Devices › Extended depth of focus intraocular lens
Device brand name · Multifocal iols
Tecnis Symfony: medical device reports filed with FDA
1,623 reports name it, 2016–2021. Manufacturer given most often on reports: Johnson & Johnson Surgical Vision. Product code POE.
- 1,623
- device reports naming the brand
- 0% of all MAUDE reports · about 164 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 5.8%
- classified as malfunction
- 20.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,623 reports that name the brand "Tecnis Symfony" (multifocal iols), received between August 2016 and August 2021; the manufacturer given most often on reports is Johnson & Johnson Surgical Vision. Spellings of one product vary from report to report.
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 (94.2%) and malfunction (5.8%); across all extended depth of focus intraocular lens reports (product code POE) death is recorded in 0% and malfunction in 20.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are inadequacy of device shape and/or size (6.5%), unintended movement (1.7%) and device dislodged or dislocated (1.6%). The patient problems coded most often are halo, visual disturbances and blurred vision. 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 Tecnis Symfony was received in the five years to August 2026; the latest was received in August 2021.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,952 reports carrying product code POE. 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 |
|---|---|---|---|
| Inadequacy of device shape and/or size | 106 | 6.5% | 3% |
| Unintended movement | 28 | 1.7% | 2.7% |
| Device dislodged or dislocated | 26 | 1.6% | 2.7% |
| Scratched material | 24 | 1.5% | 6.1% |
| Breakthe device broke | 21 | 1.3% | 3.8% |
| Device contamination with chemical or other material | 16 | 1% | 1.1% |
| Migration or expulsion of device | 13 | 0.8% | 0.3% |
| Crackthe device cracked | 9 | 0.6% | 1.3% |
| Mechanical problema mechanical problem | 8 | 0.5% | 0.4% |
| Contamination /decontamination problem | 7 | 0.4% | 0.2% |
| Invalid sensing | 6 | 0.4% | 0.2% |
| Product quality problem | 6 | 0.4% | 0.7% |
| Torn material | 4 | 0.2% | 0.2% |
| Contamination | 3 | 0.2% | 0.2% |
| Device markings/labelling problema problem with the device markings or label | 3 | 0.2% | 0.2% |
| Incorrect measurementthe device measured wrongly | 3 | 0.2% | 0.1% |
| Material split, cut or torn | 3 | 0.2% | 1.1% |
| Dent in material | 2 | 0.1% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.1% | 0% |
| Expulsion | 2 | 0.1% | 0% |
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 |
|---|---|---|
| Halo | 425 | 26.2% |
| Visual disturbances | 378 | 23.3% |
| Blurred vision | 259 | 16% |
| Visual impairmentreduced vision | 211 | 13% |
| Dry eye(s) | 41 | 2.5% |
| Vitrectomy | 40 | 2.5% |
| No patient involvement | 26 | 1.6% |
| Capsular bag tear | 25 | 1.5% |
| Painpain, site not specified | 19 | 1.2% |
| Therapeutic effects, unexpected | 18 | 1.1% |
| Corneal edema | 13 | 0.8% |
| Discomfortdiscomfort | 10 | 0.6% |
| Headachehead pain | 10 | 0.6% |
| Intraocular pressure increasedraised pressure in the eye | 10 | 0.6% |
| Foreign body sensation in eye | 9 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Tecnis Symfony | Product code POE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,623 | 5,952 | 26,136,888 |
| Share of that pool | — | 27.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 94.2% | 79.8% | 36.2% |
| Classified as malfunction | 5.8% | 20.2% | 62.3% |
| Filed by the manufacturer | 100% | 99.9% | 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 POE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Tecnis Symfony Toric | 1,096 | 0 | 0% |
| AcrySof IQ Vivity Extended Vision IOL | 676 | 50 | 0% |
| Clareon Vivity Extended Vision UV Absorbing IOL | 449 | 113 | 0% |
| Acrysof Iq Vivity Toric Extended Vision Iol | 351 | 31 | 0% |
| Tecnis Iol | 5,901 | 715 | 0% |
| Acrysof Iq Vivity Extended Vision Uv Absorbing Iol | 296 | 0 | 0% |
| Clareon Vivity Extended Vision Hydrophobic IOL | 297 | 92 | 0% |
| Acrysof Iq Vivity Toric Extended Vision Uv Absorbing Iol | 206 | 2 | 0% |
| Tecnis Simplicity | 5,310 | 1,217 | 0% |
| Tecnis 1 Multifocal | 1,960 | 0 | 0% |
| Tecnis | 3,082 | 0 | 0.1% |
| Tecnis 1-Piece | 2,259 | 0 | 0% |
| Tecnis Itec Preloaded 1-Piece Iol | 2,435 | 0 | 0% |
| UNK_Monofocal IOL | 172 | 43 | 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 Tecnis Symfony reports
How many FDA reports name Tecnis Symfony?
1,623 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 (94.2%) and malfunction (5.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
inadequacy of device shape and/or size (6.5%), unintended movement (1.7%), device dislodged or dislocated (1.6%), scratched material (1.5%) and break (1.3%). 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 Tecnis Symfony 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.