HEALON ENDOCOAT VT585URecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474547063), received between Sep 7, 2016 and Feb 6, 2025 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Contamination; Contamination

  THE CUSTOMER REPORTED SEEING A SMALL BLUE FIBER IN THE HEALON ENDOCOAT THAT WAS INJECTED FOR THE CASE. THE HEALON USED FOR THE CASE HAD BEEN DISPOSED OF IN THEIR SHARPS CONTAINER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327171 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS SEEING 2200 (20/200), HAD LOW VISIBILITY, AND INCREASED OCULAR PRESSURE IN THE OCULAR SINISTER (LEFT EYE). ACCOUNT STATED SHE FEELS THIS IS RELATED TO THE HEALON. SHE SAID HEALON OPERATED WELL, BUT ANOTHER PATIENT HAD THE SAME ISSUE AFTER IT WAS USED; THE DOCTOR DOES NOT WANT TO USE IT. NO SURGICAL INTERVENTION IS SCHEDULED, AS THEY FEEL THAT THE ISSUE WITH THE OCULAR PRESSURE WILL RESOLVE ITSELF WHEN THE BODY ABSORBS IT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT HAD CORNEA SWELLING AND INTEROCULAR PRESSURE. ALL NEGATIVE SYMPTOMS REPORTED, WENT AWAY. THE FOLLOW-UP VISIT SHOWED NO RESIDUAL SYMPTOMS AND THE PATIENT WAS SEEING GREAT RESULTS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES PATIENT #2, A SEPARATE REPORT WILL CAPTURE PATIENT #1.

  Patient problems: Blurred Vision; Corneal Edema; Intraocular Pressure Increased; Loss of Vision

  MAUDE report 12991179 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS SEEING 2200 (20/200), HAD LOW VISIBILITY, AND INCREASED OCULAR PRESSURE IN THE OCULAR SINISTER (LEFT EYE). ACCOUNT STATED SHE FEELS THIS IS RELATED TO THE HEALON. SHE SAID HEALON OPERATED WELL, BUT ANOTHER PATIENT HAD THE SAME ISSUE AFTER IT WAS USED; THE DOCTOR DOES NOT WANT TO USE IT. NO SURGICAL INTERVENTION IS SCHEDULED, AS THEY FEEL THAT THE ISSUE WITH THE OCULAR PRESSURE WILL RESOLVE ITSELF WHEN THE BODY ABSORBS IT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT HAD CORNEA SWELLING AND INTEROCULAR PRESSURE. THIS PATIENT HAD HERPES LESIONS THAT WERE UNRELATED TO THE PRODUCT; THEY EXISTED FROM BEFORE THE PROCEDURE. ALL NEGATIVE SYMPTOMS REPORTED, WENT AWAY. THE FOLLOW-UP VISIT SHOWED NO RESIDUAL SYMPTOMS AND THE PATIENT WAS SEEING GREAT RESULTS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES PATIENT #1, A SEPARATE REPORT WILL CAPTURE PATIENT #2.

  Patient problems: Blurred Vision; Corneal Edema; Intraocular Pressure Increased; Loss of Vision

