HEALON PRO 10240012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474636989), received between Jul 20, 2021 and Dec 1, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON NOTICED A SMALL GRAY SPEC FLOATING AROUND IN THE PATIENT'S EYE AFTER INJECTING AN OVD (OPHTHALMIC VISCOELASTIC DEVICE). THE SURGEON REMOVED THE SPEC AND PUT IN A CONTAINER FOR ANALYSIS UPON PRODUCT RETURN. THERE WERE NO COMPLICATIONS DURING SURGERY, WHICH WAS SUCCESSFUL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899142 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IT WAS LEARNED THAT FOR THIS EVENT, THE VISUAL SYMPTOMS ARE NOT DEBILITATING. THE PATIENT PRESENTED WITH HISTORY OF SIGNIFICANT PAIN, BLURRED VISION SINCE THE EVENING OF SURGERY, DIFFUSE CORNEAL EDEMA, ELEVATED INTRAOCULAR PRESSURE (IOP) TO 60 MMHG, MILD ANTERIOR SEGMENT INFLAMMATION, ORIGINALLY THOUGHT EDEMA SECONDARY TO ELEVATED IOP BUT WITH LOWERING OF IOP, LIMBAL TO LIMBAL EDEMA PERSISTED AND THEN CONSIDERED TO BE TASS TREATMENT PROVIDED WAS INTENSIVE TOPICAL STEROIDS AND IOP MEDS. THE FOLLOWING MEDS WERE ALSO GIVEN BUT WAS NOTED AS THE DOCTOR'S STANDARD CARE, PROLENSA EVERYDAY, INVELTYS 2X/DAY, MOXIFLOXACIN 2X/DAY, LUMIGAN , COMBIGAN 2X/DAY, SIMBRINZA 2X/DAY, DIAMOX 500 MG TABLETS. IT WAS STATED THAT CURRENT PATIENT STATUS IS THE IOP NORMAL, CORNEAL EDEMA RESOLVED, PUPIL REMAINS ENLARGED POSSIBLY RELATED TO ELEVATED IOP WITH IRIS ISCHEMIA AND OR SECONDARY TO POSSIBLE TASS, BEST CORRECTED VISUAL ACUITY (BCVA) 20/30. INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE OTHER PRODUCTS ARE NOT BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REC

  Patient problems: Blurred Vision; Corneal Edema; Eye Pain; Inflammation; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12205266 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IT WAS LEARNED THAT FOR THIS EVENT, THE VISUAL SYMPTOMS PRESENTED WITH SIGNIFICANT VISION LOSS, CORNEAL EDEMA RIGHT EYE AND ELEVATED INTRAOCULAR PRESSURE (IOP). TREATMENT PROVIDED WAS INTENSIVE TOPICAL STEROIDS, TOPICAL GLAUCOMA DROPS COSOPT 2X/DAY. THE FOLLOWING MEDS WERE ALSO GIVEN BUT WAS NOTED AS THE DOCTOR'S STANDARD CARE, DUREZOL EVERY 2 HRS. HOURS TAPERED TO 4 X DAY, COSOPT 2X/DAY, PROLENSA EVERYDAY , MOXIFLOXACIN 2X/DAY. IT WAS STATED THAT CURRENT PATIENT STATUS IS EDEMA AND INFLAMMATION RESOLVING, BEST CORRECTED VISUAL ACUITY (BCVA) 20/25 BUT EXPECTED TO CONTINUE TO IMPROVE. INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE OTHER PRODUCTS ARE NOT BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CUSTOMER INVESTIGATED THE CASES. HOWEVER, ROOT CAUSE FOR THE TASS HAS NOT BEEN DETERMINED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS 3 OF 6 CASES FOR TASS CAPTURING THE EVENT FOR THE HEALON PRO. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Corneal Edema; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 12200532 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IT WAS LEARNED THAT FOR THIS EVENT, THAT THERE WAS SIGNIFICANT VISION LOSS INITIALLY, AND LATER BECAME GOOD. TREATMENT PROVIDED WAS INTENSIVE TOPICAL STEROIDS. THE FOLLOWING MEDS WERE ALSO GIVEN BUT WAS NOTED AS THE DOCTOR'S STANDARD CARE, PROLENSA EVERYDAY, MOXIFLOXACIN 2X/DAY, DEXTENA INSERT. IT WAS STATED THAT CURRENT PATIENT STATUS IS IMPROVING NOW VISION AND DECREASING EDEMA. INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE OTHER PRODUCTS ARE NOT BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CUSTOMER INVESTIGATED THE CASES. HOWEVER, ROOT CAUSE FOR THE TASS HAS NOT BEEN DETERMINED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS 3 OF 6 CASES FOR TASS CAPTURING THE EVENT FOR THE HEALON PRO. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12200451 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IT WAS LEARNED THAT FOR THIS EVENT, THE VISUAL SYMPTOMS ARE NOT DEBILITATING. TREATMENT PROVIDED WAS INTENSIVE TOPICAL STEROIDS. THE FOLLOWING MEDS WERE ALSO GIVEN BUT WAS NOTED AS THE DOCTOR'S STANDARD CARE, PROLENSA EVERYDAY, INVELTYS 2X/DAY, MOXIFLOXICAN 2X/DAY, LATANOPROST EVERY HOUR, ADDED COMBIGAN 2X/DAY FOR INTRAOCULAR PRESSURE CONTROL. IT WAS STATED THAT CURRENT PATIENT STATUS IS THAT THE INFLAMMATION/CORNEAL EDEMA RESOLVED, BEST CORRECTED VISUAL ACUITY (BCVA) 20/20. INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE OTHER PRODUCTS ARE NOT BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CUSTOMER INVESTIGATED THE CASES. HOWEVER, ROOT CAUSE FOR THE TASS HAS NOT BEEN DETERMINED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 6 CASES FOR TASS CAPTURING THE EVENT FOR THE HEALON PRO. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12200352 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IT WAS LEARNED THAT FOR THIS SPECIFIC EVENT, THE VISUAL SYMPTOMS ARE NOT DEBILITATING. TREATMENT PROVIDED WAS INTENSIVE TOPICAL STEROIDS. THE FOLLOWING MEDS WERE ALSO GIVEN BUT WAS NOTED AS THE DOCTOR'S STANDARD CARE, PROLENSA EVERYDAY, INVELTYS 2X/DAY, MOXIFLOXICAN 2X/DAY. IT WAS STATED THAT CURRENT PATIENT STATUS IS THE EYE INFLAMMATION RESOLVED AND NOW GOOD VISION. INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE OTHER PRODUCTS ARE NOT BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CUSTOMER INVESTIGATED THE CASES. HOWEVER, ROOT CAUSE FOR THE TASS HAS NOT BEEN DETERMINED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 6 CASES FOR TASS CAPTURING THE EVENT FOR THE HEALON PRO. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12200270 ↗