The FDA has posted 6 enforcement recalls from Orascoptic Surgical Acuity since 2025, none of them Class I (most serious). Most recent report: Sep 3, 2025.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Firm name as filed with the FDA: “Orascoptic Surgical Acuity”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.