Reported Reactions

Devices › Extended depth of focus intraocular lens

Device brand name · Multifocal iols

Tecnis Symfony Toric: medical device reports filed with FDA

1,096 reports name it, 2016–2021. Manufacturer given most often on reports: Johnson & Johnson Surgical Vision. Product code POE.

1,096
device reports naming the brand
0% of all MAUDE reports · about 111 a year
0
reports, 12 months to August 2026
0 in the 12 months before
7.3%
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 1,096 reports that name the brand "Tecnis Symfony Toric" (multifocal iols), received between August 2016 and April 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 (92.7%) and malfunction (7.3%); 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 unintended movement (12.6%), inadequacy of device shape and/or size (7.1%) and break (1.9%). 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 Toric was received in the five years to August 2026; the latest was received in April 2021.

By year received

01553102016: 4120162017: 28420172018: 31020182019: 30720192020: 14620202021: 82021

Event type and report source

Event type, as classified on the report

Death0%0
Injury92.7%1,016
Malfunction7.3%80
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.9%1,095
Voluntary report0.1%1
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Unintended movement13812.6%2.7%
Inadequacy of device shape and/or size787.1%3%
Breakthe device broke211.9%3.8%
Scratched material151.4%6.1%
Device contamination with chemical or other material90.8%1.1%
Device dislodged or dislocated90.8%2.7%
Mechanical problema mechanical problem50.5%0.4%
Migration or expulsion of device50.5%0.3%
Crackthe device cracked40.4%1.3%
Torn material40.4%0.2%
Device operates differently than expectedthe device behaved unexpectedly20.2%0%
Incorrect measurementthe device measured wrongly20.2%0.1%
Invalid sensing20.2%0.2%
Malposition of device20.2%0.6%
Material opacification20.2%0.8%
Positioning problem20.2%0%
Product quality problem20.2%0.7%
Unexpected therapeutic results20.2%0.1%
Arcing10.1%0%
Contamination10.1%0.2%

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)ReportsShare
Halo25523.3%
Visual disturbances22820.8%
Blurred vision18416.8%
Visual impairmentreduced vision988.9%
No patient involvement222%
Vitrectomy211.9%
Capsular bag tear181.6%
Dry eye(s)181.6%
Therapeutic effects, unexpected151.4%
Inflammationinflammation40.4%
Irritationirritation40.4%
Corneal edema30.3%
Discomfortdiscomfort30.3%
Headachehead pain30.3%
Vitreous floatersfloaters in vision30.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureTecnis Symfony ToricProduct code POEAll MAUDE reports
Reports1,0965,95226,136,888
Share of that pool—18.4%0%
Classified as death, per 1,000 reports009
Classified as injury92.7%79.8%36.2%
Classified as malfunction7.3%20.2%62.3%
Filed by the manufacturer99.9%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

BrandReportsLatest 12 monthsClassified as death
Tecnis Symfony1,62300%
AcrySof IQ Vivity Extended Vision IOL676500%
Clareon Vivity Extended Vision UV Absorbing IOL4491130%
Acrysof Iq Vivity Toric Extended Vision Iol351310%
Tecnis Iol5,9017150%
Acrysof Iq Vivity Extended Vision Uv Absorbing Iol29600%
Clareon Vivity Extended Vision Hydrophobic IOL297920%
Acrysof Iq Vivity Toric Extended Vision Uv Absorbing Iol20620%
Tecnis Simplicity5,3101,2170%
Tecnis 1 Multifocal1,96000%
Tecnis3,08200.1%
Tecnis 1-Piece2,25900%
Tecnis Itec Preloaded 1-Piece Iol2,43500%
UNK_Monofocal IOL172430%

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 Toric reports

How many FDA reports name Tecnis Symfony Toric?

1,096 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 (92.7%) and malfunction (7.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

unintended movement (12.6%), inadequacy of device shape and/or size (7.1%), break (1.9%), scratched material (1.4%) and device contamination with chemical or other material (0.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Tecnis Symfony Toric 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.