  MAUDE report 12990310 ↗
• 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 12205012 ↗
• 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 4 OF 6 CASES FOR TASS CAPTURING THE EVENT FOR THE HEALON ENDOCOAT. 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 12200520 ↗
• 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 ENDOCOAT. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12200449 ↗
• 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 ENDOCOAT. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12200316 ↗
• 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 ENDOCOAT. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12200250 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT FROM A DOCTOR'S OFFICE WHICH INDICATED THREE OF THEIR PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THEY PROVIDED THE TWO LOT NUMBERS INVOLVED IN THE THREE CASES. HOWEVER, AT THE TIME OF THIS REPORT THEY DID NOT INDICATE WHICH LOT NUMBER CORRELATED WITH WHICH PATIENT. FOLLOW-UP WAS PERFORMED TO GET ADDITIONAL DETAILS. HOWEVER THE CUSTOMER ONLY PROVIDED THE DOCTORS NAMES AND INDICATED THAT DR. (B)(6) HAD TWO PATIENTS AND DR. (B)(6) HAD ONE PATIENT. DR. (B)(6) EVENT IS CAPTURED IN THIS MEDWATCH REPORT FOR ONE PATIENT WHICH WE WILL REFER TO AS PATIENT #2 FOR LOT 028719. AS DESCRIBED ABOVE, THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ALTHOUGH NOT SPECIFIED, IT¿S IMPORTANT TO NOTE THE REPORTED EVENT NORMALLY REQUIRES MEDICAL INTERVENTION TO RESOLVE. NO FURTHER INFORMATION WAS PROVIDED. THE OTHER COMPLAINTS ARE CAPTURED IN ANOTHER MDR REPORTS SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 11009052 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT FROM A DOCTOR'S OFFICE WHICH INDICATED THREE OF THEIR PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THEY PROVIDED THE TWO LOT NUMBERS INVOLVED IN THE THREE CASES. HOWEVER, AT THE TIME OF THIS REPORT THEY DID NOT INDICATE WHICH LOT NUMBER CORRELATED WITH WHICH PATIENT. FOLLOW-UP WAS PERFORMED TO GET ADDITIONAL DETAILS. HOWEVER THE CUSTOMER ONLY PROVIDED THE DOCTORS NAMES AND INDICATED THAT DR. (B)(6) HAD TWO PATIENTS AND DR. (B)(6) HAD ONE PATIENT. DR. (B)(6) EVENT IS CAPTURED IN THIS MEDWATCH REPORT FOR ONE PATIENT WHICH WE WILL REFER TO AS PATIENT #1 FOR LOT 028719. AS DESCRIBED ABOVE, THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ALTHOUGH NOT SPECIFIED, IT¿S IMPORTANT TO NOTE THE REPORTED EVENT NORMALLY REQUIRES MEDICAL INTERVENTION TO RESOLVE. NO FURTHER INFORMATION WAS PROVIDED. THE OTHER COMPLAINTS ARE CAPTURED IN ANOTHER MDR REPORTS SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 11009025 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT FROM A DOCTOR'S OFFICE WHICH INDICATED THREE OF THEIR PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THEY PROVIDED THE TWO LOT NUMBERS INVOLVED IN THE THREE CASES. HOWEVER, AT THE TIME OF THIS REPORT THEY DID NOT INDICATE WHICH LOT NUMBER CORRELATED WITH WHICH PATIENT. FOLLOW-UP WAS PERFORMED TO GET ADDITIONAL DETAILS. HOWEVER THE CUSTOMER ONLY PROVIDED THE DOCTORS NAMES AND INDICATED THAT DR. (B)(6) HAD TWO PATIENTS AND DR. (B)(6) HAD ONE PATIENT. DR. (B)(6) EVENT IS CAPTURED FOR THIS SUSPECT LOT NUMBER 028719 IN THIS MEDWATCH REPORT. AS DESCRIBED ABOVE, THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ALTHOUGH NOT SPECIFIED, IT¿S IMPORTANT TO NOTE THE REPORTED EVENT NORMALLY REQUIRES MEDICAL INTERVENTION TO RESOLVE. NO FURTHER INFORMATION WAS PROVIDED. ANOTHER MDR REPORT IS SUBMITTED FOR THE OTHER SUSPECT LOT NUMBER.

  Patient problems: Inflammation

  MAUDE report 11008951 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-SURGERY INVOLVING HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD), THE PATIENT HAD POSTOPERATIVE INFECTION IN THE LEFT EYE. THE SYMPTOMS WERE DESCRIBED AS GREASY SPOT IN VISION, LOTS OF FLOATERS, BLURRED VISION, REDNESS AND TEARING. THE PATIENT WAS PRESCRIBED OFLOXCIN, DUREZOL, ILEVERO AND ALPHAGAN MEDICATIONS. THE PATIENT WAS ALSO REFERRED TO A RETINAL SPECIALIST. REPORTEDLY, PATIENT'S EYE FEELS BETTER, AND CAN SEE A LITTLE BETTER. PATIENT¿S VISION WAS NOTED AS HAND MOTION ONLY. CUSTOMER INDICATED THAT THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Inflammation; Visual Disturbances

  MAUDE report 8547506 ↗
• MalfunctionNov 27, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A BLACK MONOFILAMENT HAIR/FIBER CAME OUT OF HEALON ENDOCOAT INTO THE PATIENT'S ANTERIOR CHAMBER (AC) AS ENDOCOAT WAS INJECTED AT THE BEGINNING OF THE CASE TO FILL THE AC. THE SYRINGE, ENDOCOAT, AND CANNULA WERE ALL NEW, STRAIGHT OUT OF THE STERILE J&J PACKAGING. THE BLACK FIBER CAME OUT AT THE END OF FILLING THE AC (INDICATING THAT THE BLACK FIBER HAD BEEN DEEP WITHIN THE ENDOCOAT IN THE SYRINGE, NOT AT THE TIP OF THE CANNULA). THE BLACK MONOFILAMENT FIBER WAS REMOVED FROM THE AC WITH INTRAOCULAR FORCEPS. IT WAS REPORTED PATIENT IS DOING FINE POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8109344 ↗
• MalfunctionNov 27, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A BLACK HAIR CAME OUT OF A VT585U HEALON ENDOCOAT INTO THE PATIENT'S ANTERIOR CHAMBER (RIGHT EYE). THE FOREIGN PARTICLE WAS SUCCESSFULLY REMOVED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8105318 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 PATIENTS EXPERIENCED CORNEAL EPITHELIAL DECOMPENSATION DURING SURGICAL CASES ON (B)(6) 2018, NECESSITATING DEBRIDEMENT OF CORNEAL EPITHELIUM ON 2 OUT OF THE 3 PATIENTS. REPORTEDLY, THE FIRST CASE WAS ACTUALLY ONLY A 45 MINUTE CASE ON A NON-DIABETIC PATIENT WITH A MACULAR HOLE. ALSO, THE PATIENTS EXPERIENCED CORNEAL ABRASIONS, BUT HAVE ALL HEALED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Abrasion; Corneal Decompensation; No Code Available

