UNFOLDER EMERALDRecalls & reported problems across all models

We found 2 models of UNFOLDER EMERALD by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 258 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2016 and Jan 6, 2026 — classified as 29 injuries, 229 malfunctions.

The most frequently reported specific device problem is “Crack” (76 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported UNFOLDER EMERALD problems

UNFOLDER EMERALD models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• UNFOLDER EMERALD EMERALDC

  LENS, GUIDE, INTRAOCULAR
  250 reports
• UNFOLDER EMERALD EMERALDT

  LENS, GUIDE, INTRAOCULAR
  8 reports

Recent UNFOLDER EMERALD adverse event reports

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

• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD ITS HAPTIC BENT DUE TO LENS INJECTOR MALFUNCTIONING. CONSEQUENTLY, THE LENS WAS ONLY PARTIALLY INSERTED. HOWEVER, IT WAS ALSO REPORTED THAT THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. A REPLACEMENT AR40E 23.0 DIOPTER LENS WITH SERIAL NUMBER (B)(6) WAS SUCCESSFULLY IMPLANTED USING A NEW INJECTOR WITHOUT COMPLICATIONS. THE PROCEDURE WAS DELAYED BY APPROXIMATELY TWO MINUTES. THE DIRECTIONS FOR USE WERE FOLLOWED, AND NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY OCCURRED. DETAILS REGARDING PATIENT OUTCOME AND STATUS REMAINS UNKNOWN. NO ADDITIONAL INFORMATION ABOUT THE COMPLAINT IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986085 ↗
• MalfunctionMar 27, 2025Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP WAS NOT EVEN. IT LOOKED LIKE IT WAS MELTED. ACCOUNT INDICATED THAT THE TIP WAS IN CONTACT WITH THE PATIENT. THE SURGEON WAS ABLE TO IMPLANT THE LENS WITH THE DAMAGED CARTRIDGE AND THERE WERE NO PROBLEMS WITH THE PATIENT AFTERWARDS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715637 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT THE CARTRIDGE WAS DAMAGED WHICH CAUSED DAMAGE TO THE LENS. THE LENS WAS REMOVED AND REPLACED. THE PRODUCT WAS DISCARDED UPON COMPLETING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627514 ↗
• MalfunctionMar 17, 2025Crack; Crack

  IT WAS REPORTED THAT WHEN THE TIP OF THE CARTRIDGE WAS VIEWED UNDER THE MICROSCOPE, IT PRESENTED GROOVES (SHARP BURRS ALONG THE EDGE). DURING THE PROCEDURE, IT WAS NECESSARY TO MAKE AN INCISION LARGER THAN USUAL IN THE PATIENT'S EYE. THE MATERIAL WAS DISCARDED UPON COMPLETING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21627312 ↗
• InjuryFeb 7, 2025Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) PRESENTED A HAPTIC DAMAGED UPON LENS IMPLANTATION IN THE PATIENT'S RIGHT EYE. PRE-OPERATIVE VISUAL ACUITY WAS 30 CM. THE INSTRUCTIONS FOR USE WERE FOLLOWED. ACCOUNT INDICATED THAT THE LENS WAS PARTIALLY INSERTED IN THE PATIENT'S EYE. THE INCISION WAS ENLARGED, AND THE PATIENT UNDERWENT A VITRECTOMY. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW-UP, WE LEARNED THAT THE CARTRIDGE TIP WAS NOT DAMAGED AND THERE WAS NO RESISTANCE WHEN HANDLING THE CARTRIDGE. NO ADDITIONAL SURGICAL INTERVENTION IS PLANNED. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT (MFR REPORT 3012236936-2025-0000238) WILL BE SUBMITTED FOR THE LENS MENTIONED ABOVE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21339861 ↗
• MalfunctionJan 31, 2025Contamination; Contamination

  IT WAS FOUND THERE WAS FOREIGN MATERIAL DURING INTRAOCULAR LENS IMPLANTATION. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285654 ↗
• MalfunctionJan 10, 2025Break; Break

  PATIENT GENDER: FEMALE. THE NON PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) WAS DAMAGED DURING LOADING, TECHNICIAN ERROR WAS REPORTED AND ISSUE RELATED TO USE ERROR WAS CONFIRMED. THE EMERALD CARTRIDGE WAS THE ISSUE THAT CAUSED THE TECHNICIAN TO LOAD THE IOL INCORRECTLY HOWEVER, THE SPECIFIC CARTRIDGE ISSUE WAS NOT PROVIDED. THERE WAS PATIENT CONTACT HOWEVER, NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION WAS PERFORMED DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131995 ↗
• MalfunctionDec 31, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS DETACHED INSIDE THE INJECTOR DURING IMPLANTATION. THE INJECTOR WAS DEFECTIVE AND THE LENS WAS IN CONTACT WITH THE PATIENT'S EYE. THROUGH FOLLOW-UP, WE LEARNED, THAT THE PATIENT IS WELL. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS WITH THE SAME DIOPTER. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A SEPARATE REPORT WILL BE SUBMITTED UNDER THE NUMBER 3012236936-2024-0003488 TO CAPTURE THE INTRAOCULAR LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048627 ↗
• MalfunctionOct 10, 2024Crack; Device Difficult to Setup or Prepare; Crack; Device Difficult to Setup or Prepare

