TECNIS SIMPLICITY DCB00 (REF DCB0000280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474636248), received between Jun 30, 2023 and Dec 8, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT WHEN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE AND WHILE DOCTOR WAS ADJUSTING AND POSITIONING THE HAPTIC, THE HAPTIC BROKE. IOL WAS REMOVED AND REPLACED. SURGERY COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751111 ↗
• MalfunctionAug 22, 2025Crack; Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THE IOL WAS TRACKING ON THE SIDE OF THE TIP. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE BUT NO PATIENT INJURY WAS REPORTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO CONCERNS WERE RAISED REGARDING PATIENT OUTCOME. NO FURTHER INFORMATION AS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877833 ↗
• MalfunctionJan 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED WHEN IT WAS NOTICED THAT THE HAPTIC WAS CAUGHT IN THE INJECTOR AND BECAME DISLOCATED. THE IOL WAS REMOVED WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162023 ↗
• MalfunctionDec 21, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED BY THE SURGEON THAT THE LEADING HAPTIC OF THE INTRAOCULAR LENS DID NOT COME OUT OF THE PRELOADED CARTRIDGE CORRECTLY, AND WAS DEFECTIVE. LENS WAS PARTIALLY INSERTED IN THE PATIENTS LEFT EYE. A NEW LENS HAD TO BE OPENED AND IMPLANTED. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS A DELAY IN THE PROCEDURE. PATIENT OUTCOME WAS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372660 ↗
• MalfunctionNov 20, 2023Crack; Crack

  IT WAS REPORTED THE DCB00 MODEL INTRAOCULAR LENS (IOL) INSERTER CRACKED WHILE IN THE PATIENT'S OPERATIVE EYE. WHEN THE DOCTOR WENT TO IMPLANT THE IOL, HE SAW THAT THE TIP WAS STRESSED, LOOKED LIKE IT WAS GOING TO CRACK. THE DOCTOR STATED HE HAS SEEN THIS BEFORE, SO HE DECIDED TO NOT FULLY ADVANCE THE LENS AND USE A NEW ONE. HE FULLY THE ADVANCED THE DEFECTED INSERTER OUTSIDE THE PATIENTS EYE AND THE TIP CRACKED. THE DOCTOR DID THIS JUST TO CONFIRM WHAT HE THOUGHT WAS GOING TO HAPPEN. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179066 ↗
• MalfunctionJun 30, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) BROKE DURING THE IMPLANTATION. THE LENS CAME OUT WITH A BROKEN PROXIMAL HAPTIC FROM THE INJECTOR. THE IOL WAS REMOVED DURING THE SAME PROCEDURE. THROUGH FOLLOW UP WE LEARNED THAT A NON-JOHNSON AND JOHNSON LENS WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243873 ↗