  MAUDE report 8087845 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR (4) PATIENTS EXPERIENCED CORNEAL EPITHELIAL DECOMPENSATION IN ASSOCIATION WITH THE USE OF HEALON ENDOCOAT (VT585U). REPORTEDLY, THE PATIENTS HAD CORNEAL ABRASION BUT ALL HAVE HEALED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Abrasion; No Code Available

  MAUDE report 8087796 ↗
• MalfunctionMar 20, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHEN CUSTOMER OPENED THE BOX OF VT585U HEALON ENDOCOAT, THE PEEL PACK WAS ALREADY UNPEELED. NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7356484 ↗
• InjuryFeb 20, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SHADOWY/BLOB WAS NOTICED INTO THE PATIENT'S EYE WHILE INJECTING THE VISCOELASTIC ENDOCOAT. REPORTEDLY, IT COULD NOT BE ASPIRATED OUT WITH THE I/A (IRRIGATION/ASPIRATION) OR THE PHACO HANDPIECE. IT WOULD REPEL WHATEVER TOUCHED IT AND IT WAS VERY STICKY. THEY ENDED UP LEAVING IT IN THE EYE AND IT DISSOLVED AFTER A FEW DAYS. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED EPINEPHRINE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE INCISION WAS ENLARGED. A CAPSULAR TENSION RING WAS IMPLANTED TOGETHER WITH A SYMFONY ZXR00 +22.0 DIOPTER. TO DATE THE LENS REMAINS IMPLANTED. NO VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7284776 ↗
• InjuryJan 18, 2018Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available; Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DOCTOR NOTICED A ''BUBBLE'' MATERIAL THAT REPELLED THE PHACO IMMEDIATELY AFTER INJECTING HEALON ENDOCOAT MODEL VT585U. ALSO, THE DOCTOR SAW SHADOWING, DEBRIS, AND 2 AIR BUBBLES COMING OUT OF THE HEALON. REPORTEDLY, THE DOCTOR ATTEMPTED TO ASPIRATE WITHOUT ANY SUCCESS. THE DOCTOR ALSO FELT THAT THIS EVENT WEAKENED THE POSTERIOR CAPSULE, SO A SULCUS LENS WAS IMPLANTED INSTEAD. THE MATERIAL ALMOST COMPLETELY COVERED THE PUPILLARY FIELD, BUT ONCE THE LENS WAS IMPLANTED, IT MOVED BEHIND THE IRIS. AT THE PATIENT'S ONE WEEK POST-OPERATIVE VISIT WITH THE DOCTOR ON (B)(6) 2017, THE 2 AIR BUBBLES WERE NO LONGER VISIBLE AND THE PATIENT WAS PRESCRIBED COMBIGAN EYE DROPS AS A PROPHYLACTIC MEASURE. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING OKAY POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204551 ↗
• MalfunctionJun 21, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PIECE OF FIBER WAS NOTICED WHILE INJECTING VISCOELASTIC HEALON INTO THE PATIENT'S EYE. REPORTEDLY, THE FIBER WAS REMOVED FROM THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6658991 ↗
• InjuryNov 21, 2016Break; Break

  IT WAS REPORTED THAT PART OF THE HEALON ENDOCOAT SYRINGE DISLODGED. WHEN DOCTOR WAS INJECTING HEALON ENDOCOAT INSIDE THE EYE, THE REMOVABLE WHITE FULCRUM PIECE CAME LOOSE RESULTING IN THE SUDDEN AND FORCEFUL MOVEMENT OF THE DEVICE TOWARDS THE EYE WHILE THE CANNULA WAS ALREADY INSERTED INSIDE THE EYE. NOTHING ON THE DEVICE BROKE LOOSE OTHER THAN THE WHITE FULCRUM PIECE. WHEN WITHDRAWN, IT TORE ANTERIOR CAPSULE CAUSING DOCTOR TO HAVE TO CHANGE HIS LENS SELECTION TO A 3 PIECE LENS. THE DOCTOR BELIEVES THAT THE REMOVABLE WHITE FULCRUM PIECE WAS INDEED SNAPPED FIRMLY IN PLACE UPON USE IN THIS CASE AND CAME DISLODGED ONLY DURING USE BY THE DOCTOR WHILE INSIDE THE EYE. REPORTEDLY, THERE WAS NO VISIBLE DAMAGE OR CRACKS ON THE WHITE FINGER GRIP; ORIENTATION OF THE FINGER GRIP IN RELATION TO THE INJECTION HAND WHILE IN USE IS UNKNOWN. INCISION ENLARGEMENT WAS REQUIRED. PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6119287 ↗
• MalfunctionSep 7, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING SURGERY THE CANNULA OF THE VISCOELASTIC HEALON ENDOCOAT, SPIT OUT A FEW METAL FRAGMENTS INTO THE ANTERIOR CHAMBER OF THE PATIENT'S EYE. THE SURGEON WAS ABLE TO REMOVE THEM VIA IRRIGATION/ASPIRATION (I&A) PROCEDURE. THE PATIENT WAS REPORTED BEING FINE POST OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5934974 ↗