HEALON GV PRO 10240014Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474651654), received between Oct 24, 2019 and Dec 1, 2022 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Contamination” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED TORN ZONULES WITH AN OVD (OPHTHALMIC VISCOELASTIC DEVICE) AND HAD TO HAVE A VITRECTOMY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Zonular Dehiscence

  MAUDE report 15897651 ↗
• MalfunctionAug 31, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHITE SPECKS WERE NOTICED IN THE EYE WHILE USING THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD). ALL WHITE SPECKS WERE SUCCESSFULLY REMOVED FROM THE EYE WITH IRRIGATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332675 ↗
• MalfunctionAug 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHITE SPECKS WERE NOTICED IN THE EYE. THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS ALLOWED TO ACCLIMATIZE FULLY TO OPERATING ROOM TEMPERATURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143146 ↗
• MalfunctionAug 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHITE SPECKS WERE NOTICED IN THE LEFT EYE OF A PATIENT. THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS ALLOWED TO ACCLIMATIZE FULLY TO OPERATING ROOM TEMPERATURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143127 ↗
• MalfunctionAug 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHITE SPECKS WERE NOTICED IN THE EYE. THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS ALLOWED TO ACCLIMATIZE FULLY TO OPERATING ROOM TEMPERATURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142675 ↗
• MalfunctionJul 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT A CUSTOMER USED HEALON GV PRO AND NOTICED WHITE SPECS IN THE PATIENT'S EYE. THE WHITE SPECS SEEMED TO COME OUT DURING IRRIGATION/ASPIRATION (I/A). THE LENS WAS IMPLANTED FINE. AS OF NOW, NO KNOWN VISUAL ISSUES. NO KNOWN PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888062 ↗
• MalfunctionJul 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT A CUSTOMER USED HEALON GV PRO AND NOTICED WHITE SPECS IN THE PATIENT'S EYE. THE WHITE SPECS SEEMED TO COME OUT DURING IRRIGATION/ASPIRATION (I/A). THE LENS WAS IMPLANTED FINE. AS OF NOW, NO KNOWN VISUAL ISSUES. NO KNOWN PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887780 ↗
• MalfunctionJul 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT A CUSTOMER USED HEALON GV PRO AND NOTICED WHITE SPECS IN THE PATIENT'S EYE. THE WHITE SPECS SEEMED TO COME OUT DURING IRRIGATION/ASPIRATION (I/A). THE LENS WAS IMPLANTED FINE. AS OF NOW, NO KNOWN VISUAL ISSUES. NO KNOWN PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887540 ↗
• MalfunctionJul 14, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED CANNULAS ARE COMING EITHER COMPLETELY CLOGGED OR PARTIALLY CLOGGED AND WE ARE NOT ABLE TO ADVANCE THE VISCOELASTIC DURING PRIMING OR DURING PROCEDURES. M.D. HAS A HARD TIME FILLING THE EYE BECAUSE OF THE PARTIAL CLOG. THEY HAVE DISPOSED OF THE CANNULAS. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164450 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED OF A CORNEAL BURN EVENT. THE NUCLEAR MATERIAL WAS REMOVED WITH THE WHITESTAR SYSTEM, THAT A SMALL CORNEAL BURN WAS NOTED DURING EARLY GROOVING AT THE MAIN INCISION. IT WAS INDICATED THAT THE PHACO POWER WAS VERY LOW AND THAT THE CATARACT WAS NOT A DIFFICULT CATARACT; HOWEVER, THE CUSTOMER HAD DIFFICULTIES USING THE HEALON GV PRO AND THE PHACO HANDPIECE WOULD GET CLOGGED. IT WAS NOTED THAT AT THE END OF THAT DAY, DURING CLEANING OF THE HANDPIECE/TIP THERE WERE DRIED RESIDUAL HEALON ON TOP OF THE HANDPICE TIP. REPORTEDLY, THERE WAS NO CORNEAL BURN AT THE DAY ONE (1), THE EYE WAS CLEAR AND THE PATIENT OUTCOME WAS REPORTED TO BE GOOD. THERE WAS NO LOSS OF BEST-CORRECTED VISUAL ACUITY (BCVA) AND NO INCREASE IN THE INTRAOCULAR PRESSURE (IOP). THE ACCOUNT NOTED THAT THE HEALON GV PRO PRODUCT WHICH WAS ON THE LISTED RECALL LIST WAS USED FOR THIS SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Burn

