Devices › Lens, intraocular, toric optics
Device brand name · Lens intraocular toric optics
Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System: medical device reports filed with FDA
567 reports name it, 2022–2026. Manufacturer given most often on reports: Alcon Laboratories Ireland. Product code MJP.
- 567
- device reports naming the brand
- 0% of all MAUDE reports · about 142 a year
- 235
- reports, 12 months to August 2026
- 283 in the 12 months before
- 94.4%
- classified as malfunction
- 42% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 567 reports that name the brand "Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System" (lens intraocular toric optics), received between July 2022 and August 2026; the manufacturer given most often on reports is Alcon Laboratories Ireland. Spellings of one product vary from report to report.
235 reports arrived in the 12 months to August 2026, down 17% from 283 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 malfunction (94.4%) and injury (5.6%); across all lens, intraocular, toric optics reports (product code MJP) death is recorded in 0% and malfunction in 42%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material discolored (25.6%), device difficult to setup or prepare (18.2%) and failure to deliver (12.9%). The patient problems coded most often are corneal edema, blurred vision and inflammation. 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 8,214 reports carrying product code MJP. 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 |
|---|---|---|---|
| Material discolored | 145 | 25.6% | 3.3% |
| Device difficult to setup or prepare | 103 | 18.2% | 2.8% |
| Failure to deliverthe device did not deliver the dose or item | 73 | 12.9% | 2.5% |
| Failure to advance | 48 | 8.5% | 1.5% |
| Material twisted/bent | 46 | 8.1% | 2% |
| Device damaged by another device | 27 | 4.8% | 1% |
| Inaccurate delivery | 25 | 4.4% | 0.9% |
| Failure to eject | 23 | 4.1% | 0.7% |
| Failure to fold | 18 | 3.2% | 0.6% |
| Failure to unfold or unwrap | 18 | 3.2% | 0.6% |
| Defective devicethe device was defective | 14 | 2.5% | 2.6% |
| Product quality problem | 11 | 1.9% | 1.3% |
| Scratched material | 10 | 1.8% | 7.8% |
| Breakthe device broke | 7 | 1.2% | 8.8% |
| Material deformation | 7 | 1.2% | 0.9% |
| Activation problem | 5 | 0.9% | 0.1% |
| Failure to prime | 5 | 0.9% | 0.1% |
| Defective component | 4 | 0.7% | 0.6% |
| Device dislodged or dislocated | 4 | 0.7% | 5.9% |
| Unintended ejection | 3 | 0.5% | 0.1% |
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 |
|---|---|---|
| Corneal edema | 7 | 1.2% |
| Blurred vision | 6 | 1.1% |
| Inflammationinflammation | 6 | 1.1% |
| Toxic anterior segment syndrome (tass) | 4 | 0.7% |
| Visual disturbances | 4 | 0.7% |
| Visual impairmentreduced vision | 4 | 0.7% |
| Capsular bag tear | 3 | 0.5% |
| Eye injury | 2 | 0.4% |
| Intraocular pressure increasedraised pressure in the eye | 2 | 0.4% |
| Corneal endothelial cell loss | 1 | 0.2% |
| Diplopia/double vision | 1 | 0.2% |
| Endophthalmitisinfection inside the eye | 1 | 0.2% |
| Red eye(s) | 1 | 0.2% |
| Uveitis | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System | Product code MJP | All MAUDE reports |
|---|---|---|---|
| Reports | 567 | 8,214 | 26,136,888 |
| Share of that pool | — | 6.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 5.6% | 54.5% | 36.2% |
| Classified as malfunction | 94.4% | 42% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 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 MJP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| AcrySof IQ Toric Singlepiece IOL | 1,767 | 60 | 0% |
| Tecnis Iol | 5,901 | 715 | 0% |
| Clareon Toric IOL | 567 | 207 | 0% |
| Clareon PanOptix Toric Trifocal UV Absorbing IOL | 488 | 75 | 0% |
| Clareon PanOptix Toric Trifocal Hydrophobic IOL | 430 | 136 | 0% |
| Clareon Vivity Toric Extended Vision UV Absorbing IOL | 388 | 95 | 0% |
| Clareon Vivity Toric Extended Vision Hydrophobic IOL | 314 | 119 | 0% |
| Clareon Toric UV Absorbing IOL | 309 | 126 | 0% |
| Acrysof Restor Toric Singlepiece Iol | 269 | 0 | 0% |
| Acrysof Iq Toric | 1,905 | 0 | 0% |
| Acrysof Toric | 638 | 0 | 0% |
| Trulign Toric Posterior Chamber Iol | 179 | 0 | 0% |
| CLAREON PANOPTIX PRO Trifocal TORIC UV Absorbing IOL w/AutonoME Delivery System | 150 | 146 | 0% |
| Tecnis | 3,082 | 0 | 0.1% |
| Tecnis Symfony Toric | 1,096 | 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 Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System reports
How many FDA reports name Clareon Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System?
567 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 235 in the latest 12 months.
What kinds of events are reported?
malfunction (94.4%) and injury (5.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material discolored (25.6%), device difficult to setup or prepare (18.2%), failure to deliver (12.9%), failure to advance (8.5%) and material twisted/bent (8.1%). 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 Toric Aspheric Hydrophobic Acrylic IOL with AutonoME Delivery System 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.