FDA-Device2022-05-04Class II
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Carl Zeiss Meditec AG
Hazard
High friction of the slider can cause the device to stick, or not move as intended.
Sold states
U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided
Affected count
1225 devices
Manufactured in
Rudolf-Eber-Str. 11, Oberkochen, Germany
Products
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2022Don't want to check this manually?
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