REVITALENS 93686HZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827444001000), received between Apr 28, 2017 and Jul 29, 2019 — classified as 3 injuries.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE CONSUMER INITIALLY REPORTED THAT BLINK REVITALENS MULTIPURPOSE SOLUTION BURNS HER EYES WHEN SHE USED IT TO CLEAN HER CONTACT LENSES. PER HER DOCTOR¿S RECOMMENDATION SHE STOPPED USING THE SOLUTION AND THE SYMPTOMS ABATED. REPORTEDLY, SHE ONLY USED THE PRODUCT TWICE WITHIN THE LAST COUPLE OF WEEKS, BUT COULD NOT REMEMBER WHEN SHE PURCHASED IT. THROUGH FOLLOW-UP THE CONSUMER EXPLAINED THAT HER DOCTOR HAD PRESCRIBED EYE DROPS, SHE BELIEVES THEY WERE PATADAY. PER THE CONSUMER, THE DOCTOR TOLD HER THAT THIS SOLUTION CAN BE STRONG FOR SOME PEOPLE, THAT EVERYBODY IS DIFFERENT, AND HE SUGGESTED A MILDER SOLUTION. WHEN ASKED HOW LONG SHE EXPERIENCED THE SYMPTOM OF BURNING SHE SAID A COUPLE DAYS. THE CONSUMER REPORTED THAT DUE TO HER SYMPTOMS SHE RUBBED HER EYES WHICH MAY HAVE ADDED TO THE ISSUE. ADDITIONALLY, CONSUMER EXPLAINED SHE ¿WASHES¿ THE LENS CASE. SHE EMPTIES THE SOLUTION AND THEN USES A PAPER TOWEL TO DRY THE CASE. SHE ALSO STATED SHE SOMETIMES PUTS SOLUTION ON THE PAPER TOWEL AND THEN WIPES THE LENS CASE OUT. CONSUMER WEARS SOFT CONTACT LENSES AND DOES NOT SLEEP OR SWIM IN THEM. THE CONSUMER WAS INFORMED THAT THE LOT NUMBER SHE PROVIDED EXPIRED IN MARCH 2017, SHE IMMEDIATE

  Patient problems: Burning Sensation

  MAUDE report 8839669 ↗
• InjuryApr 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A DOCTOR'S OFFICE, THAT A SAMPLE BOTTLE OF BLINK REVITALENS, LOT: ZB06792 EXPIRATION: 1/2018 WAS USED DURING THE MONTH AND TWO PATIENTS THAT SOAKED THEIR LENSES WHILE AT THE DOCTOR'S OFFICE EXPERIENCED BURNING, REDNESS AND A CHEMICAL EXPOSURE FORM OF KERATITIS. ONE PATIENT'S LENSES WERE TWO DAYS OLD AND THE OTHER PATIENT'S LENSES WERE ALSO FAIRLY NEW. BOTH PATIENTS HAD PREVIOUSLY SOAKED THEIR LENSES USING A DIFFERENT BRAND OF SOLUTION. APPROXIMATELY THREE OTHER PATIENTS WHILE AT DOCTOR'S OFFICE HAD THEIR LENSES ALSO SOAKED IN SOLUTION USING THIS SAME SAMPLE BOTTLE AND DID NOT HAVE ANY ISSUES. THESE PATIENTS HAD ALSO PREVIOUSLY SOAKED THEIR LENSES USING A DIFFERENT BRAND OF SOLUTION. THE TWO PATIENTS THAT HAD A REACTION, HAD IT WITHIN A COUPLE OF MINUTES AFTER PUTTING THEIR LENSES IN. THE DOCTOR FLUSHED OUT THEIR EYES WITH SALINE AND THEIR EYES STARTED TO FEEL RELIEF WITHIN APPROXIMATELY TEN MINUTES. BY THE FOLLOWING DAY BOTH PATIENTS WERE FINE. NO OTHER TREATMENTS OR MEDICATIONS WERE GIVEN. DOCTOR ONLY SUGGESTED USING ARTIFICIAL TEARS, BUT DIDN'T PROVIDE THIS TO THE PATIENTS. AS EVENT INDICATES TWO (2) PATIENTS EXPERIENCED A REACTION TO THE PRODUCT, TWO MDRS WILL

  Patient problems: Burning Sensation; Irritation; Keratitis

  MAUDE report 6533199 ↗
• InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A DOCTOR'S OFFICE, THAT A SAMPLE BOTTLE OF BLINK REVITALENS, LOT: ZB06792 EXPIRATION: 1/2018 WAS USED DURING THE MONTH AND TWO PATIENTS THAT SOAKED THEIR LENSES WHILE AT THE DOCTOR'S OFFICE EXPERIENCED BURNING, REDNESS AND A CHEMICAL EXPOSURE FORM OF KERATITIS. ONE PATIENT'S LENSES WERE TWO DAYS OLD AND THE OTHER PATIENT'S LENSES WERE ALSO FAIRLY NEW. BOTH PATIENTS HAD PREVIOUSLY SOAKED THEIR LENSES USING A DIFFERENT BRAND OF SOLUTION. APPROXIMATELY THREE OTHER PATIENTS WHILE AT DOCTOR'S OFFICE HAD THEIR LENSES ALSO SOAKED IN SOLUTION USING THIS SAME SAMPLE BOTTLE AND DID NOT HAVE ANY ISSUES. THESE PATIENTS HAD ALSO PREVIOUSLY SOAKED THEIR LENSES USING A DIFFERENT BRAND OF SOLUTION. THE TWO PATIENTS THAT HAD A REACTION, HAD IT WITHIN A COUPLE OF MINUTES AFTER PUTTING THEIR LENSES IN. THE DOCTOR FLUSHED OUT THEIR EYES WITH SALINE AND THEIR EYES STARTED TO FEEL RELIEF WITHIN APPROXIMATELY TEN MINUTES. BY THE FOLLOWING DAY BOTH PATIENTS WERE FINE. NO OTHER TREATMENTS OR MEDICATIONS WERE GIVEN. DOCTOR ONLY SUGGESTED USING ARTIFICIAL TEARS, BUT DIDN'T PROVIDE THIS TO THE PATIENTS. AS EVENT INDICATES TWO (2) PATIENTS EXPERIENCED A REACTION TO THE PRODUCT, TWO MDRS WILL

  Patient problems: Burning Sensation; Irritation; Keratitis

  MAUDE report 6531275 ↗