FDA product code · Ophthalmic

Ophthalmic Sealant

Name: FDA decisions, review times, recalls and adverse event reports for product code PFZ
Creator: 510(k) Report

PFZClass IIIPMA required1 decision since 20140 recalls

1 FDA decision since 2014. No recall names this code.

An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye.

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 PFZ 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 · PFZ

1in 2021

2007high 4 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PFZ

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

Recalls per year · PFZ

No recall names PFZ since 2007.

Adverse event reports per year · PFZ

2in 2018

2007high 2 (2018) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	4	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	2
2019	1	—	0
2020	3	—	0
2021	1	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

FIG. 1 — PFZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PFZ? 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

Ophthalmic Sealant

What has FDA decided in PFZ lately?