Devices › Lens, multifocal intraocular
Device brand name · Intraocular lens
Acrysof Restor: medical device reports filed with FDA
3,801 reports name it, 2005–2015. Manufacturer given most often on reports: Alcon Research / Huntington. Product code MFK.
- 3,801
- device reports naming the brand
- 0% of all MAUDE reports · about 180 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 2.2%
- classified as malfunction
- 16.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
3,801 medical device reports received by FDA name the brand "Acrysof Restor" (intraocular lens); the manufacturer given most often on reports is Alcon Research / Huntington; received from May 2005 to June 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (65.6%), other (32.1%) and malfunction (2.2%); 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 device remains implanted (26.7%), insufficient device problem information (16.2%) and lens replacement (9%). The patient problems coded most often are visual disturbances, blurred vision 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
No report naming Acrysof Restor was received in the five years to August 2026; the latest was received in June 2015.
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 |
|---|---|---|---|
| Device remains implanted | 1,016 | 26.7% | 5.3% |
| Insufficient device problem information | 616 | 16.2% | 7.9% |
| Lens replacement | 343 | 9% | 2.2% |
| Malposition of device | 90 | 2.4% | 1% |
| Explanted | 71 | 1.9% | 1% |
| Lens (iol), scratch, mark on | 56 | 1.5% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 44 | 1.2% | 0.2% |
| Optical decentration | 40 | 1.1% | 0.4% |
| Breakthe device broke | 28 | 0.7% | 4.6% |
| Replace | 25 | 0.7% | 0.1% |
| Scratched material | 25 | 0.7% | 4.9% |
| Device dislodged or dislocated | 20 | 0.5% | 2% |
| Lens (iol), dislocated intraocular | 18 | 0.5% | 0.1% |
| Lens (iol), torn, split, cracked | 13 | 0.3% | 0% |
| Lens, malposition of | 12 | 0.3% | 0.1% |
| Defective devicethe device was defective | 9 | 0.2% | 1.4% |
| Haptic(s), broken | 8 | 0.2% | 0.1% |
| Crackthe device cracked | 6 | 0.2% | 1.2% |
| Device contamination with chemical or other material | 6 | 0.2% | 0.7% |
| Material opacification | 6 | 0.2% | 1.1% |
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 disturbances | 1,058 | 27.8% |
| Blurred vision | 1,027 | 27% |
| Visual impairmentreduced vision | 980 | 25.8% |
| Postoperative refraction, unexpected | 684 | 18% |
| Halo | 631 | 16.6% |
| Lens, replacement of | 329 | 8.7% |
| Surgical procedure, additional | 184 | 4.8% |
| Diplopiadouble vision | 165 | 4.3% |
| Other (for use when an appropriate patient code cannot be identified) | 97 | 2.6% |
| Treatment with medication(s) | 84 | 2.2% |
| Painpain, site not specified | 72 | 1.9% |
| Dry eye(s) | 69 | 1.8% |
| Headachehead pain | 54 | 1.4% |
| Vitreous floatersfloaters in vision | 51 | 1.3% |
| Decreased va, near (visual acuity) | 48 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Acrysof Restor | Product code MFK | All MAUDE reports |
|---|---|---|---|
| Reports | 3,801 | 14,249 | 26,136,888 |
| Share of that pool | — | 26.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 65.6% | 76.3% | 36.2% |
| Classified as malfunction | 2.2% | 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 |
|---|---|---|---|
| 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% |
| 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 Restor reports
How many FDA reports name Acrysof Restor?
3,801 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (65.6%), other (32.1%) and malfunction (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device remains implanted (26.7%), insufficient device problem information (16.2%), lens replacement (9%), malposition of device (2.4%) and explanted (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 Acrysof Restor 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.