Drugs › Non-Standardized chemical allergen
Brand name · Carboxymethylcellulose sodium, glycerin
Refresh Tears Pf: adverse event reports filed with FDA
338 reports list it as a suspect or interacting product, 2024–2026. Class: Non-Standardized chemical allergen.
- 338
- reports as suspect product
- 0% of all reports · about 185 a year
- 192
- reports, 12 months to June 2026
- 146 in the 12 months before
- 16%
- marked serious by the reporter
- 7.3% across the class
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
Between September 2024 and June 2026, 338 adverse event reports received by FDA list the brand name Refresh Tears Pf (carboxymethylcellulose sodium, glycerin) as a suspect or interacting product. Reports that mention it only as a concomitant medication (38) are left out of every figure here.
In the 12 months to June 2026, 192 reports listed it, up 32% from 146 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 185 reports a year and 0% of the 20,646,523 reports in the database, and 2.1% of the reports for the non-Standardized chemical allergen class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded product odour abnormal (30.8%), product container issue (20.7%) and eye irritation (16%). A report can list several reactions, so shares add to more than 100%; 59 different terms appear across these reports. Product odour abnormal is recorded in 30.8% of these reports, with no counterpart in the median non-Standardized chemical allergen drug (0%).
16% of the reports are marked serious by the reporter (7.3% across the class); 0% record death among the outcomes and 0.3% record hospitalisation, as reported. 99.7% of the reports came from consumers, and the largest patient age group is 75 and over (7.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Refresh Tears Pf reports recording the termmedian drug in non-standardized chemical allergen
- Product odour abnormalthe product smelt odd30.8%104
- Product container issuea problem with the container20.7%70
- Eye irritationeye irritation16%54
- Off label useused for a purpose or in a way not on the label12.4%42
- Cataractclouding of the eye lens8.6%29
- Arthritis5.9%20
- Ocular hyperaemiaa red eye5.3%18
- Dry eyedry eye4.4%15
- Eye paineye pain4.4%15
- Vision blurredblurred vision4.4%15
- Eye pruritus4.1%14
- Product storage errorthe product was stored wrongly3.6%12
- Wrong technique in product usage processthe product was used in the wrong way3.3%11
- Drug ineffectivethe medicine did not work as expected2.7%9
- Product contaminationcontamination of the product2.7%9
- Visual impairmentreduced vision2.7%9
- Eye disorder2.1%7
- Burning sensationa burning feeling1.8%6
- Ocular discomfort1.8%6
- Device difficult to usethe device was hard to use1.5%5
- Eye infection1.5%5
- Macular degenerationa disease of the central retina1.5%5
- Pain in extremitypain in an arm or leg1.5%5
- Eye discharge1.2%4
- Eye operation1.2%4
- Foreign body in eyesomething in the eye1.2%4
- Glaucomaraised pressure in the eye1.2%4
Top 30 of 59 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the non-standardized chemical allergen class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 15,731 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Dry eye | 152 | 45% |
| Eye irritation | 4 | 1.2% |
| Macular degeneration | 2 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 338 reports.
In context
| Measure | Refresh Tears Pf | Non-Standardized chemical allergen | All reports |
|---|---|---|---|
| Reports as suspect product | 338 | 15,731 | 20,646,523 |
| Share of that pool | — | 2.1% | 0% |
| Reports, latest 12 months | 192 | — | 1,332,454 |
| Marked serious | 16% | 7.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 2 | 91 |
| Hospitalisation recorded, per 1,000 reports | 3 | 29 | 213 |
| Consumer-filed share | 99.7% | 94.7% | 45.8% |
| Top term, share of reports | Product odour abnormal 30.8% | median 0% | 0% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the non-standardized chemical allergen class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Abreva | brand | 13,634 | 96 | 0.7% |
| Refresh Optive | brand | 1,206 | 54 | 18.8% |
| Glycerin | generic | 891 | 58 | 93.2% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Refresh Tears Pf reports
How many adverse event reports has FDA received for Refresh Tears Pf?
338 reports list Refresh Tears Pf as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 192 of them arrived in the latest 12 months. Another 38 list it only as a concomitant medication.
What reactions are recorded in Refresh Tears Pf reports?
product odour abnormal (30.8%), product container issue (20.7%), eye irritation (16%), off label use (12.4%) and poor quality product administered (10.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Refresh Tears Pf was responsible.
How serious are the reports?
16% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 0.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (99.7%) and other health professional (0.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Refresh Tears Pf rising?
192 reports in the 12 months to June 2026, up 32% from 146 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Refresh Tears Pf was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Refresh Tears Pf?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Refresh Tears Pf as a suspect or interacting product; reports listing it only as a concomitant medication (38) are excluded. 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.