HEALON DUET 10290080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474573574), received between Jan 10, 2017 and Apr 14, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Mechanical Problem; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  THE DOCTOR REPORTED AN ISSUE WITH A NEW CANNULA, NOTING DIFFICULTY IN PASSING IT THROUGH A 1-MILLIMETER SIDE PORT INCISION DUE TO ITS LARGER SIZE COMPARED TO THE PREVIOUS VERSION AND AN UNPOLISHED SURFACE THAT CAUSED IT TO CATCH DURING USE. HE OBSERVED THAT IN TWO INSTANCES, THE CANNULA RELEASED OR POPPED THROUGH THE INCISION, WITH ONE OCCURRENCE INVOLVING CONTACT WITH THE CAPSULAR BAG; HOWEVER, THIS DID NOT RESULT IN ANY COMPLICATIONS. ALL CASES WERE COMPLETED AND NO PRODUCT TO RETURN. THE DOCTOR STATED THAT WHILE THE ISSUE WAS NOT CRITICAL FOR HIM PERSONALLY, IT MIGHT POSE CHALLENGES FOR HIS COLLEAGUES AND INQUIRED ABOUT THE AVAILABILITY OF SMOOTHER CANNULAS IF NECESSARY. HE ALSO TESTED THE HEALON PRO CANNULA, WHICH FUNCTIONED BUT REQUIRED ADDITIONAL FORCE AND SEPARATED INTO LAYERS DURING USE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880288 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THE NEEDLE STARTED SMOKING INSIDE THE PATIENT'S EYE, WHICH CAUSED THE IRIS TO FLUFF AND LED TO A CORNEAL BURN. CUSTOMER NOTED THAT SHE DID NOT HEAR THE BEEP THAT USUALLY SIGNALS A RISE IN TEMPERATURE. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT REQUIRED EXTENSIVE SUTURING AT THE END OF THE CASE TO ACHIEVE WOUND CLOSURE. SUTURES WERE REMOVED. PATIENT RESULTED WITH A CORNEAL SCAR, ASTIGMATISM BUT CORRECTABLE TO 20/20. NO ADDITIONAL SURGERY REQUIRED. PHACO SETTINGS: VACUUM LOW: 200, HIGH: 350, POWER: 40%. WHITESTAR ON YES. MODE & SUBSETTINGS DESIGNATIONS, PERISTALTIC, CONTINUOUS, 8/4, 67%, 83PPS. BOTTLE HEIGHT: 100 IN/CM. INCISION SIZE: 2.4MM. DOCTOR'S PHACO TECHNIQUE: DIVIDE & CONCUR. MODEL & SERIAL NUMBER OF EQUIPMENT: CONSOLE: SIGNATURE PRO, SERIAL NUMBER: (B)(6) (INCORRECT NUMBER), HANDPIECE: ELLIPS FX, SN# NOT AVAILABLE. TUBING TYPE: OPO73, TIP: 21G BLUE. VISCOELASTIC: DUET. THIS REPORT IS FOR HEALON DUET. OTHER REPORTS WERE SUBMITTED FOR WHITESTAR, PHACO HANDPIECE, PHACO TIP, PHACO TUBING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Clouding/Hazing; Eye Burn; Eye Injury; Visual Impairment

  MAUDE report 21883702 ↗
• InjuryApr 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE DOCTOR ''HAD A ABOUT 3 PATIENTS WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) ON (B)(6) 2018. IT WAS LATER CONFIRMED THAT AT LEAST 1 PATIENT WAS AFFECTED. IN ADDITION, THE DOCTOR BELIEVES THE HEALON DUET MAY NOT HAVE CAUSED OR CONTRIBUTED TO THE TASS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7431538 ↗
• MalfunctionJan 10, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK THREAD WAS FOUND IN THE PATIENT'S EYE COMING FROM THE VISCOELASTIC HEALON ENDOCOAT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 6239598 ↗