HEALON DUET PRO 10240016Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474651425), received between Oct 8, 2019 and Feb 19, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Contamination” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  THREE (03) HEALON DUET PRO BOXES IN WHICH THE SYRINGES WERE PUT WERE SIGNIFICANTLY DAMAGED. THE EXTERNAL SHIPPING BOX WAS COMPLETELY INTACT WITH NO SIGNS OF DAMAGE AND THE ACTUAL DUET SYRINGES ARE FINE. IN ADDITION, THEY WERE SHORTED 5 UNITS (35 RECEIVED) ALTHOUGH THE PACKING SLIP STATES 40 WERE SHIPPED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413230 ↗
• MalfunctionOct 9, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE HEALON PRO OVD CONTAINED A THREAD-LIKE PARTICLE AFTER BEING INJECTED INTO A PATIENT¿S EYE. THE SURGEON SUCCESSFULLY REMOVED IT USING THE PHACO HANDPIECE AND NO COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION SUGGESTS THAT THE FOREIGN PARTICLE MAY HAVE BEEN PRESENT IN THE HEALON OR COULD HAVE RESULTED FROM CONTAMINATION PRIOR TO DELIVERY INTO THE EYE. IT IS POSSIBLE THAT THE HAIR ORIGINATED FROM SOMETHING IN THE STERILE TRAY SETUP. PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409304 ↗
• MalfunctionOct 11, 2022Contamination; Contamination

  IT WAS REPORTED DURING SURGERY THE DOCTOR INJECTED THE HEALON BEFORE INTRAOCULAR LENS (IOL) INSERTION AND NOTICED A SMALL GRAY PARTICLE APPEAR IN THE PATIENT'S OPERATIVE EYE AFTER DISCHARGING THE HEALON. THE ACCOUNT INDICATED IT IS POSSIBLE THAT THE PARTICLE CAME OUT OF THE HEALON SYRINGE. THE GRAY PARTICLE WAS REMOVED DURING IRRIGATION/ASPIRATION (I/A) AND THE SURGERY WAS SUCCESSFUL. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE WAS NO MEDICAL INTERVENTION AND O SURGICAL INTERVENTION. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS STABLE, NO COMPLICATIONS. BOTH THE GRAY PARTICLE AND THE HEALON ARE NOT AVAILABLE FOR RETURN AS BOTH WERE DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578203 ↗
• MalfunctionMay 23, 2022Mechanical Problem; Operating System Becomes Nonfunctional; Mechanical Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE THREADS AT THE END OF THE SYRINGE OF THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) DID NOT LOCK AND WAS JUST SHOOTING OUT AT THE END OF THE SYRINGE. A BRIEF DESCRIPTION OF THE ISSUE INDICATED THAT THE CANNULA WAS NOT GETTING DISCONNECTED BUT WOULD NOT CONNECT AT ALL. IT WOULD SPIN, THERE WAS SOMETHING WRONG WITH THE THREADS ON THE SYRINGE. THE CANNULA COULD NOT BE TIGHTENED ONTO THE SYRINGE. THERE WAS PATIENT CONTACT; HOWEVER, THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SECOND DEVICE REPORTED. ANOTHER REPORT IS BEING FILED FOR THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478982 ↗
• MalfunctionMay 23, 2022Mechanical Problem; Operating System Becomes Nonfunctional; Mechanical Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE THREADS AT THE END OF THE SYRINGE OF THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) DID NOT LOCK AND WAS JUST SHOOTING OUT AT THE END OF THE SYRINGE. A BRIEF DESCRIPTION OF THE ISSUE INDICATED THAT THE CANNULA WAS NOT GETTING DISCONNECTED BUT WOULD NOT CONNECT AT ALL. IT WOULD SPIN, THERE WAS SOMETHING WRONG WITH THE THREADS ON THE SYRINGE. THE CANNULA COULD NOT BE TIGHTENED ONTO THE SYRINGE. THERE WAS PATIENT CONTACT. HOWEVER; THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE FIRST DEVICE REPORTED. ANOTHER REPORT IS BEING FILED FOR THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478815 ↗
• MalfunctionApr 15, 2022Contamination; Contamination

