Recall Z-1007-2022— Carl Zeiss Meditec AG
Class II · Ongoing
Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2022-03-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Carl Zeiss Meditec AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-16
- Firm location
- Oberkochen, Germany
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.