ClearIt Anti-Fog Kit PS003Recalls & reported problems
Preservation Solutions Inc · A sterile kit containing a 6cc vial of anti-fog solution and sponge with radiopaque marker, pack of 10 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10810805000146), received between Feb 25, 2019 and Feb 25, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Protective Measures Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Protective Measures Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2019Protective Measures Problem
DISTRIBUTION COMPANY NOTIFIED PRESERVATION SOLUTIONS, INC. (PSI, MANUFACTURER) ON JANUARY 18, 2019 OF A COMPLAINT THAT INCLUDED AN ALLEGATION FROM AN END USER THAT THE CLEARIT ANTI-FOG SOLUTION KIT DEVICE WAS NOT FUNCTIONING AS INTENDED. THE DEVICE IS TO BE USED TO HELP PREVENT THE FOGGING OF ENDOSCOPE LENS DURING PROCEDURES. THE ALLEGATION WAS THAT THE CLEARIT ANTI-FOG SOLUTION DID NOT PREVENT THE LENS FROM FOGGING DURING PROCEDURE. ADDITIONAL FOLLOW-UP INFORMATION FROM THE DISTRIBUTOR REGARDING THE COMPLAINT ON JANUARY 21, 2019 THAT INCLUDED INFORMATION THAT THE ALLEGED INCIDENT TOOK PLACE ON (B)(6) 2018 THAT INCLUDED A STATEMENT REGARDING THE IMPACT OF THE COMPLAINT AS "PATIENT SAFETY ISSUE NOTED". PSI REQUESTED ADDITIONAL INFORMATION REGARDING THIS STATEMENT AND FURTHER INFORMATION WAS PROVIDED FROM THE END USER VIA THE DISTRIBUTOR THAT INDICATED IF THE ANTI-FOG SOLUTION IS INEFFECTIVE, TIME IS WASTED CLEARING THE LENS OF FOG. THIS WOULD RESULT IN REPEATED ENTRY INTO THE TRACHEA AND BRONCHUS WITH THE ENDOSCOPE WHICH COULD POTENTIALLY CAUSE TRAUMA TO THE AIRWAY AND PROLONG A PROCEDURE. AS OF (B)(6) 2019, PSI IS AWAITING THE RETURN OF UNUSED PRODUCT FROM THE END USER/DISTRIBU
Patient problems: No Information
MAUDE report 8367379 ↗
Other Anti Fog Solution And Accessories, Endoscopy devices
- Dr. Fog® Treated Sponge DF-3120Aspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy11 reports
- Medline Anti-Fog, Sterile MD-1001EAspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy3 reports
- DeRoyal 28-0101BDeroyal Industries, Inc. · Anti fog solution and accessories, endoscopy2 reports
- Dr. Fog® Solution With Sponge DF-3100Aspen Surgical Products, Inc. · Anti fog solution and accessories, endoscopy1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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