Devices › Lens, multifocal intraocular
Device brand name · Lens multifocal intraocular
Acrysof Iq Restor Singlepiece Iol: medical device reports filed with FDA
1,682 reports name it, 2015–2026. Manufacturer given most often on reports: Alcon Research - Huntington. Product code MFK.
- 1,682
- device reports naming the brand
- 0% of all MAUDE reports · about 147 a year
- 8
- reports, 12 months to August 2026
- 19 in the 12 months before
- 10%
- classified as malfunction
- 16.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,682 reports that name the brand "Acrysof Iq Restor Singlepiece Iol" (lens multifocal intraocular), received between February 2015 and July 2026; the manufacturer given most often on reports is Alcon Research - Huntington. Spellings of one product vary from report to report.
8 reports arrived in the 12 months to August 2026, down 58% from 19 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 (90%) and malfunction (10%); 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 insufficient device problem information (20.3%), device operates differently than expected (13.6%) and nonstandard device (5.6%). The patient problems coded most often are visual impairment, 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 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 |
|---|---|---|---|
| Insufficient device problem information | 341 | 20.3% | 7.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 228 | 13.6% | 2% |
| Nonstandard device | 95 | 5.6% | 0.7% |
| Patient-device incompatibilitythe device did not suit the patient | 92 | 5.5% | 1.6% |
| Scratched material | 39 | 2.3% | 4.9% |
| Material opacification | 30 | 1.8% | 1.1% |
| Unexpected therapeutic results | 26 | 1.5% | 0.3% |
| Device dislodged or dislocated | 22 | 1.3% | 2% |
| Breakthe device broke | 19 | 1.1% | 4.6% |
| Defective devicethe device was defective | 17 | 1% | 1.4% |
| Therapeutic or diagnostic output failure | 13 | 0.8% | 0.4% |
| Malposition of device | 12 | 0.7% | 1% |
| Material discolored | 10 | 0.6% | 0.3% |
| Material integrity problema problem with the device material | 9 | 0.5% | 0.1% |
| Crackthe device cracked | 8 | 0.5% | 1.2% |
| Device contamination with chemical or other material | 8 | 0.5% | 0.7% |
| Mechanical problema mechanical problem | 8 | 0.5% | 0.4% |
| Positioning problem | 8 | 0.5% | 0.3% |
| Material deformation | 7 | 0.4% | 0.5% |
| Contamination /decontamination problem | 6 | 0.4% | 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 |
|---|---|---|
| Visual impairmentreduced vision | 420 | 25% |
| Blurred vision | 329 | 19.6% |
| Inflammationinflammation | 279 | 16.6% |
| Halo | 140 | 8.3% |
| Endophthalmitisinfection inside the eye | 113 | 6.7% |
| Painpain, site not specified | 110 | 6.5% |
| Visual disturbances | 95 | 5.6% |
| Loss of vision | 84 | 5% |
| Uveitis | 52 | 3.1% |
| Red eye(s) | 35 | 2.1% |
| Complaint, ill-defined | 34 | 2% |
| Discomfortdiscomfort | 33 | 2% |
| Dry eye(s) | 32 | 1.9% |
| Corneal edema | 29 | 1.7% |
| Failure of implant | 29 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Acrysof Iq Restor Singlepiece Iol | Product code MFK | All MAUDE reports |
|---|---|---|---|
| Reports | 1,682 | 14,249 | 26,136,888 |
| Share of that pool | — | 11.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 90% | 76.3% | 36.2% |
| Classified as malfunction | 10% | 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% |
| 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% |
| Clareon PanOptix Trifocal UV Absorbing Intraocular Lens | 692 | 128 | 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 Acrysof Iq Restor Singlepiece Iol reports
How many FDA reports name Acrysof Iq Restor Singlepiece Iol?
1,682 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 8 in the latest 12 months.
What kinds of events are reported?
injury (90%) and malfunction (10%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (20.3%), device operates differently than expected (13.6%), nonstandard device (5.6%), patient-device incompatibility (5.5%) and scratched material (2.3%). 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 Acrysof Iq Restor Singlepiece Iol 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.