Home › Oculo-Plastik Inc › Autoclavable Plastic Ocular Shield, bilateral, large, t-yellow
Autoclavable Plastic Ocular Shield, bilateral, large, t-yellow
Oculo-Plastik Inc · Model 23-206YE · UDI-DI 10697660003198
10
510(k) clearances
49
Adverse events
1
Recalls
719
Facilities
Description
The plastic ocular shields are used to protect the eyes when working with a scalpel, electro-cutter or other energy sources requiring protective plastic shields as the metal would be conductive (ex: RF system). The ocular shields are inserted under the eyelids over the globe, and remain in place for the duration of the intervention. They should not be left in place more than 60 minutes. PLASTIC OCULAR SHIELDS ARE NOT INTENDED FOR USE WITH LASER OR IPL SYSTEMS.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-06-05 | Phillips Safety Products | Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling. |
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Get your free API keyRead the docsData 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.