HEALON 5 10290051Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00385445083215), received between Oct 28, 2016 and Jul 10, 2017 — classified as 20 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGERY SITE HAD A CASE OF MILD TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN THE LEFT (OS) OF THE PATIENT. ON (B)(6) 2016, DURING THE 1-DAY POSTOPERATIVE VISIT FOR THE SECOND EYE (OS), THE ANTERIOR FINDINGS HAD WORSENED COMPARED TO THE 6-HOUR POST-OPERATIVE STUDY VISIT. THE DOCTOR DETERMINED THAT THE ANTERIOR FINDINGS ALONG WITH THE SUBJECTIVE COMPLAINTS WERE SEVERE ENOUGH TO REQUIRE MEDICAL INTERVENTION AND THE STEROID DOSING WAS INCREASED FROM WHAT THE STUDY PROTOCOL SPECIFIED. CONSERVATIVELY, THE ADVERSE EVENT WAS CATEGORIZED AS MILD ANTERIOR SEGMENT SYNDROME (TASS). THE EVENT WAS RESOLVED ON (B)(6) 2016 WITHOUT SEQUELAE. THE CAUSE OF THE TASS IS THOUGHT TO BE RELATED TO AN ISSUE WITH THE STERILIZATION OF THE SURGICAL INSTRUMENTS. THE DOCTOR REPORTS TWO EVENTS OF TASS ON THE SAME DAY. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH CASE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6697997 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGERY SITE HAD A CASE OF MILD TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN THE PATIENT'S LEFT EYE (OS). ON (B)(6) 2016, DURING THE 1-DAY POSTOPERATIVE VISIT FOR THE SECOND EYE (OS), THE ANTERIOR FINDINGS HAD WORSENED COMPARED TO THE 6-HOUR POST-OPERATIVE STUDY VISIT. THE INVESTIGATOR DETERMINED THAT THE ANTERIOR FINDINGS ALONG WITH THE SUBJECTIVE COMPLAINTS WERE SEVERE ENOUGH TO REQUIRE MEDICAL INTERVENTION AND THE STEROID DOSING WAS INCREASED FROM WHAT THE STUDY PROTOCOL SPECIFIED. CONSERVATIVELY, THE ADVERSE EVENT WAS CATEGORIZED AS MILD ANTERIOR SEGMENT SYNDROME (TASS). THE EVENT RESOLVED ON (B)(6) 2016 WITHOUT SEQUELAE. THE CAUSE OF THE TASS IS THOUGHT TO BE RELATED TO AN ISSUE WITH THE STERILIZATION OF THE SURGICAL INSTRUMENTS. THE DOCTOR REPORTS TWO EVENTS OF TASS ON THE SAME DAY. A SEPARATE REPORT IS BEING FILED ON EACH EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6695652 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, DURING THE 6-HOUR POSTOPERATIVE VISIT, THE INTRAOCULAR PRESSURE (IOP) WAS 37 MMHG. THE RIGHT EYE (OD) WAS TREATED WITH AN IOP REDUCING MEDICATION. THE SUBJECT RETURNED FOR A VISIT ON (B)(6) 2016. THE INTRAOCULAR PRESSURE WAS 15 MMHG. THE ADVERSE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695640 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CATARACT SURGERY OS (LEFT EYE) (B)(6) 2017. FOLLOWING CATARACT SURGERY DURING THE 1-DAY POST OP, ON (B)(6) 2017, THE PATIENT HAD AN IOP (INTRAOCULAR PRESSURE) SPIKE OF 35 MMHG. THE EYE WAS TREATED WITH AN IOP REDUCING MEDICATION AND THE PATIENT RETURNED ON (B)(6) 2017, WHERE THE IOP HAD REDUCED TO 16MMHG, AT WHICH TIME THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE PATIENT HAD RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695594 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CATARACT SURGERY ON THE RIGHT EYE (OD) ON (B)(6) 2016. FOLLOWING CATARACT SURGERY DURING THE 1-DAY POST OP, THE SUBJECT HAD AN INTRAOCULAR PRESSURE (IOP) SPIKE OF 29MMHG. THE EYE WAS TREATED WITH AN IOP REDUCING MEDICATION AND THE PATIENT RETURNED ON (B)(6) 2016, WHERE THE IOP HAD REDUCED TO 09MMHG. THE PATIENT HAS NOW RECOVERED AND THE EVENT IS CONSIDERED RESOLVED WITHOUT SEQUELAE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695581 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A CATARACT PATIENT EXPERIENCED A SPIKE IN INTRAOCULAR PRESSURE (IOP) WITH THE VISCOELASTIC MODEL/BRAND HEALON 5 ON THE RIGHT (OD) OPERATIVE EYE. A DESCRIPTION OF THE EVENT FROM THE SURGERY CENTER INDICATED ON (B)(6) 2016, DURING A 6 HOUR POST-OPERATIVE VISIT, THE IOP WAS AT 30MMHG. THE OD WAS TREATED WITH AN IOP REDUCING MEDICATION. ON (B)(6) 2016, THE IOP PRESSURE HAD REDUCED TO 23MMHG. THE PATIENT OUTCOME WAS THAT THE PATIENT HAD RECOVERED AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695536 