Models A21-A & A21-B Posterior Chamber Intraocular Lens
by Vision Technologies Intl., Inc.
PMA P900053
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900053 | Date28 Feb 1991 | 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- Withdrawn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
- Full name
- Models A21-A & A21-B Posterior Chamber Intraocular
- 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 Models A21-A & A21-B are posterior chamber intraocular lenses, designed to replace the natural lens in cataract surgery or following lens removal. These devices are intended for implantation within the eye’s posterior chamber to restore vision by focusing light onto the retina, correcting refractive errors such as aphakia or presbyopia.
These lenses are supplied sterile and intended for single-use. They are classified as Class III medical devices under FDA regulations, with an approved Premarket Approval (PMA) under PMA number P900053. The models are supplied in sterile packaging and must be handled under aseptic conditions prior to implantation. No MRI safety information is specified, and sizes or additional specifications are not detailed in the provided data.
Questions
AI-generated answers, 18 Sep 2026
Are the Models A21-A & A21-B intraocular lenses reusable or intended for single-use only?
The Models A21-A & A21-B are explicitly designed for single-use only. They are supplied sterile in packaging that must be maintained under aseptic conditions prior to implantation, which reinforces their intended one-time use in cataract surgery or following lens removal.
What type of storage conditions should be maintained for these intraocular lenses before use?
While specific storage conditions aren’t detailed in the provided data, the lenses are supplied sterile and must be handled under aseptic conditions before implantation. This implies they should be stored in their original, unopened packaging in a clean, dry environment away from direct light or extreme temperatures until ready for use.
How were these lenses approved by the FDA, and what does that mean for their use?
The Models A21-A & A21-B received FDA approval through a Premarket Approval (PMA) process under PMA number P900053. This means the device underwent rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use—replacing the natural lens in cataract surgery or following lens removal—before being authorized for commercial distribution.
Are there any known size variations or model-specific differences between the A21-A and A21-B lenses?
The provided data does not specify any measurable differences in size, optical power, or physical specifications between the A21-A and A21-B models. The distinction between them is not detailed beyond their trade name, so additional information would be required to determine practical differences for clinical selection.