Z CARTRIDGE IOL DELIVERY SYSTEM— 510(k) K123888

Name: FDA 510(k) clearance K123888
Creator: U.S. Food and Drug Administration
Published: 2013-04-15

Substantially Equivalent

Aaren Scientific, Inc.

FDA 510(k) clearance K123888 for Z CARTRIDGE IOL DELIVERY SYSTEM, Substantially Equivalent on 2013-04-15. Applicant: Aaren Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Aaren Scientific, Inc.
Product code: Code MSS
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2012-12-18
Decision date: 2013-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSS

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K261174 — RxSight® Insertion Device2026-06-10
K252540 — ACCUJECT Injector Set 2.1-1P (LP604590)2025-09-16
K242389 — EyeGility Inserter for Preloaded enVista IOLs2024-10-10
K231106 — Accuject Refra Injector AR29002023-09-19
K231838 — RxSight® Insertion Device (63002)2023-08-15

Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K123888

K-number listed on FDA's recall record

Z-0071-2018 — AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.Class II·Terminated·Aaren Scientific Inc.·20170901

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123888.

Data sourced from openFDA. This site is unofficial and independent of the FDA.