FDA product code · Ophthalmic
Intraocular Pressure Lowering Implant
5 FDA decisions since 2001. 4 recalls name this code, 4 of them Class I.
An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OGO at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · OGO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OGO
Too few OGO 510(k)s in any year since 2007 to give a median.
Recalls per year · OGO
4in 2018
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · OGO
140in 2025
MAUDE reports naming product code OGO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | — | 0 | 0 |
| 2013 | 7 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 50 |
| 2015 | 3 | — | 0 | 57 |
| 2016 | 6 | — | 0 | 86 |
| 2017 | 5 | — | 0 | 298 |
| 2018 | 9 | — | 4 (4) | 511 |
| 2019 | 6 | — | 0 | 352 |
| 2020 | 6 | — | 0 | 197 |
| 2021 | 6 | — | 0 | 243 |
| 2022 | 5 | — | 0 | 239 |
| 2023 | 6 | — | 0 | 184 |
| 2024 | 4 | — | 0 | 163 |
| 2025 | 4 | — | 0 | 140 |
| 2026 | 4 | — | 0 | — |
Planning a device in OGO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report