PreVue Pre-loaded System, IPURE Pre-loaded System
PMA P080004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP080004 | Date26 Sep 2008 | 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- Withdrawn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
- Trade Name
- Hoya Ispheric Model Ya-60BB Intraocular Lens
- 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 Hoya Ispheric Model YA-60BB Intraocular Lens is a foldable, single-piece intraocular lens designed for primary implantation in the capsular bag of the eye. It is intended for visual correction of aphakia in adult patients following cataractous lens removal, restoring clear vision by replacing the natural lens.
This device is supplied as a pre-loaded system, intended for single-use in sterile surgical settings. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA). The lens is non-magnetic and compatible with MRI environments, with no specific storage requirements beyond standard sterile packaging conditions. Authorisation is granted under PMA number P080004.
Other devices from Hoya Surgical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary use of the PreVue Pre-loaded System and how does it differ from standard intraocular lenses?
The PreVue Pre-loaded System, specifically the Hoya Ispheric Model YA-60BB Intraocular Lens, is designed for **primary implantation in the capsular bag** of the eye to correct aphakia—meaning it replaces the natural lens removed during cataract surgery. Unlike some lenses that may require additional suturing or placement outside the capsular bag, this foldable, single-piece lens is intended to be implanted directly into the capsular bag, restoring clear vision for adult patients. Its pre-loaded design simplifies handling in sterile surgical settings.
Is this device reusable, or is it intended for single-use only?
The PreVue Pre-loaded System is explicitly intended for **single-use in sterile surgical settings**. This aligns with standard practices for intraocular lenses to ensure patient safety and sterility, as the device is packaged and sterilized for one-time implantation.
What storage conditions are required for the PreVue Pre-loaded System?
The device does not have specific storage requirements beyond maintaining **standard sterile packaging conditions**. Since it is pre-loaded and sterile, it should be stored in its original packaging until use, following general sterile supply chain protocols for surgical instruments.
Can this intraocular lens be used in patients who require MRI scans after implantation?
Yes, the Hoya Ispheric Model YA-60BB Intraocular Lens is **non-magnetic**, making it compatible with MRI environments. This ensures patients can safely undergo MRI scans post-implantation without interference from the lens.
What regulatory pathway was followed for approval of this device, and how does that affect its use?
The device was approved through the **FDA Premarket Approval (PMA) process**, which is required for Class III medical devices like intraocular lenses. This rigorous pathway ensures the device meets strict safety and effectiveness standards before clinical use. Clinicians and buyers can rely on this approval for confidence in its performance and compliance with U.S. regulatory requirements.