Carl Zeiss Meditec AG recalls ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

Recall date

March 16, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1007-2022

FDA classification

Class II

Brand / firm

Carl Zeiss Meditec AG

Sold / distributed

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

Why it was recalled

High friction of the slider can cause the device to stick, or not move as intended.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.