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LASIK Caro-Avalos Flap Smoother
KATALYST SURGICAL LLC · Model 8080 · UDI-DI 00840096200089
HNQ
Prescription
10
510(k) clearances
109
Adverse events
4
Recalls
187
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2022-03-16 | Carl Zeiss Meditec AG | High friction of the slider can cause the device to stick, or not move as intended. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.