LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)— 510(k) K121721

Clearance details

Applicant

Abbott Medical Optics, Inc.

Product code

Code HQC

Device class

Class 2

Regulation

21 CFR 886.4670

Advisory panel

Ophthalmic

Date received

2012-06-12

Decision date

2012-10-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Ana, CA, US

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Injury

2,378

Malfunction

8,768

Total

11,146

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-1755-2024 — Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.Class II·Ongoing·Johnson & Johnson Surgical Vision, Inc.·20240314

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121721.