
The Model UV44B Intraocular Lens must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for surgical use, proper storage conditions—such as avoiding contamination, moisture, or extreme temperatures—are critical to ensure it remains safe for implantation.
What regulatory pathway does the Model UV44B Intraocular Lens follow, and what does that mean for clinicians?
The Model UV44B Intraocular Lens follows the FDA Premarket Approval (PMA) pathway, with the approval number P880041. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use in cataract surgery. Clinicians can rely on this approval as evidence of the lens’s regulatory compliance before use.
Are there any specific considerations for handling the Model UV44B Intraocular Lens before implantation?
Yes, the Model UV44B Intraocular Lens must be handled under sterile conditions prior to implantation, as it is supplied sterile and designed for single-use. Any breach of sterility—such as improper packaging handling or contamination—could invalidate its suitability for surgical use, so adherence to sterile techniques is mandatory.