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FDA product code MFK · class 3 · Ophthalmic
Lens, multifocal intraocular: medical device reports filed with FDA
14,249 reports carry this product code, 1997–2026; 29 brands with a page.
- 14,249
- reports with this product code
- 0.1% of all MAUDE reports
- 1,313
- reports, 12 months to August 2026
- 1,263 in the 12 months before
- 16.6%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code MFK is FDA's classification for "Lens, multifocal intraocular" (ophthalmic panel), a class 3 device. 14,249 medical device reports carry this product code, 0.1% of the MAUDE database, from June 1997 to August 2026.
1,313 reports arrived in the 12 months to August 2026, close to the 1,263 of 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 (76.3%), malfunction (16.6%) and other (7%). 29 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Alcon Research - Huntington | 5,943 | 41.7% |
| Abbott Medical Optics | 1,998 | 14% |
| Amo Manufacturing Netherlands | 1,925 | 13.5% |
| Alcon Research / Huntington | 1,149 | 8.1% |
| Alcon Research /Huntington | 739 | 5.2% |
| Amo Puerto Rico Mfg | 674 | 4.7% |
| Johnson & Johnson Surgical Vision | 663 | 4.7% |
| Alcon Laboratories Ireland | 622 | 4.4% |
| Bausch + Lomb | 104 | 0.7% |
| Allergan | 42 | 0.3% |
| Advanced Medical Optics | 27 | 0.2% |
| Alcon Laboratories | 22 | 0.2% |
| Alcon Laboratories / Huntington | 20 | 0.1% |
| Alcon Laboratories /Huntington | 11 | 0.1% |
| Abbott | 2 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Insufficient device problem information | 1,125 | 7.9% |
| Device remains implanted | 758 | 5.3% |
| Scratched material | 700 | 4.9% |
| Breakthe device broke | 651 | 4.6% |
| Lens replacement | 312 | 2.2% |
| Device dislodged or dislocated | 292 | 2% |
| Device operates differently than expectedthe device behaved unexpectedly | 291 | 2% |
| Patient-device incompatibilitythe device did not suit the patient | 225 | 1.6% |
| Defective devicethe device was defective | 198 | 1.4% |
| Crackthe device cracked | 173 | 1.2% |
| Material opacification | 150 | 1.1% |
| Malposition of device | 139 | 1% |
| Explanted | 136 | 1% |
| Material split, cut or torn | 119 | 0.8% |
| Device contamination with chemical or other material | 104 | 0.7% |
| Inadequacy of device shape and/or size | 104 | 0.7% |
| Nonstandard device | 98 | 0.7% |
| Device difficult to setup or prepare | 93 | 0.7% |
| Material deformation | 78 | 0.5% |
| Unintended movement | 69 | 0.5% |
Questions about lens, multifocal intraocular reports
What is product code MFK?
FDA's classification code for "Lens, multifocal intraocular", class 3, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
14,249 reports through August 2026, 1,313 of them in the latest 12 months.
Which brands appear most often?
Acrysof Restor (2,015), Tecnis 1 Multifocal (1,919), Acrysof Iq Restor Singlepiece Iol (1,682), Tecnis Iol (1,226) and AcrySof IQ PanOptix Trifocal IOL (1,199). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.