Devices › Lens, multifocal intraocular
Device brand name · Lens multifocal intraocular
Clareon PanOptix Trifocal UV Absorbing Intraocular Lens: medical device reports filed with FDA
692 reports name it, 2022–2026. Manufacturer given most often on reports: Alcon Research - Huntington. Product code MFK.
- 692
- device reports naming the brand
- 0% of all MAUDE reports · about 173 a year
- 128
- reports, 12 months to August 2026
- 264 in the 12 months before
- 16.5%
- classified as malfunction
- 16.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
692 medical device reports received by FDA name the brand "Clareon PanOptix Trifocal UV Absorbing Intraocular Lens" (lens multifocal intraocular); the manufacturer given most often on reports is Alcon Research - Huntington; received from July 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
128 reports arrived in the 12 months to August 2026, down 52% from 264 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (83.5%) and malfunction (16.5%); across all lens, multifocal intraocular reports (product code MFK) death is recorded in 0% and malfunction in 16.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are scratched material (6.4%), device dislodged or dislocated (3.6%) and break (2.9%). The patient problems coded most often are blurred vision, visual disturbances and visual impairment. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 14,249 reports carrying product code MFK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Scratched material | 44 | 6.4% | 4.9% |
| Device dislodged or dislocated | 25 | 3.6% | 2% |
| Breakthe device broke | 20 | 2.9% | 4.6% |
| Crackthe device cracked | 14 | 2% | 1.2% |
| Defective devicethe device was defective | 13 | 1.9% | 1.4% |
| Failure to eject | 9 | 1.3% | 0.2% |
| Product quality problem | 7 | 1% | 0.2% |
| Defective component | 6 | 0.9% | 0.3% |
| Device difficult to setup or prepare | 6 | 0.9% | 0.7% |
| Malposition of device | 6 | 0.9% | 1% |
| Failure to deliverthe device did not deliver the dose or item | 5 | 0.7% | 0.3% |
| Optical decentration | 5 | 0.7% | 0.4% |
| Material split, cut or torn | 4 | 0.6% | 0.8% |
| Material twisted/bent | 4 | 0.6% | 0.3% |
| Application program problem: power calculation error | 3 | 0.4% | 0.1% |
| Dent in material | 3 | 0.4% | 0% |
| Failure to fold | 3 | 0.4% | 0.1% |
| Device contamination with chemical or other material | 2 | 0.3% | 0.7% |
| Failure to advance | 2 | 0.3% | 0.3% |
| Device damaged by another device | 1 | 0.1% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Blurred vision | 355 | 51.3% |
| Visual disturbances | 223 | 32.2% |
| Visual impairmentreduced vision | 193 | 27.9% |
| Halo | 80 | 11.6% |
| Headachehead pain | 18 | 2.6% |
| Posterior capsule opacification | 13 | 1.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 12 | 1.7% |
| Eye paineye pain | 12 | 1.7% |
| Vitreous floatersfloaters in vision | 12 | 1.7% |
| Diplopia/double vision | 11 | 1.6% |
| Dry eye(s) | 9 | 1.3% |
| Eye irritationeye irritation | 8 | 1.2% |
| Corneal edema | 7 | 1% |
| Dizzinesslight-headedness or unsteadiness | 7 | 1% |
| Macular edema | 7 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Clareon PanOptix Trifocal UV Absorbing Intraocular Lens | Product code MFK | All MAUDE reports |
|---|---|---|---|
| Reports | 692 | 14,249 | 26,136,888 |
| Share of that pool | — | 4.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 83.5% | 76.3% | 36.2% |
| Classified as malfunction | 16.5% | 16.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MFK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Acrysof Restor | 3,801 | 0 | 0% |
| Tecnis 1 Multifocal | 1,960 | 0 | 0% |
| Acrysof Iq Restor Singlepiece Iol | 1,682 | 8 | 0% |
| Tecnis Iol | 5,901 | 715 | 0% |
| AcrySof IQ PanOptix Trifocal IOL | 1,200 | 52 | 0% |
| Acrysof Iq Panoptix Uv Absorbing Trifocal Iol | 786 | 0 | 0% |
| AcrySof IQ PanOptix Toric Trifocal IOL | 619 | 28 | 0% |
| Tecnis Simplicity | 5,310 | 1,217 | 0% |
| Clareon PanOptix Trifocal Hydrophobic Intraocular Lens | 594 | 159 | 0% |
| Acrysof Iq Panoptix Toric Uv Absorbing Trifocal Iol | 542 | 0 | 0% |
| Tecnis | 3,082 | 0 | 0.1% |
| Tecnis Multifocal | 211 | 0 | 0% |
| Clareon IOL | 544 | 101 | 0% |
| Acrysof Restor Iol | 150 | 4 | 0% |
| Rezoom | 185 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Clareon PanOptix Trifocal UV Absorbing Intraocular Lens reports
How many FDA reports name Clareon PanOptix Trifocal UV Absorbing Intraocular Lens?
692 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 128 in the latest 12 months.
What kinds of events are reported?
injury (83.5%) and malfunction (16.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
scratched material (6.4%), device dislodged or dislocated (3.6%), break (2.9%), crack (2%) and defective device (1.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Clareon PanOptix Trifocal UV Absorbing Intraocular Lens was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.