Skip to content

Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)

by Abbott Medical Optics, Inc.

510(k) K121721

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121721 Date15 Oct 2012ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1755-2024 FDA Class II initiated 14 Mar 2024

    Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a unit used in phacofragmentation procedures, specifically designed as laminar flow phaco tips and an irrigation sleeve. It is intended for use in ophthalmic surgery to facilitate the emulsification and aspiration of cataractous lens material while maintaining a stable anterior chamber through controlled fluid dynamics.

The device is supplied as a reusable instrument in a 21G size. It has received FDA 510(k) clearance (K121721) as substantially equivalent to a predicate device and is classified as a Class II medical device under regulation number 886.4670. It is non-sterile and intended for reprocessing between uses in accordance with manufacturer instructions.

Other devices from Abbott Medical Optics, Inc.

See all devices from Abbott Medical Optics, Inc. →

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Laminar Flow Phaco Tips and Irrigation Sleeve used for?

    This device is used in phacofragmentation procedures during ophthalmic surgery to emulsify and aspirate cataractous lens material while maintaining a stable anterior chamber through controlled fluid dynamics.

  • Is the Laminar Flow Phaco Tips and Irrigation Sleeve sterile when supplied?

    The device is supplied non-sterile and is intended for reprocessing between uses in accordance with the manufacturer's instructions for cleaning and sterilization.

  • What size and configuration is the Laminar Flow Phaco Tips and Irrigation Sleeve available in?

    The device is supplied as a reusable instrument in a 21G size, consisting of laminar flow phaco tips and an irrigation sleeve designed for use in cataract surgery.