Style 17 & 17A Posterior Chamber IOLs
PMA P830033
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830033 | Date25 Apr 1986 | 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- Withdrawn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
- 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
- S003
Overview
AI-generated summary, 18 Sep 2026
The Style 17 and 17A Posterior Chamber Intraocular Lenses are intraocular lenses designed for implantation in the posterior chamber of the eye to replace the natural lens following cataract extraction or other indications requiring lens replacement. These lenses are intended to restore visual function by focusing light onto the retina, correcting refractive errors post-surgery.
These lenses are supplied sterile and intended for single-use. They are classified as Class III medical devices under FDA regulations (886.3600) and have received FDA Premarket Approval (PMA P830033, Supplement S005). The lenses are manufactured by Advanced Vision Science and are available in specific model variants (Style 17 and Style 17A) for surgical use in ophthalmic procedures. No MRI safety information is specified in the data provided.
Other devices from Advanced Vision Science
Questions
AI-generated answers, 18 Sep 2026
Are the Style 17 and 17A Posterior Chamber IOLs reusable or intended for single-use only?
The Style 17 and 17A Posterior Chamber IOLs are explicitly labeled as sterile and intended for **single-use only**. This is a standard practice for intraocular lenses to ensure patient safety and prevent cross-contamination between procedures.
What are the key differences between the Style 17 and Style 17A models?
The data provided does not specify technical or design differences between the **Style 17** and **Style 17A** models. However, as they are distinct trade names under the same product category (HQL), they may vary in optical power, haptic design, or other surgical considerations. For precise differences, consult the manufacturer’s surgical technique guide or packaging.
How should these IOLs be stored before use, and what are the shelf-life considerations?
The Style 17 and 17A IOLs are supplied **sterile**, but the data does not detail specific storage conditions (e.g., temperature, humidity) or shelf-life. Typically, intraocular lenses require protection from moisture, contamination, and extreme temperatures. Check the manufacturer’s packaging or instructions for storage guidelines to ensure integrity before surgery.
What regulatory pathway was followed for FDA approval of these IOLs, and when was the decision made?
The Style 17 and 17A Posterior Chamber IOLs received **FDA Premarket Approval (PMA)** under PMA number **P830033**, with the most recent supplement (S005) approved. The original decision was made on **September 26, 1986**, following a review by the Ophthalmic Devices Advisory Committee (OP). This classification reflects their status as **Class III devices** under FDA regulations (886.3600).