Reported Reactions

Devices › Accessories, soft lens products

Device brand name · Clear care

Clear Care: medical device reports filed with FDA

264 reports name it, 2007–2022. Manufacturer given most often on reports: Ciba Vision. Product code LPN.

264
device reports naming the brand
0% of all MAUDE reports · about 14 a year
0
reports, 12 months to August 2026
0 in the 12 months before
1.9%
classified as malfunction
40.3% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

264 medical device reports received by FDA name the brand "Clear Care" (clear care); the manufacturer given most often on reports is Ciba Vision; received from March 2007 to October 2022. 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 (54.5%), other (32.6%) and malfunction (1.9%); across all accessories, soft lens products reports (product code LPN) death is recorded in 0% and malfunction in 40.3%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are improper or incorrect procedure or method (33%), inadequate instructions for non-healthcare professional (17.4%) and insufficient device problem information (9.5%). The patient problems coded most often are burning sensation, pain and red eye(s). 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

012Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 1Aug 2022: 0Sep 2022: 0Oct 2022: 2Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 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

038762007: 1020072008: 52009: 420092010: 152011: 1020112012: 452013: 1220132014: 252015: 7620152016: 182017: 1720172018: 72019: 820192020: 92022: 32022

Event type and report source

Event type, as classified on the report

Death0%0
Injury54.5%144
Malfunction1.9%5
Other32.6%86
Not given11%29

Who filed the report

Manufacturer report25.8%68
Voluntary report74.2%196
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 8,035 reports carrying product code LPN. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Improper or incorrect procedure or method8733%2.4%
Inadequate instructions for non-healthcare professional4617.4%1%
Insufficient device problem information259.5%4.7%
Device markings/labelling problema problem with the device markings or label145.3%1%
Packaging problem145.3%0.4%
Device operates differently than expectedthe device behaved unexpectedly114.2%1.2%
Patient-device incompatibilitythe device did not suit the patient93.4%0.9%
Manufacturing, packaging or shipping problem51.9%0.1%
Labelling, instructions for use or training problem41.5%0.7%
Device expiration issue31.1%0.4%
Device handling problem20.8%0.3%
Inappropriate or unexpected reset20.8%0%
Material integrity problema problem with the device material20.8%0.2%
Chemical problem10.4%0.1%
Device contamination with chemical or other material10.4%0.1%
Difficult or delayed activation10.4%0%
Difficult to removethe device was hard to remove10.4%0%
Human factors issue10.4%0%
Human-device interface problem10.4%0%
Inadequate user interface10.4%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)ReportsShare
Burning sensationa burning feeling9034.1%
Painpain, site not specified9034.1%
Red eye(s)4215.9%
Caustic/chemical burns3412.9%
Chemical exposure3111.7%
Swellingswelling269.8%
Eye injury238.7%
Burn(s)a burn186.8%
Eye burn134.9%
Irritationirritation124.5%
Blurred vision114.2%
Excessive tear production114.2%
Corneal abrasion103.8%
Loss of vision103.8%
Erythemaskin redness83%

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

In context

MeasureClear CareProduct code LPNAll MAUDE reports
Reports2648,03526,136,888
Share of that pool—3.3%0%
Classified as death, per 1,000 reports009
Classified as injury54.5%50.7%36.2%
Classified as malfunction1.9%40.3%62.3%
Filed by the manufacturer25.8%69.5%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 LPN

BrandReportsLatest 12 monthsClassified as death
Peroxiclear Hydrogen Peroxide Solution2,84500%
Opti-Free Replenish32400%
Renu With Moistureloc Multi-Purpose Solution38700%
Renu With Moisture Loc20100%
Complete Moisture Plus18800%
Amo Complete Moisture Plus17400%
Renu Multiplus Multi-Purpose Solution16100%
Allergan Cup17400%
Acuvue Oasys719270%
ISPAN Perfluoropropane (C3F8 gas)215350%
Alcon18020%
Focus Night & Day21500%
Totalcare6,66100%

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 Clear Care reports

How many FDA reports name Clear Care?

264 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 (54.5%), other (32.6%) and malfunction (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

improper or incorrect procedure or method (33%), inadequate instructions for non-healthcare professional (17.4%), insufficient device problem information (9.5%), device markings/labelling problem (5.3%) and packaging problem (5.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

voluntary reports (74.2%) and manufacturer reports (25.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Clear Care 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.