Device product
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Z-2441-2025
Product summary
- Event
- Event 97260
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,611 units
- Official record key
device-enforcement:Z-2441-2025
Official wording
Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Code information: All serial numbers manufactured between June 6, 2023 - May 14, 2025
Distribution pattern: 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.
Derived failure modes
-
Unknown
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.