Reported Reactions

Devices › Lenses, soft contact, daily wear

Device brand name · Lenses soft contact daily wear

Dailies Total 1: medical device reports filed with FDA

195 reports name it, 2012–2026. Manufacturer given most often on reports: Ciba Vision. Product code LPL.

195
device reports naming the brand
0% of all MAUDE reports · about 14 a year
12
reports, 12 months to August 2026
25 in the 12 months before
0%
classified as malfunction
4.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 195 reports that name the brand "Dailies Total 1" (lenses soft contact daily wear), received between July 2012 and July 2026; the manufacturer given most often on reports is Ciba Vision. Spellings of one product vary from report to report.

12 reports arrived in the 12 months to August 2026, down 52% from 25 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 (99.5%); across all lenses, soft contact, daily wear reports (product code LPL) death is recorded in 0% and malfunction in 4.9%. 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 (14.9%), patient-device incompatibility (3.6%) and improper or incorrect procedure or method (3.1%). The patient problems coded most often are corneal ulcer, red eye(s) and pain. 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

059Sep 2021: 0Oct 2021: 1Nov 2021: 2Dec 2021: 12022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 1Jun 2022: 1Jul 2022: 0Aug 2022: 1Sep 2022: 1Oct 2022: 0Nov 2022: 0Dec 2022: 12023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 1May 2023: 0Jun 2023: 1Jul 2023: 2Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 4Dec 2023: 32024Jan 2024: 0Feb 2024: 1Mar 2024: 3Apr 2024: 0May 2024: 1Jun 2024: 1Jul 2024: 2Aug 2024: 0Sep 2024: 9Oct 2024: 6Nov 2024: 0Dec 2024: 22025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 1May 2025: 3Jun 2025: 0Jul 2025: 3Aug 2025: 1Sep 2025: 4Oct 2025: 1Nov 2025: 0Dec 2025: 22026Jan 2026: 0Feb 2026: 0Mar 2026: 2Apr 2026: 1May 2026: 0Jun 2026: 1Jul 2026: 1Aug 2026: 0

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

013252012: 320122013: 152014: 2020142015: 152016: 1720162017: 182018: 1520182019: 162020: 820202021: 72022: 520222023: 112024: 2520242025: 152026: 52026

Event type and report source

Event type, as classified on the report

Death0%0
Injury99.5%194
Malfunction0%0
Other0%0
Not given0.5%1

Who filed the report

Manufacturer report99.5%194
Voluntary report0.5%1
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 4,882 reports carrying product code LPL. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Insufficient device problem information2914.9%13.4%
Patient-device incompatibilitythe device did not suit the patient73.6%3.4%
Improper or incorrect procedure or method63.1%2.5%
Contamination21%0.6%
Device operates differently than expectedthe device behaved unexpectedly21%2.9%
Material frayed21%0.1%
Material twisted/bent21%0.1%
Naturally worn21%0.2%
Difficult to removethe device was hard to remove10.5%1.7%
Material deformation10.5%0.2%
Material opacification10.5%0%
Material split, cut or torn10.5%1.1%
Peeled/delaminated10.5%0%
Physical resistance/sticking10.5%0%
Tear, rip or hole in device packaging10.5%0%
Therapeutic or diagnostic output failure10.5%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
Corneal ulcer11257.4%
Red eye(s)4221.5%
Painpain, site not specified2814.4%
Corneal infiltrates2412.3%
Eye paineye pain199.7%
Discomfortdiscomfort157.7%
Foreign body sensation in eye147.2%
Corneal abrasion115.6%
Irritationirritation115.6%
Discharge105.1%
Keratitis105.1%
Blurred vision94.6%
Excessive tear production94.6%
Photophobiasensitivity to light84.1%
Scar tissue84.1%

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

In context

MeasureDailies Total 1Product code LPLAll MAUDE reports
Reports1954,88226,136,888
Share of that pool—4%0%
Classified as death, per 1,000 reports009
Classified as injury99.5%90.9%36.2%
Classified as malfunction0%4.9%62.3%
Filed by the manufacturer99.5%79.4%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 LPL

BrandReportsLatest 12 monthsClassified as death
Acuvue Oasys719270%
Avaira Sphere Enfilcon A15800%
Air Optix Night & Day Aqua15190%
Focus Night & Day21500%
Acuvue 217450%
ACUVUE OASYS for ASTIGMATISM261180%
Complete Moisture Plus18800%
AdvanCE22082.7%
Biofinity Toric (comfilcon A)212160%
Amo Complete Moisture Plus17400%
Ciba Vision Memory Lens29400%
Clear Care26400%

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 Dailies Total 1 reports

How many FDA reports name Dailies Total 1?

195 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.

What kinds of events are reported?

injury (99.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (14.9%), patient-device incompatibility (3.6%), improper or incorrect procedure or method (3.1%), contamination (1%) and device operates differently than expected (1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.5%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Dailies Total 1 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.