Atlas FDA

HOC

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Clip, Iris Retractor
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2013: 10 · 2014: 31 · 2015: 20 · 2018: 11 · 2025: 77 · 2026: 91
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PART #860070 ULTRAPAK & #860075 ULTRAPAK (K871474)Medical Technical Products1987-08-10
PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION (K830871)Phakosystems, Inc.1983-06-02

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