ZEISS miLOOP Lens Fragmentation Device Recalled for Slider Friction Issue
Carl Zeiss Meditec is recalling the ZEISS miLOOP Lens Fragmentation Device due to high friction in the slider mechanism that may cause it to stick or fail to move as intended during cataract surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a medical device used in critical surgical procedures (cataract surgery) where malfunction of the slider mechanism could result in patient harm. No injuries or hospitalizations have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, consistent with High severity criteria.
Plain-English summary
The ZEISS miLOOP Lens Fragmentation Device (Model 303071-9090-000), manufactured by Carl Zeiss Meditec AG, is being recalled due to a friction issue in the slider mechanism. The device is used during cataract surgery to fragment cataracts. High friction of the slider can cause the device to stick or fail to move as intended, potentially affecting surgical performance.
Approximately 1,225 devices were distributed across multiple U.S. states and Puerto Rico. The affected devices carry lot number FG21082410. Surgical centers and hospitals that have received these devices should verify their inventory and contact Carl Zeiss Meditec AG for replacement or return instructions. Do not use affected devices in surgical procedures until replacements are obtained.
The recalled product
- Product
- ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
- Manufacturer
- Carl Zeiss Meditec AG
- Affected units
- 1,225
Distribution
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