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PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments

AURORA SURGICAL, LLC · Model AS3-628 · UDI-DI 08175700110693

HLF
3
510(k) clearances
0
Adverse events
1
Recalls
26
Facilities

Description

Double Ended LASIK Flap Lifter and Spatula (Seibel Style)

Recalls

DateFirmReason
2010-05-19Haag-Streit USA IncDuring the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US di

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.