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Sign in to claim this brandAaren Scientific
US
Last updated May 23, 2026
What Aaren Scientific makes
Aaren Scientific manufactures posterior-chamber acrylic intraocular lenses (IOLs) designed for pseudophakic patients, replacing the natural lens after cataract surgery.
The company’s portfolio is regulated under FDA Class III devices, with products listed under the Premarket Approval (PMA) and Unique Device Identifier (UDI) programs. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Aaren Scientific manufacture?
Aaren Scientific specializes in posterior-chamber intraocular lenses (IOLs) made of acrylic. These devices are specifically designed for pseudophakic patients, meaning they replace the natural lens of the eye after cataract surgery to restore vision.
Where is Aaren Scientific based?
Aaren Scientific is based in the United States. The company’s headquarters and operations are located within the country, which influences its regulatory framework and compliance requirements.
Which regulatory registries or databases list Aaren Scientific’s devices?
Aaren Scientific’s devices are listed under the FDA’s Premarket Approval (PMA) program and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for Class III devices, which require rigorous pre-market approval due to their higher risk.
How are Aaren Scientific’s devices classified by regulatory authorities?
Aaren Scientific’s intraocular lenses fall under FDA Class III classification. This classification is assigned to devices that support or sustain human life, are of substantial importance in preventing impairment or dysfunction, or present a potential unreasonable risk of illness or injury. Class III devices require a Premarket Approval Application (PMA) to demonstrate safety and effectiveness before they can be marketed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (125)
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Aaren Scientific has one FDA recall record initiated on 2017-09-01, which is listed with a terminated status. The recall was due to an incorrect recommended storage temperature indicated on the product label.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 1, 2017 | Z-0071-2018 | — | terminated | The recommended storage temperature on the label is incorrect. |