# K880961: Alcon Surgical Procedure Packs

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Apr 29, 1988 after 52 days
- Product code: LRO (General Surgery Tray)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971465: National Medical Halthcare Custom Ophthalmic Kits or Trays (1997), 0 descendants of its own

## Recalls of this device
- Feb 10, 2025 · Class II · Z-1293-2025: 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 produc
- Mar 15, 2024 · Class II · Z-1606-2024: Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
- Feb 21, 2024 · Class II · Z-1370-2024: 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 terminall
- Sep 7, 2023 · Class II · Z-0260-2024: Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
- Mar 10, 2023 · Class II · Z-1291-2023: Sterility; Steril surgical procedure packs contain incomplete seals.
- Oct 31, 2022 · Class II · Z-0354-2023: 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 incr
- Jun 9, 2022 · Class II · Z-1373-2022: Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
- Feb 2, 2021 · Class II · Z-1328-2021: Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
- Aug 24, 2020 · Class II · Z-0095-2021: 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. T
- Aug 8, 2017 · Class II · Z-0053-2018: 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 u
- Sep 21, 2015 · Class II · Z-0195-2016: The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
- Apr 28, 2015 · Class II · Z-1702-2015: 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 
- May 16, 2014 · Class II · Z-1947-2014: 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
- Apr 29, 2009 · Not classified · Z-1644-2009: 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.

Source page: https://510kreport.com/device/K880961
Methodology: https://510kreport.com/methodology