HEALON5 PRO 10240015Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474636996), received between Mar 20, 2020 and May 2, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE DOCTOR WAS USING THE COHESIVE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) TO FORM THE ANTERIOR CHAMBER (AC) ON A PATIENT POST GLAUCOMA SHUNT. AFTER EXPRESSING A SIGNIFICANT AMOUNT OUTSIDE THE EYE, THE DOCTOR PUT SOME TEMPORALLY TO FORM THE AC FOLLOWED BY NASALLY. AS THE DOCTOR WAS INJECTING NASALLY, A MINUTE WHITE PARTICLE CAME OUT WITH THE HEALON. IT WAS FREE FLOATING IN THE ANTERIOR CHAMBER NASALLY. THE DOCTOR DEPRESSED THE WOUND TO EXPRESS IT OUT OF THE EYE BUT WAS UNABLE TO DO IT WITHOUT FLATTENING THE AC. THE DOCTOR WAS UNABLE TO SUCK IT OUT WITH THE SYRINGE. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PATIENT REQUIRED A SECONDARY EYE SURGERY FOR SOMETHING UNRELATED TO THIS EVENT, WHICH ALLOWED THE DOCTOR TO REMOVE THE PARTICLE FROM THE LEFT EYE. THERE WAS NO PATIENT INJURY AND NO PLANNED INTERVENTIONS. THE PATIENT IS DOING WELL. THE PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14260367 ↗
• InjuryAug 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A PATIENT EXPERIENCED CAPSULAR ENTRAPMENT SYNDROME, EXPERIENCING SOME LEVEL OF 2-3 DIOPTER SHIFTS FOLLOWING CATARACT SURGERY, REQUIRING AN IMMEDIATE POST-OPERATIVE YTTRIUM-ALUMINUM-GARNET (YAG) LASER PROCEDURE FOR CORRECTION. ISSUE WAS A RESULT OF RESIDUAL HEALON 5 PRO OPHTHALMIC VISCOSURGICAL DEVICE (OVD) REMAINING IN THE EYE, POTENTIALLY POSTERIOR TO THE INTRAOCULAR LENS (IOL), FOLLOWING SURGERY, EVEN AFTER WHAT THE SURGEON DESCRIBES AS METICULOUS IRRIGATION ASPIRATION (IA) REMOVAL. THE PATIENT IS DOING FINE, AND PROGRESSING NICELY ACCORDING TO THE SURGEON, AND HE HAS MADE THE CLINICAL DECISION TO RETURN TO USAGE OF THE HEALON DUET PRO OVD PRODUCT AS A SOLUTION. PRODUCT WAS DISCARDED AND IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10365671 ↗
• InjuryAug 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A PATIENT EXPERIENCED CAPSULAR ENTRAPMENT SYNDROME, EXPERIENCING SOME LEVEL OF 2-3 DIOPTER SHIFTS FOLLOWING CATARACT SURGERY, REQUIRING AN IMMEDIATE POST-OPERATIVE YAG LASER FOR CORRECTION. ISSUE WAS A RESULT OF RESIDUAL HEALON 5 PRO OVD REMAINING IN THE EYE, POTENTIALLY POSTERIOR TO THE IOL, FOLLOWING SURGERY, EVEN AFTER WHAT THE SURGEON DESCRIBES AS METICULOUS IA REMOVAL. THE PATIENT IS DOING FINE, AND PROGRESSING NICELY ACCORDING TO THE SURGEON, AND HE HAS MADE THE CLINICAL DECISION TO RETURN TO USAGE OF THE HEALON DUET PRO OVD PRODUCT AS A SOLUTION. PRODUCT WAS DISCARDED AND IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10364834 ↗
• InjuryAug 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT EXPERIENCED CAPSULAR ENTRAPMENT SYNDROME, EXPERIENCING SOME LEVEL OF 2-3 DIOPTER SHIFTS FOLLOWING CATARACT SURGERY, REQUIRING AN IMMEDIATE POST-OPERATIVE YTTRIUM ALUMINUM GARNET (YAG) LASER FOR CORRECTION. ISSUE WAS A RESULT OF RESIDUAL HEALON 5 PRO OVD REMAINING IN THE EYE, POTENTIALLY POSTERIOR TO THE IOL, FOLLOWING SURGERY, EVEN AFTER WHAT THE SURGEON DESCRIBES AS METICULOUS IRRIGATION/ ASPIRATION (IA) REMOVAL. THE PATIENT IS DOING FINE, AND PROGRESSING NICELY ACCORDING TO THE SURGEON, AND HE HAS MADE THE CLINICAL DECISION TO RETURN TO USAGE OF THE HEALON DUET PRO OVD PRODUCT AS A SOLUTION. PRODUCT WAS DISCARDED AND IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10364776 ↗
• InjuryJul 8, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT THE HEALON PRODUCT COAGULATED IN THE LEFT EYE OF A PATIENT AND THEY COULD NOT GET IT OUT. THE DOCTOR HAD TO USE INTERIOR VITRECTOR TO REMOVE THE MATERIAL FROM THE EYE. EVEN WITH HIGH VACUUM IT OCCLUDED THE HANDPIECE. THEY HAD TO MAKE AN ENLARGED INCISION AND USE SUTURES ON THE PATIENT. THE DOCTOR THINKS THAT HE TOOK CARE OF THE ISSUE AND NO SURGICAL OR MEDICAL INTERVENTIONS ARE REQUIRED IN THE FUTURE. IT WAS INDICATED THAT THE PATIENT SEEMED TO BE FINE AND THERE WAS NO APPARENT ADVERSE AFFECTS. THE PATIENT WAS SENT HOME DIRECTEDLY AFTER THE SURGERY. THE ACCOUNT REPORTED THE SYRINGE WAS THROWN AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10248308 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEALON 5 PRO WAS USED IN TWO PATIENTS WHO EXPERIENCED PRESSURE SPIKES OF 45 AT SAME DAY POSTOP. IT WAS INDICATED THAT THE OPERATIVE EYE IS THE RIGHT EYE (OD). THAT THE INTRAOCULAR PRESSURE (IOP) IMPROVED FIVE DAYS POST-OP. THE PATIENT WAS ADVISED TO USE PRESERVATIVE FREE ARTIFICIAL TEARS AND TO CONTINUES TAKING PREDNISONE, OFLOXACIN AND KETOROLAC TWICE A DAY. CUSTOMER ALSO REPORTED THAT THE PATIENT IS DOING FINE AS THE PRESSURE WENT DOWN POST-OP. NO FURTHER INFORMATION IS AVAILABLE. THIS EMDR REPORT CAPTURES PATIENT #2. A SEPARATE EMDR REPORT IS BEING SUBMITTED FOR THE PATIENT #1.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 9860973 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER USED HEALON 5 PRO IN TWO PATIENTS THAT EXPERIENCED PRESSURE SPIKES OF 45 AT SAME DAY POSTOP. THRU FOLLOW-UP IT WAS REPORTED THAT THE OPERATIVE EYE IS THE RIGHT EYE. PATIENT WAS TAKING DAIMOX BUT DISCONTINUED TAKING IT AS THE PRESSURE IMPROVED FIVE DAYS POST-OP. PATIENT CONTINUES TO TAKE PREDNISONE AND KETOROLAC AND OFLOXAIN TWICE A DAY. CUSTOMER ALSO REPORTED THAT THE PATIENT IS DOING FINE AS THE PRESSURE WENT DOWN POST-OP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES PATIENT #1. A SEPARATE MEDWATCH IS BEING SUBMITTED FOR PATIENT #2.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 9858668 ↗