  PROBLEMS WITH THE LAST BATCH OF THE EMERALD CARTRIDGES WERE REPORTED BY THE DOCTOR. THEY SEEM TO HAVE BECOME NARROWER AND THE DOCTOR IS HAVING DIFFICULTY IMPLANTING THE LENSES, THEY ARE USING THE CARTRIDGES WITH THE EMERALD INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE LENS WAS INSERTED, THERE WAS NO INJURY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE NEW BATCH THAT CAME IN WE USED WITHOUT HAVING THIS PROBLEM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20414070 ↗
• MalfunctionOct 9, 2024Crack; Device Difficult to Setup or Prepare; Crack; Device Difficult to Setup or Prepare

  PROBLEMS WITH THE LAST BATCH OF THE EMERALD CARTRIDGES WERE REPORTED BY THE DOCTOR. THEY SEEM TO HAVE BECOME NARROWER AND THE DOCTOR IS HAVING DIFFICULTY IMPLANTING THE LENSES, THEY ARE USING THE CARTRIDGES WITH THE EMERALD INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE LENS WAS INSERTED, NO INJURY TO PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ONLY PROBLEM WITH THE EMERALD CARTRIDGE, THE LENS IS TOO TIGHT AT THE TIP, REQUIRING A LOT OF FORCE ON THE INJECTOR THREAD. CARTRIDGE BEVEL IS FRAYED. THE FACILITY ALSO REPORTS THERE IS STILL ANOTHER CLOSED BOX OF THE CARTRIDGE MODEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413961 ↗
• InjurySep 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN USING AN INJECTOR TO IMPLANT A MONOFOCAL INTRAOCULAR LENS (IOL) INTO A PATIENT¿S RIGHT EYE, THE HAPTIC WAS AMPUTATED BY THE INJECTOR. THE IOL WAS REMOVED WITH PACMAN TECHNIQUE. THEY USED ANOTHER LENS OF THE SAME DIOPTER WITH THE SAME CARTRIDGE TO COMPLETE THE SURGERY. A CORNEAL INCISION ENLARGEMENT WAS MADE WITH MANUAL IMPLANTATION OF 3-PIECE SENSAR LOI. EXTERNALIZATION OF HAPTICS VIA NEEDLES MADE, FLANGE CONNECTION WITH BATTERY-OPERATED CAUTERY. SUPERIOR CORNEAL SUTURE (4 STITCHES) MADE. BALANCE SALT SOLUTION (BSS) WAS USED FOR HYDRATION OF THE DEVICE. IT WAS CONFIRMED THAT THE TIP OF THE CARTRIDGE WAS NOT DAMAGED AND THAT THE ISSUE WAS NOT DUE TO MISUSE. IT WAS NOTED THAT THE PATIENT IS WELL. THE LENS AND CARTRIDGE ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED DURING THE SURGERY BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 20116290 ↗
• MalfunctionAug 14, 2024Crack; Crack

  IT WAS REPORTED THAT THE UNKNOWN NON-PRELOADED INTRAOCULAR LENS (IOL) HAD MARKS ON SURFACE AFTER IMPLANTATION. IOL HAD TO BE REMOVED DURING THE SAME PROCEDURE. THE CARTRIDGE WAS SPLITTING ON PARTS WHERE IT FOLDED TOGETHER. THERE WAS INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR THE CARTRIDGE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE INTRAOCULAR LENS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19988287 ↗
• InjuryJul 15, 2024Mechanical Jam; Ejection Problem; Mechanical Jam; Ejection Problem

  IT WAS REPORTED THE NON PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) WAS STUCK IN THE EMERALDC30 CARTRIDGE. ALTHOUGH THE EXTENT OF PATIENT CONTACT IS UNKNOWN, CONTACT DID OCCUR. AN UNPLANNED VITRECTOMY WAS PERFORMED HOWEVER, THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19743382 ↗
• InjuryJul 6, 2024Crack; Crack

  IT WAS REPORTED THAT AN UNFOLDER EMERALD CARTRIDGE HAS A BUMP IN THE PLASTIC AND CUTTING THE PATIENT'S OPERATIVE EYE. THE UNEVEN CARTRIDGE TIP WAS CUTTING THE PATIENT, THE TIP IS UNEVEN AND NOT SMOOTH. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE THE STANDARD OF CARE REQUIRED. THE PRODUCT WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury

  MAUDE report 19685210 ↗
• MalfunctionJun 21, 2024Crack; Ejection Problem; Crack; Ejection Problem

  IT WAS REPORTED THAT DURING THE INSERTION THE SURGEON NOTICED A BUMP ON THE PLASTIC OF AN EMERALD CARTRIDGE. IT WAS REPORTED IT WAS NOT A SMOOTH INSERTION, DESPITE SURGEON EXTENDING THE INCISION IN THE PATIENT'S OPERATIVE EYE. THE PRODUCT BOX WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19590196 ↗

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