510(k) · Cleared
ClearedAlcon Contact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · LRX Case, Contact Lens
Cleared on Jul 14, 1997 as substantially equivalent to K931620 (Alcon Laboratories, 1993) and 1 other predicate after a 73-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Jul 14, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915082 (1992). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK915082 Opti-Lens (TM) Contact Lens CaseRyder Intl. Corp. · 1992
- This deviceK971618 Alcon Contact Lens CaseAlcon Laboratories · 1997
- Descendant · cites it directly · 2 of its ownK974281 Alcon Contact Lens CaseAlcon Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK032309 Novelens Contact Lens Cleaning Enhancement and Storage AccessoryNovelens, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K974281Alcon Contact Lens CaseAlcon Laboratories · 1998 · cites it directly2descendants
- K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004 · cites it directly0descendants
- K032309Novelens Contact Lens Cleaning Enhancement and Storage AccessoryNovelens, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915082 | Opti-Lens (TM) Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| 0 (this device) | K971618 | Alcon Contact Lens Case | Alcon Laboratories | 1997 | — |
| +1 | K974281 | Alcon Contact Lens Case | Alcon Laboratories | 1998 | — |
| +1 | K040914 | Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics | Exero Products, Inc. | 2004 | — |
| +1 | K032309 | Novelens Contact Lens Cleaning Enhancement and Storage Accessory | Novelens, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRX? 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 LRX device
- #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K931620 | Opti-Free Contact Lens CaseSummary page 1…ill remain immersed under use conditions. Substantial Equivalence Comparison: The Alcon Contact Lens Case is identical in its intended use to the OPTI-FREE® Lens Case (K931620) and the OPTI-LENS® Lens Case (K915082). It is intended for storage of soft (hydrophilic), rigid gas permeable, and hard contact… | 1993 |
| * | K915082 | Opti-Lens (TM) Contact Lens CaseSummary page 1…s. Substantial Equivalence Comparison: The Alcon Contact Lens Case is identical in its intended use to the OPTI-FREE® Lens Case (K931620) and the OPTI-LENS® Lens Case (K915082). It is intended for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. Al… | 1992 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K974281 (Alcon Laboratories, 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRX
49in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRX
No recall names LRX since 2007.
Adverse event reports per year · LRX
1in 2021
MAUDE reports naming product code LRX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 103 | 0 | 1 |
| 2013 | 4 | 72 | 0 | 0 |
| 2014 | 3 | 249 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 5 | 49 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971618: Alcon Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971618
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026