510(k) · Cleared
Recalled · Class II · 2025Alcon Surgical Procedure Packs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · LRO General Surgery Tray
Cleared on Apr 29, 1988 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 14 times.
- Decided
- Apr 29, 1988
- Review
- 52 days
- Class
- Class II
- Product code
- LRO
- Recalls
- 14
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK880961 Alcon Surgical Procedure PacksAlcon Laboratories · 1988
- Descendant · cites it directly · 0 of its ownK971465 National Medical Halthcare Custom Ophthalmic Kits or TraysNational Healthcare Mfg. Corp. · 1997
Most influential descendants
Showing 1 of 1 · See all- K971465National Medical Halthcare Custom Ophthalmic Kits or TraysNational Healthcare Mfg. Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880961 | Alcon Surgical Procedure Packs | Alcon Laboratories | 1988 | — |
| +1 | K971465 | National Medical Halthcare Custom Ophthalmic Kits or Trays | National Healthcare Mfg. Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRO device
- #1 K212258 Medline Cardiovascular Procedure Kitscore 2.4 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971465 | National Medical Halthcare Custom Ophthalmic Kits or Trays | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2025 | Class II | Z-1293-2025 | Software design | 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… |
| Mar 15, 2024 | Class II | Z-1606-2024 | Under Investigation by firm | Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. |
| Feb 21, 2024 | Class II | Z-1370-2024 | Nonconforming Material/Component | 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… |
| Sep 7, 2023 | Class II | Z-0260-2024 | Nonconforming Material/Component | Custom surgical procedure packs contain latex gloves but are labeled as "latex free". |
| Mar 10, 2023 | Class II | Z-1291-2023 | Employee error | Sterility; Steril surgical procedure packs contain incomplete seals. |
| Oct 31, 2022 | Class II | Z-0354-2023 | Nonconforming Material/Component | 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… |
| Jun 9, 2022 | Class II | Z-1373-2022 | Process control | 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 | Nonconforming Material/Component | Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages. |
| Aug 24, 2020 | Class II | Z-0095-2021 | Nonconforming Material/Component | 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… |
| Aug 8, 2017 | Class II | Z-0053-2018 | Nonconforming Material/Component | 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. |
| Sep 21, 2015 | Class II | Z-0195-2016 | Mixed-up of materials/components | 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 | Nonconforming Material/Component | 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… |
| May 16, 2014 | Class II | Z-1947-2014 | Employee error | 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 | Process control | 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. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971465 (National Healthcare Mfg. Corp., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LRO
Too few LRO 510(k)s in any year since 2007 to give a median.
Recalls per year · LRO
14in 2025
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
MAUDE reports naming product code LRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 1 | 23 |
| 2011 | 0 | — | 11 | 17 |
| 2012 | 0 | — | 4 | 64 |
| 2013 | 0 | — | 11 (11) | 25 |
| 2014 | 0 | — | 59 (58) | 59 |
| 2015 | 0 | — | 5 | 628 |
| 2016 | 0 | — | 4 | 805 |
| 2017 | 0 | — | 29 | 523 |
| 2018 | 0 | — | 31 | 384 |
| 2019 | 0 | — | 4 | 406 |
| 2020 | 0 | — | 3 | 767 |
| 2021 | 1 | — | 3 | 920 |
| 2022 | 1 | — | 192 | 1,134 |
| 2023 | 0 | — | 18 (2) | 1,913 |
| 2024 | 0 | — | 60 (1) | 3,031 |
| 2025 | 0 | — | 14 (5) | 5,488 |
| 2026 | 0 | — | 75 (16) | — |
https://510kreport.com/device/K880961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880961: Alcon Surgical Procedure Packs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880961
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026