Modified J&C Loop Post. Chamber Intraocular Lens
by Medical Development Research, Inc.
PMA P900037
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900037 | 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- Withdrawn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
- 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 Modified J&C Loop Post-Chamber Intraocular Lens is a type of intraocular lens designed for implantation within the eye to restore vision following cataract surgery or corneal opacity removal. It is a foldable, posterior chamber lens that positions itself behind the iris and natural lens, providing optical correction by replacing the eye’s original lens.
This device is intended for single-use in ophthalmic surgical settings and requires sterile packaging. It is classified as a Class III medical device under FDA regulations (886.3600) and has received FDA Premarket Approval (PMA P900037). The lens is supplied in a sterile, pre-packaged format and must be handled under aseptic conditions to ensure patient safety.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Modified J&C Loop Post-Chamber Intraocular Lens and how does it differ from standard intraocular lenses?
The Modified J&C Loop Post-Chamber Intraocular Lens is designed specifically for implantation in the posterior chamber of the eye to replace the natural lens after cataract surgery or corneal opacity removal. Unlike standard intraocular lenses, this foldable lens is positioned behind the iris and the eye’s natural lens, providing optical correction by restoring vision. Its foldable design allows for easier implantation through smaller incisions, which can reduce surgical trauma and aid in recovery.
Is this device intended for reuse or single-use, and what are the handling requirements?
This device is explicitly intended for single-use only in ophthalmic surgical settings. It comes in sterile, pre-packaged format, meaning it must be handled under aseptic conditions to maintain sterility and ensure patient safety. Reuse is not recommended or supported by the manufacturer.
How is the Modified J&C Loop Post-Chamber Intraocular Lens regulated, and what does that mean for purchasing or using it?
The device is classified as a Class III medical device under FDA regulations (886.3600) and has received FDA Premarket Approval (PMA P900037). This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use. Purchasers or clinicians should confirm the device’s compliance with FDA requirements and ensure it is sourced directly from authorized distributors or the manufacturer to guarantee authenticity and regulatory adherence.
Are there different sizes or models available for this intraocular lens, and if so, how would a clinician determine the appropriate one for a patient?
The provided data does not specify individual sizes or models of the Modified J&C Loop Post-Chamber Intraocular Lens. Typically, intraocular lenses come in various optical powers and haptic designs to accommodate different eye anatomies and prescriptions. Clinicians would rely on preoperative measurements (such as axial length, keratometry, and IOL power calculations) to select the appropriate lens for a patient’s specific needs. It is recommended to consult the manufacturer’s documentation or a surgical planning tool for precise sizing guidance.