IOL INJECTOR SET— 510(k) K070669

Clearance details

Applicant

Medicel AG

Product code

Code KYB

Device class

Class 1

Regulation

21 CFR 886.4300

Advisory panel

Ophthalmic

Date received

2007-03-12

Decision date

2007-11-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hasbrouck Heights, NJ, US

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• K063155 — MONARCH III IOL DELIVERY SYSTEM2007-03-27
• K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-282007-03-07

• K252540 — ACCUJECT Injector Set 2.1-1P (LP604590)2025-09-16
• K231106 — Accuject Refra Injector AR29002023-09-19
• K101134 — VISIAN NANOPOINT 2.0 INJECTOR MODEL LP6044302010-08-09
• K092023 — NAVIJECT SUB2-1P, MODEL: LP6044302009-07-28
• K040837 — MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE2004-06-17

Injury

218

Malfunction

1,989

Other

1

Total

2,208

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 →

• Z-1984-2013 — Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.Class II·Terminated·Medicel Ag·20130805

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070669.