Carl Zeiss VisuMax Laser Keratome Treatment Packs Recalled for Size Mismatch
Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a size mismatch in surgical components, which is a significant quality control issue but does not involve reported injuries or high-risk pathogens.
Plain-English summary
Carl Zeiss Meditec AG is recalling specific treatment packs used on the VisuMax Laser Keratome. The affected products are Size M treatment packs, Part Number 1462-333, from Lot M130010. These packs are indicated for the creation of corneal flaps in patients undergoing LASIK surgery or other treatments requiring lamellar resection of the cornea.
The recall was initiated because the Size M treatment packs may actually contain Size S components. This discrepancy could result in the use of incorrectly sized equipment during surgical procedures. The affected products were distributed only in Nevada.
Healthcare providers and consumers should stop using the affected treatment packs immediately. Users should contact Carl Zeiss Meditec AG for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring…
- Manufacturer
- Carl Zeiss Meditec AG
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- P/N 1462-333
- Size M
- Lot # M130010
Distribution
Distributed in 1 state:
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