  IT IS REPORTED THAT AFTER INJECTION OF THE HEALON5 PRO A SMALL PARTICLE OF PLASTIC WAS OBSERVED IN THE PATIENT'S LEFT EYE. ISSUE WAS NOTIFIED DURING IMPLANTATION OR APPLICATION. IT WAS REMOVED AND THERE WAS NO DELAY IN PROCEDURE REPORTED. NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. IT WAS NOTED THAT PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. PATIENT IS FULLY RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14123818 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGERY CENTER REPORTED THE PRODUCT DID NOT BEHAVE AS USUAL (PERFORMANCE WAS NOT SPECIFIED) AND BECAUSE OF THAT THEY SUSPECT THE PRODUCT CAME FROM AN OUTSIDE VENDOR AND HAD BEEN STORED OUTSIDE THROUGHOUT THE NIGHT. IT WAS INDICATED THAT THE PRODUCT LOOKED NORMAL, HOWEVER FOLLOWING CATARACT EXTRACTION PROCEDURES TWO PATIENTS SUFFERED EYE INFECTIONS RESULTING IN BLINDNESS. THE CUSTOMER NOTED THAT THEY ARE NOT BLAMING THE PRODUCT, OR JOHNSON & JOHNSON AND THAT THEY ARE ONLY TRYING TO RULE OUT THE VARIABLES FOR THESE CASES WHERE THE VISCOELASTIC PRODUCT USED MAY HAVE PREVIOUSLY BEEN FROZEN AND BROUGHT BACK TO ROOM TEMPERATURE PRIOR TO USE. THE CUSTOMER STATED HE COULD NOT CONFIRM KNOWLEDGE IF THE ITEM HAD IN FACT BEEN FROZEN BUT DID INDICATE THE SURGEON PERFORMING THE SURGERIES STATED HE FELT THE ITEM WAS NOT PERFORMING AS EXPECTED (PERFORMANCE WAS NOT SPECIFIED). NO PATIENT INFORMATION COULD BE PROVIDED. IT WAS NOTED THAT THE SURGERIES TOOK PLACE IN THE MONTH OF (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Infections; Loss of Vision

  MAUDE report 11611509 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGERY CENTER REPORTED THE PRODUCT DID NOT BEHAVE AS USUAL (PERFORMANCE WAS NOT SPECIFIED) AND BECAUSE OF THAT THEY SUSPECT THE PRODUCT CAME FROM AN OUTSIDE VENDOR AND HAD BEEN STORED OUTSIDE THROUGHOUT THE NIGHT. IT WAS INDICATED THAT THE PRODUCT LOOKED NORMAL, HOWEVER FOLLOWING CATARACT EXTRACTION PROCEDURES TWO PATIENTS SUFFERED EYE INFECTIONS RESULTING IN BLINDNESS. THE CUSTOMER NOTED THAT THEY ARE NOT BLAMING THE PRODUCT, OR JOHNSON & JOHNSON AND THAT THEY ARE ONLY TRYING TO RULE OUT THE VARIABLES FOR THESE CASES WHERE THE VISCOELASTIC PRODUCT USED MAY HAVE PREVIOUSLY BEEN FROZEN AND BROUGHT BACK TO ROOM TEMPERATURE PRIOR TO USE. THE CUSTOMER STATED HE COULD NOT CONFIRM KNOWLEDGE IF THE ITEM HAD IN FACT BEEN FROZEN BUT DID INDICATE THE SURGEON PERFORMING THE SURGERIES STATED HE FELT THE ITEM WAS NOT PERFORMING AS EXPECTED (PERFORMANCE WAS NOT SPECIFIED). NO PATIENT INFORMATION COULD BE PROVIDED. IT WAS NOTED THAT THE SURGERIES TOOK PLACE IN THE MONTH OF (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Infections; Loss of Vision

  MAUDE report 11611428 ↗
• MalfunctionOct 8, 2019Contamination; Contamination

  IT WAS REPORTED THAT A SURGEON OBSERVED ''WHITE FIBER'' WHEN INJECTING HEALON DUET PRO OPHTHALMIC VISCOSURGICAL DEVICE (OVD). THE WHITE FIBER WAS REMOVED BY IRRIGATION AND ASPIRATION. THERE WAS NO PATIENT ADVERSE EVENT REPORTED BY THE SURGEON. THROUGH FOLLOW-UP IT WAS CLARIFIED THAT THE DOCTOR DID NOT OBSERVE THE WHITE FIBER INSIDE OF THE OVD. HOWEVER, WHEN THE DOCTOR INJECTED THE VISCO DEVICE, HE OBSERVED THE WHITE FIBER IN THE PATIENT'S EYE. HENCE, THE DOCTOR CONCLUDED THAT THE WHITE FIBER MAY HAVE COME FROM THE HEALON DUET PRO. DOCTOR WAS ABLE TO REMOVE THE WHITE FIBER BY IRRIGATION AND ASPIRATION. THE PATIENT WAS FINE POST-OP, SURGERY WENT WELL. IT WAS NOTED THERE WILL BE NO PRODUCT RETURNED, AND NO DEBRIS AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9169893 ↗