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED FROM A CLINICAL STUDY THAT A CATARACT PATIENT EXPERIENCED A SPIKE IN INTRAOCULAR PRESSURE (IOP) WITH THE VISCOELASTIC MODEL/BRAND HEALON 5 ON THE LEFT (OS) OPERATIVE EYE. A DESCRIPTION OF THE EVENT FROM THE SURGERY CENTER INDICATED THE PATIENT HAD UNDERGONE CATARACT SURGERY ON (B)(6) 2017 AND FOLLOWING THE CATARACT SURGERY DURING THE 4-8 HOUR POST OP EXAM, THE IOP HAD ROSE TO 32MMHG. THE OS WAS TREATED WITH AN IOP REDUCING MEDICATION. AT A ONE DAY POST OP EXAM, THE IOP PRESSURE HAD REDUCED TO 18MMHG. THE PATIENT RECOVERED AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695465 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, DURING THE 1-DAY POSTOPERATIVE VISIT FOR THE FIRST EYE (OD) RIGHT EYE, THE INTRAOCULAR PRESSURE (IOP) WAS 44MMHG. OD WAS TREATED WITH A WOUND BURP AND AN IOP-REDUCING MEDICATION. THE PATIENT RETURNED FOR AN UNSCHEDULED VISIT ON (B)(6) 2016, AND THE INTRAOCULAR PRESSURE (OD) WAS 14MMHG. THE ADVERSE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE PATIENT RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695411 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERY OS, (LEFT EYE) THE PATIENT RETURNED FOR THE 6-HOUR POSTOPERATIVE VISIT. THE INTRAOCULAR PRESSURE (IOP) WAS 38 MMHG. OS WAS TREATED WITH AN IOP-REDUCING MEDICATION. THE PATIENT RETURNED FOR THE 1-DAY POSTOPERATIVE VISIT ON (B)(6) 2016, AND THE INTRAOCULAR PRESSURE OS WAS 11 MMHG. THE ADVERSE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE PATIENT RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695368 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, DURING THE 6-HOUR POSTOPERATIVE VISIT, THE INTRAOCULAR PRESSURE (IOP) WAS 43 MMHG. THE DOCTOR PERFORMED AN AC TAP (ANTERIOR CHAMBER). THE LEFT EYE (OS) WAS TREATED WITH AN IOP REDUCING MEDICATION. THE PATIENT WAS SEEN ON (B)(6) 2016, AND THE INTRAOCULAR PRESSURE OS WAS 12 MMHG. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE PATIENT RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695328 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, DURING THE 1-DAY POSTOPERATIVE VISIT, THE INTRAOCULAR PRESSURE (IOP) WAS 31 MMHG. THE LEFT EYE (OS) WAS TREATED WITH AN IOP REDUCING MEDICATION. THE PATIENT RETURNED FOR THE UNSCHEDULED POSTOPERATIVE VISIT ON (B)(6) 2016. THE INTRAOCULAR PRESSURE OS WAS 20 MMHG. THE ADVERSE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE AND THE IOP REDUCING MEDICATION WAS DISCONTINUED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695307 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, DURING THE 6-HOUR POSTOPERATIVE VISIT FOR THE FIRST EYE (OS) LEFT EYE, THE INTRAOCULAR PRESSURE (IOP) WAS 30 MMHG. THE DOCTOR PERFORMED AN AC TAP (ANTERIOR CHAMBER). THE PATIENT WAS SEEN ON (B)(6) 2016, AND THE IOP WAS 18 MMHG. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT CONTINUED WITH THE PROTOCOL-SPECIFIC MEDICATION REGIMEN. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695305 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, DURING THE 1-DAY POSTOPERATIVE VISIT FOR THE SECOND EYE (OS) LEFT EYE, THE INTRAOCULAR PRESSURE (IOP) WAS 29 MMHG. THE PATIENT WAS TREATED WITH IOP-REDUCING MEDICATION. AT THE 1-WEEK POSTOPERATIVE VISIT ON (B)(6) 2016, THE IOP HAD REDUCED TO 16 MMHG. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT CONTINUED WITH THE PROTOCOL-SPECIFIED MEDICATION REGIMEN. THE PATIENT HAS NOW RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695282 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERY, THE PATIENT RETURNED FOR THE 6-HOUR POSTOPERATIVE VISIT. THE INTRAOCULAR PRESSURE (IOP) LEFT EYE (OS) WAS 36MMHG. THE LEFT EYE WAS TREATED WITH IOP REDUCING MEDIATION. THE PATIENT RETURNED FOR THE 1-DAY POSTOPERATIVE VISIT ON (B)(6) 2016. THE INTRAOCULAR PRESSURE OS WAS 10MMHG. THE ADVERSE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE AND THE IOP-REDUCING MEDICATION WAS DISCONTINUED. PATIENT RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695250 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, DURING THE 1-DAY POSTOPERATIVE VISIT FOR THE FIRST EYE (OD), RIGHT EYE, THE INTRAOCULAR PRESSURE (IOP) WAS 28 MMHG. THE PATIENT WAS TREATED WITH AN IOP-REDUCING MEDICATION. AT THE 1-WEEK POSTOPERATIVE VISIT ON (B)(6) 2016, THE IOP HAD DECREASED TO 13 MMHG. