FDA Device Intelligence
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Unit, Cryophthalmic

FDA product code HPS · Class 2 · Ophthalmic

2
Registered devices
8
Adverse events
4
Recalls
11
510(k) clearances

Devices with this code

MIRA Cryosurgical Probe, Lashkari Trichiasis — MIRA, INC.VitreQ — Vitreq B.V.

Recent recalls

DateFirmReason
2023-03-17Beaver Visitec International, Inc.Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenl
2010-04-08Mira, Inc.Devices distributed without an approved 510(k)
2010-04-08Mira, Inc.Devices distributed without an approved 510(k)
2010-04-08Mira, Inc.Devices distributed without an approved 510(k)

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.