RecallRadar

FDA Device recall Z-1007-2022

ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000

On 2022-05-04 the FDA classified a Class II recall of ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000 by Carl Zeiss Meditec Ag, citing high friction of the slider can cause the device to stick, or not move as intended.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1007-2022
ClassificationClass II
Statusongoing
Initiated2022-03-16
Published2022-05-04
Last updated2026-09-13 11:56 UTC
CompanyCarl Zeiss Meditec Ag
DistributionAL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, WA, WV

Product

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

Reason

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

Identifiers

code_infoModel: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1007-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.