  MAUDE report 9556359 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED ENDOPHTHALMITIS POST-SURGERY WHERE HEALON GV PRO WAS USED. THE REPORTER INDICATED THAT THEY DO NOT HAVE ANY REASON TO BELIEVE THAT THE CAUSE WAS JOHNSON & JOHNSON (J&J) PRODUCT RELATED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR HEALON GV PRO. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH J&J DEVICE USED IN THIS CASE.

  Patient problems: Endophthalmitis

  MAUDE report 9254189 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED ENDOPHTHALMITIS POST-SURGERY WHERE HEALON GV PRO WAS USED. THE REPORTER INDICATED THAT THEY DO NOT HAVE ANY REASON TO BELIEVE THAT THE CAUSE WAS JOHNSON & JOHNSON (J&J) PRODUCT RELATED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR HEALON GV PRO. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH J&J DEVICE USED IN THIS CASE.

  Patient problems: Endophthalmitis

  MAUDE report 9254115 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEALON GV PRO WAS USED ON A PATIENT WHO EXPERIENCED ENDOPHTHALMITIS. THE REPORTER STATED THAT THEY DO NOT FEEL THE CAUSE WAS JOHNSON AND JOHNSON RELATED. AS ENDOPHTHALMITIS IS NOT SELF-RESOLVING THEN MEDICATION IS EXPECTED TO HAVE BEEN ADMINISTERED. THEREFORE, THIS EVENT HAS BEEN ASSESSED AS REPORTABLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Endophthalmitis; No Code Available

  MAUDE report 9242447 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEALON GV PRO WAS USED ON A PATIENT WHO EXPERIENCED ENDOPHTHALMITIS. THE REPORTER STATED THAT THEY DO NOT FEEL THE CAUSE WAS JOHNSON AND JOHNSON RELATED. AS ENDOPHTHALMITIS IS NOT SELF-RESOLVING THEN MEDICATION IS EXPECTED TO HAVE BEEN ADMINISTERED. THEREFORE, THIS EVENT HAS BEEN ASSESSED AS REPORTABLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Endophthalmitis; No Code Available

  MAUDE report 9242427 ↗
• InjuryOct 24, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE HEALON GV PRO WAS USED IN THE PATIENT¿S OPERATIVE EYE. DURING IOL INSERTION, DOCTOR FOUND THAT THE OVD WAS DIFFICULT TO REMOVE/DIFFICULT TO USE. THE PATIENT EXPERIENCED INTRAOCULAR PRESSURE (IOP). DURING THE SAME PROCEDURE, SURGICAL INTERVENTION WAS REQUIRED AS THE DOCTOR CUT AN INCISION TO RELEASE AQUEOUS AND GV. MEDICATIONS WERE PRESCRIBED. THE PATIENT WAS SEEN THE NEXT MORNING. THEIR IOP WAS NORMAL. THE CUSTOMER EXPLAINED VIA FOLLOW-UP, REGARDING THIS PATIENT, SHE WAS PRESCRIBED MOXIFLOXACIN INTRAOPERATIVELY. AFTER DECOMPRESSING THE ANTERIOR CHAMBER THE PATIENT WAS GIVEN DIAMOX AND COMBIGAN. THEN PATIENT WAS STARTED ON MOXIFLOXACIN AND PREDNISOLONE EVERY TWO HOURS UNTIL BEDTIME. THE FOLLOWING DAY THE MOXIFLOXACIN AND PREDNISOLONE WERE CHANGED TO 4 TIMES A DAY. HER IOP WAS 14 THE FOLLOWING MORNING. INITIALLY, IT WAS ALSO REPORTED THAT SOME OF HIS PATIENTS EXPERIENCED IOP POSTOPERATIVE. A SEPARATE FILE # (B)(4), WAS OPENED TO CAPTURE THE REST OF THE PATIENTS. MDR# ? NO MORE INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9231320 ↗