510(k) Report

FDA product code · Ophthalmic

Lens, Intraocular, Toric Optics

MJPClass III21 CFR 886.3600PMA required0 decisions since 19983 recalls

0 FDA decisions since 1998. 3 recalls name this code, 0 of them Class I.

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 MJP 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 · MJP

1in 2020

2013: 22014: 52015: 52016: 42017: 12018: 12020: 12026 (partial year): 1
2007high 5 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJP

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

Recalls per year · MJP

1in 2023

2020: 12021: 12023: 1
2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MJP

1,499in 2025

2008: 872009: 2592010: 1622011: 12012: 62013: 72014: 862015: 3892016: 2852017: 3112018: 3642019: 3822020: 2112021: 2852022: 5132023: 7482024: 9852025: 1,499
2007high 1,499 (2025) · low 0 (2007)2025

MAUDE reports naming product code MJP, 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—00
20080—087
20090—0259
20100—0162
20110—01
20120—06
20132—07
20145—086
20155—0389
20164—0285
20171—0311
20181—0364
20190—0382
20201—1211
20210—1285
20220—0513
20230—1748
20240—0985
20250—01,499
20261—0—
FIG. 1 — MJP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MJP? 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

Related product codes

Other codes under 21 CFR 886.3600.