UNFOLDER EMERALD EMERALDTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15050474500126), received between Feb 16, 2021 and Jul 13, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT AN OLD INSERTER BENT THE HAPTIC ARM AS THE LENS WAS GOING INTO THE EYE. THE OLD INSERTER SURGERY COMPLICATES THE SURGERY. THROUGH FOLLOW UP IT WAS LEARNED THAT THE TRAILING HAPTIC WAS BENT BY THE INSERTER ROD. THE SURGEON REPORTED THERE WAS NO PATIENT CONTACT, HOWEVER, ALSO REPORTED THE LENS WAS FULLY INSERTED AND ONLY THE CARTRIDGE TIP TOUCHED THE EYE. IT IS UNCLEAR IF THERE WAS PATIENT CONTACT OR THE EXTENT OF PATIENT CONTACT. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. AN INCISION ENLARGEMENT WAS NOT REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. THE PATIENT OUTCOME WAS REPORTED AS GOOD. IT WAS ALSO REPORTED THAT THE LOT NUMBER FOR THE INSERTER WAS NOT RECORDED ON THE DAY OF SURGERY AND IT IS IMPOSSIBLE TO KNOW WHICH LOT NUMBER WAS USED THE DAY OF THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322535 ↗
• MalfunctionApr 28, 2023Break; Scratched Material; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Break; Scratched Material; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE EMERALD INJECTOR BROKE THE HAPTICS, SCRATCHED AND TORE THE INTRAOCULAR LENS (IOL). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP LENS. REPORTEDLY, THE IOL WAS LIKELY DISCARDED. HOWEVER THE INJECTOR WILL BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829367 ↗
• MalfunctionOct 12, 2022Contamination; Contamination

  IT WAS REPORTED THAT SLIGHT STAIN HAD BEEN FOUND TO ATTACH ON THE UPPER SIDE OF THE INTRAOCULAR LENS (IOL) ZA9003, AFTER THE IOL WAS IMPLANTED. EXCHANGING THE LENS HAD NOT BEEN PLANNED BECAUSE THERE HAD BEEN NO HEALTH DAMAGE IN THE PATIENT AND THE CONDITION OF THE EYE HAD BEEN GOOD. IT WAS NOTED THAT THERE HAD BEEN NO STAIN AT THE OPTIC OF THE IOL WHEN THE IOL WAS SET. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO SUSPECT EMERALDT HANDPIECE. A SEPARATE REPORT WILL BE SUBMITTED FOR SUSPECT EMERALDC CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591671 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT THE SURGEON TRIED TO IMPLANT THREE (3) DIFFERENT 3-PIECE INTRAOCULAR LENSES (IOL) USING AN EMERALD INTRODUCER AND IN ALL CASES, HAPTICS KEPT BENDING WHEN INTRODUCING INTO THE CARTRIDGE TIP, PRIOR TO IMPLANTATION. THE SURGEON ASSUMES THE INTRODUCER TO BE BENT AND FAULTY. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/ APPLICATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE EVENT WHICH THE LENS REMAINS IN THE PATIENT'S EYE. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006197 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT THE SURGEON TRIED TO IMPLANT THREE (3) DIFFERENT 3-PIECE INTRAOCULAR LENSES (IOL) USING AN EMERALD INTRODUCER AND IN ALL CASES, HAPTICS KEPT BENDING WHEN INTRODUCING INTO THE CARTRIDGE TIP, PRIOR TO IMPLANTATION. THE SURGEON ASSUMES THE INTRODUCER TO BE BENT AND FAULTY. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/APPLICATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE EVENT WHICH THE LENS WHICH WAS PARTIALLY INSERTED IN THE PATIENT'S EYE. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006030 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT THE SURGEON TRIED TO IMPLANT THREE (3) DIFFERENT 3-PIECE INTRAOCULAR LENSES (IOL) USING AN EMERALD INTRODUCER AND IN ALL CASES, HAPTICS KEPT BENDING WHEN INTRODUCING INTO THE CARTRIDGE TIP, PRIOR TO IMPLANTATION. THE SURGEON ASSUMES THE INTRODUCER TO BE BENT AND FAULTY. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/ APPLICATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE EVENT WHICH THE LENS WAS FULLY INSERTED IN THE PATIENT'S EYE, THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12997418 ↗
• MalfunctionJul 24, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE INSERTER HANDPIECE PUNCTURED INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222552 ↗
• InjuryFeb 16, 2021Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO ROTATE THE KNOB OF THE INSERTER AS IT WAS STUCK, AND THAT THE FINGERS OF THE SURGEON SLIPPED CAUSING THE TIP OF THE CARTRIDGE TO TOUCH AND SCRATCH THE ENDOTHELIUM OF THE EYE. THE SURGEON REMOVED THE CARTRIDGE TIP FROM THE PATIENT'S EYE AND APPLIED A STRONG FORCE AND MANAGED TO ROTATE THE KNOB. THE LENS WAS IMPLANTED NORMALLY. THROUGH FOLLOW UP WE LEARNED THAT THE PATIENT SUFFERS FROM CORNEAL EDEMA CAUSED BY THE SCRATCH ON THE ENDOTHELIUM AND MEDICAL INTERVENTION WAS PRESCRIBED. AFTER TESTING THE INSERTER, IT WAS FOUND THAT THE EMERALD T INSERTER, HAD MORE RESISTANCE COMPARED WITH THE OTHER EMERALD T INSERTERS THAT THEY HAVE. NO FURTHER INFORMATION PROVIDED

  Patient problems: Corneal Edema

  MAUDE report 11335590 ↗