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Alcon Surgical Procedure Packs

by Alcon Laboratories, Inc.

510(k) K880961

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 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 NumberK880961 Date29 Apr 1988ClearedStatusActive

Recalls

14 recalls · 7 ongoing · FDA

    • Ongoing Z-1293-2025 FDA Class II initiated 10 Feb 2025

    Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.

    • Ongoing Z-1606-2024 FDA Class II initiated 15 Mar 2024

    Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.

    • Ongoing Z-1370-2024 FDA Class II initiated 21 Feb 2024

    Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.

    • Ongoing Z-0260-2024 FDA Class II initiated 7 Sep 2023

    Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

    • Ongoing Z-1291-2023 FDA Class II initiated 10 Mar 2023

    Sterility; Steril surgical procedure packs contain incomplete seals.

    • Ongoing Z-0354-2023 FDA Class II initiated 31 Oct 2022

    Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.

    • Ongoing Z-1373-2022 FDA Class II initiated 9 Jun 2022

    Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.

    • Terminated Z-1328-2021 FDA Class II initiated 2 Feb 2021

    Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.

    • Terminated Z-0095-2021 FDA Class II initiated 24 Aug 2020

    The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.

    • Terminated Z-0053-2018 FDA Class II initiated 8 Aug 2017

    Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.

    • Terminated Z-0195-2016 FDA Class II initiated 21 Sep 2015

    The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.

    • Terminated Z-1702-2015 FDA Class II initiated 28 Apr 2015

    The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.

    • Terminated Z-1947-2014 FDA Class II initiated 16 May 2014

    Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle

    • Terminated Z-1644-2009 FDA Unclassified (pre-2012) initiated 29 Apr 2009 on shared 510(k) K880961

    Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
LRO
FDA applicant
Alcon Laboratories
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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