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HomeOculo-Plastik Inc › Cox® II, SS Ocular Laser Shield, small (non glare) w. suction cup

Cox® II, SS Ocular Laser Shield, small (non glare) w. suction cup

Oculo-Plastik Inc · Model 21-262E · UDI-DI 10697660001545

HOY
10
510(k) clearances
49
Adverse events
1
Recalls
719
Facilities

Description

Cox® II ocular laser shields are intended to protect the eyes during IPL and laser procedures close to the eyes and on the face. They are inserted under the eyelids, on the ocular globes for the length of the procedure. They should not be left in place more than 60 minutes. The posterior polished surface and well-polished edges are intended to avoid corneal abrasions. The anterior surface is non-reflective treated to avoid reflection of the laser beam or IPL light source. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT OR RADIO FREQUENCY. After every case application and before sterilization, always verify visually and manually the condition of both surfaces and edges of the device. For the comfort and safety of the patient during insertion of the ocular shields an ophthalmic topical anaesthetic and ointment (non petroleum based for laser) is recommended. Users must choose a shield size appropriate to the globe. During periorbital surgery the shields should cover the entire globe.

Recalls

DateFirmReason
2008-06-05Phillips Safety ProductsRadiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.