510(k) Report

FDA product code · Ophthalmic

Ring, Endocapsular

MRJClass IIIPMA required2 decisions since 20030 recalls

2 FDA decisions since 2003. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of MRJ 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 · MRJ

1in 2025

2009: 12011: 12012: 12013: 12015: 12016: 12017: 12019: 22022: 12023: 32024: 42025: 1
2007high 4 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRJ

Too few MRJ 510(k)s in any year since 2007 to give a median.

Recalls per year · MRJ

No recall names MRJ since 2007.

Adverse event reports per year · MRJ

3in 2025

2007: 12009: 32013: 12014: 12016: 22017: 12018: 12022: 22023: 92024: 122025: 3
2007high 12 (2024) · low 0 (2008)2025

MAUDE reports naming product code MRJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20091—03
20100—00
20111—00
20121—00
20131—01
20140—01
20151—00
20161—02
20171—01
20180—01
20192—00
20200—00
20210—00
20221—02
20233—09
20244—012
20251—03
20260—0—
FIG. 1 — MRJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MRJ? 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