FDA recall Z-1007-2022

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-03-16

Report date

2022-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oberkochen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2022