Model P-11 Modified J-Loop Posterior Chamber IOL

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

intraocular lens

PMA Number

P890068 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

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See all devices from Chiron Ophthalmics →

• What is the primary purpose of the Model P-11 Modified J-Loop Posterior Chamber IOL, and in what types of procedures is it typically used?

  The Model P-11 Modified J-Loop Posterior Chamber IOL is designed to replace the natural lens of the eye after cataract surgery or other conditions requiring lens removal. It is intended for implantation in the posterior chamber, where it restores clear vision by focusing light onto the retina. This device is specifically engineered for procedures where capsular support is required to ensure proper positioning within the eye.

• Is the Model P-11 Modified J-Loop Posterior Chamber IOL intended for single-use or can it be reused?

  The Model P-11 Modified J-Loop Posterior Chamber IOL is explicitly supplied as a single-use, sterile implant. This design ensures patient safety and reduces the risk of infection or contamination, which is critical in surgical settings like ophthalmology.

• What regulatory pathway was followed for the approval of this intraocular lens, and what classification does it hold?

  The Model P-11 Modified J-Loop Posterior Chamber IOL received **Premarket Approval (PMA)** under the designation **P890068** from the FDA. It is classified as a **Class III** medical device, which is the highest risk classification for medical devices, requiring rigorous pre-market approval due to its critical role in restoring vision.

• How should the Model P-11 Modified J-Loop Posterior Chamber IOL be stored before use?

  While the provided data does not specify storage conditions explicitly, as a sterile, single-use surgical implant, it should be stored in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Always follow the manufacturer’s (Chiron Ophthalmics) specific storage instructions included with the packaging to maintain sterility and integrity.