Orascoptic Surgical Acuity — Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
⚠️ Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 3, 2025
Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.
What's affected?
- Product
- Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
- Lot code
- All serial numbers manufactured between June 6, 2023 - May 14, 2025
Additional details
All serial numbers manufactured between June 6, 2023 - May 14, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10,611 units.
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