HEALON GV 10294801Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00385445085417), received between Apr 21, 2017 and Apr 26, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE RESTRICTION CAUSED THE CANNULA TO POP OFF A UNIT OF HEALON GV AND THE VISCOELASTIC SQUIRTED OUT. THERE WAS NO PATIENT CONTACT OR INJURY NOTED, AND THE PROBLEM WAS NOT RELATED TO USE ERROR. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8553589 ↗
• MalfunctionAug 27, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT HEALON GV BOX WAS SEALED, BUT WHEN THE CUSTOMER OPENED IT TO GET THE HEALON PACKAGE THEY SAW THE PACKAGE WAS OPEN. THE PRODUCT WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT/CONTACT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7815561 ↗
• MalfunctionMay 4, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), SOME CRYSTALS WERE NOTICED IN THE HEALON VISCOELASTIC ONCE INJECTED INTO THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT WHEN THEY INSERTED THE LENS IN THE EYE, THEY NOTICED SOME CRYSTAL PARTICLES UNDER THE MICROSCOPE. NO ISSUES WERE REPORTED WITH THE IOL. REPORTEDLY, THE DOCTOR WAS ABLE TO VACUUM THE PARTICLES OUT. NO VISUAL ISSUES AND NO POST-OP INJURIES WERE REPORTED. THE PATIENT WAS REPORTED BEING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546140 ↗
• InjuryApr 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ENDOPHTHALMITIS POST PROCEDURE. HEALON GV WAS THE VISCOELASTIC USED. THE DATE OF SURGERY WAS (B)(6) 2017. AT DAY TWO (2) POST PROCEDURE THE PATIENT WAS SEEN IN THE PHYSICIAN¿S OFFICE AND WAS 20/20. ON FRIDAY(B)(6) 2017 THE PATIENT CALLED THE PHYSICIAN AND REPORTED A SEVERE INFECTION. THE EYE WAS INFLAMED, OOZING PUSS, SWOLLEN, AND HAD A PRESSURE OF 40. THE PHYSICIAN SENT THE PATIENT TO A RETINA SPECIALIST AND A VITRECTOMY WAS PERFORMED. THE PATIENT WAS GIVEN ANTIBIOTIC INJECTIONS. THE PATIENT HAD A RETINAL HEMORRHAGE. THE REPORTING PHYSICIAN NOTED THAT DURING THE PROCEDURE THE TECH FOLDED THE INTRAOCULAR LENS (IOL) WITH HER GLOVED FINGERS. THE IOL USED WAS A NON AMO LENS. THE HEALON GV PRODUCT WILL NOT BE RETURNED AS IT HAS ALREADY BEEN DISCARDED. FOLLOW UP WAS CONDUCTED TO OBTAIN THE CURRENT STATUS OF THE PATIENT HOWEVER PER THE CENTER CONTACT IT IS UNKNOWN. THE ONLY ADDITIONAL INFORMATION THE CONTACT PROVIDED WAS THE GENDER AND AGE OF THE PATIENT AND THAT HE WAS TREATED WITH IV ANTIBIOTICS.

  Patient problems: Inflammation; Intraocular Pressure Increased; Vitrectomy

  MAUDE report 6510169 ↗