Atlas FDA

LWL

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Fluid, Intraocular
Device class
Class III (high risk)
Regulation
21 CFR 886.4275
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2012: 6 · 2016: 13 · 2022: 13 · 2023: 18 · 2025: 27 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OMS SILICONE OIL INJECTOR (K844895)Optical Micro Systems, Inc.1985-06-24

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