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT CONTINUED WITH THE PROTOCOL-SPECIFIED MEDICATION REGIMEN. THE PATIENT HAS NOW RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695228 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERY ON (B)(6) 2016, THE PATIENT RETURNED FOR THE 6-HOUR POSTOPERATIVE VISIT OS (LEFT EYE). THE INTRAOCULAR PRESSURE (IOP) OS WAS 34 MMHG. OS WAS TREATED WITH AN IOP-REDUCING MEDICATION. THE PATIENT RETURNED FOR THE 1-DAY POSTOPERATIVE VISIT ON (B)(6) 2016, AND THE IOP WAS 18 MMHG. THE ADVERSE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE, AND THE IOP REDUCING MEDICATION WAS DISCONTINUED. THE PATIENT RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695196 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CATARACT SURGERY ON THE LEFT EYE (OS) ON (B)(6) 2016. FOLLOWING CATARACT SURGERY DURING THE 6 HOUR POST OP, THE SUBJECT HAD AN IOP OF 36MMHG. THE EYE WAS TREATED WITH AN IOP REDUCING MEDICATION AND A PARACENTASIS. THE PATIENT RETURNED ON (B)(6) 2016, WHERE THE IOP HAD REDUCED TO 19MMHG, AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE IOP REDUCING MEDICATION WAS DISCONTINUED. PATIENT NOW RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6695157 ↗
• InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING CATARACT SURGERY, THE SUBJECT HAD INCREASED INTRAOCULAR PRESSURE (IOP) OF 38 MMHG (MILLIMETER OF MERCURY) IN THE RIGHT EYE. THE EYE WAS TREATED WITH AN IOP REDUCING MEDICATION AND THE SUBJECT RETURNED ON (B)(6)2016 FOR THE 1-DAY POST-OP APPOINTMENT, WHERE THE IOP HAD REDUCED TO 16 MMHG AT WHICH TIME THE SERIOUS ADVERSE EVENT (SAE) WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE ADVERSE EVENT WAS CONSIDERED RESOLVED AND THE IOP MEDICATION WAS DISCONTINUED. THE SUSPECT PRODUCT WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6688783 ↗
• InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST-OP ((B)(6) 2016), THE INTRAOCULAR PRESSURE (IOP) IN THE RIGHT EYE (OD - OCULUS DEXTER) OF THE (B)(6) YEAR-OLD MALE PATIENT, WAS 35 MMHG (MILLIMETER OF MERCURY). REPORTEDLY, THE OD WAS TREATED WITH AN IOP REDUCING MEDICATION AND THE PATIENT WAS INSTRUCTED TO CONTINUE THE MEDICATION (ONE DROP TWICE A DAY). THE PATIENT WAS SEEN AGAIN BY THE DOCTOR ON (B)(6) 2016, AND THE IOP WAS 15 MMHG. THE ADVERSE EVENT WAS CONSIDERED RESOLVED AND THE IOP MEDICATION WAS DISCONTINUED. THE SUSPECT PRODUCT WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6688781 ↗
• InjuryOct 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A ZCT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE AND REPLACED WITH A ZCT150 225 DIOPTER IOL. AFTER THE LENS EXCHANGE, THE PHYSICIAN REPORTED THAT A PATIENT HAD INFLAMMATORY REACTION ONE DAY POST-OP; ALLEGEDLY DUE TO HEALON5. THE PHYSICIAN WAS ABLE TO CALM THE INFLAMMATION BY USING TOPICAL STEROIDS (PREDNISOLONE/TERAZOL). THERE WERE 20 OTHER SURGERIES THAT DAY AND THIS WAS THE ONLY PATIENT THAT USED HEALON5 ON (B)(6) 2016 AND HAD INFLAMMATION ISSUES. NO OTHER PATIENTS HAD AN INFLAMMATORY REACTION. THIS PATIENT HAS LENS IMPLANTED IN THE RIGHT EYE AS WELL BUT THERE WAS NO PROBLEM WITH THE RIGHT EYE. THE PATIENT IS NOT ALLERGIC TO ANYTHING AND IS HEALTHY. PATIENT'S CONDITION IMPROVED DRAMATICALLY WITH STEROID EYE DROPS USED TOPICALLY. PATIENT IS STILL ON STEROID AND ON A TAPERING SCHEDULE AT THIS TIME UNTIL TAPER IS ENDED. ON (B)(6) 2016 THE PHYSICIAN DETERMINED THAT THE PATIENT SHOWED SIGNS OF IMPROVEMENT. PATIENT'S VISUAL ACUITY IS 20/25 +2. THIS REPORT WILL CAPTURE THE HEALON THAT WAS USED ON (B)(6) 2016. THE ZCT150 LENS EXPLANTED ON THIS DAY WILL BE CAPTURED ON A SEPARATE MDR.

  Patient problems: Inflammation

  MAUDE report 6064264 ↗