TECNIS SIMPLICITY DCB00 (REF DCB0000245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05050474636170), received between Feb 18, 2021 and Sep 14, 2026 — classified as 6 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765251 ↗
• MalfunctionAug 11, 2026Ejection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202779 ↗
• MalfunctionJun 19, 2026Break

  IT WAS REPORTED THAT, FOLLOWING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE, A SMALL DEFECT WAS IDENTIFIED WITHIN THE LENS. THE DEFECT WAS LOCATED OUTSIDE THE PATIENT'S VISUAL AXIS AND WAS NOT ANTICIPATED TO ADVERSELY IMPACT CLINICAL OUTCOMES. IT WAS CONFIRMED THAT NO FORCE WAS APPLIED DURING LENS DELIVERY. NO PATIENT INJURIES, INCLUDING CAPSULAR TEAR OR OTHER COMPLICATIONS, WERE REPORTED, AND NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE DEVICE REMAINS IMPLANTED AND THE PATIENT OUTCOME WAS REPORTED AS FAVORABLE, WITH VISUAL ACUITY OF 20/30 AT POSTOPERATIVE WEEK 1, WITH MILD CORNEAL FOLDS NOTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563005 ↗
• MalfunctionApr 20, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAS BEEN IDENTIFIED AS DEFECTIVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933736 ↗
• MalfunctionDec 9, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764678 ↗
• MalfunctionNov 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE STIFF, AND THE HAPTICS WERE TAKING LONGER THAN USUAL TO UNFOLD IN THE EYE. THROUGH FOLLOW UP, WE LEARNED THAT ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED TO POSITION THE IOL IN THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600571 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAIL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22918222 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAIL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22918055 ↗
• MalfunctionAug 15, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED WITH THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THERE WAS A DEFECT IN THE INJECTOR TIP. THIS CAUSED THE LENS TO PROTRUDE FROM THE SIDE OF THE DEVICE AND RENDERING THEM UNUSABLE. DURING FOLLOW-UP, IT WAS CONFIRMED THAT THE MATERIAL CAME INTO CONTACT WITH THE PATIENT, BUT THE CUSTOMER WAS UNABLE TO REMOVE THE LENS FROM THE CARTRIDGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814932 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO A CAPSULE RUPTURE, THERE WAS AN INTRA-OPERATIVE CHANGE OF PROCEDURE INCLUDING VITRECTOMY. THERE WAS PATIENT CONTACT WITH THE PRELOADED INTRAOCULAR LENS (IOL) DEVICE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22294360 ↗
• MalfunctionMay 20, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH THAT APPEARED TO BE A MANUFACTURING ISSUE. THE IOL WAS INSERTED INTO THE PATIENT¿S EYE AND THEN REMOVED. THE IOL WAS REPLACED WITH ANOTHER ONE OF THE SAME DIOPTER. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058039 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS, A DEFECT WAS OBSERVED. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT EVENT DATE WAS NOT NOTED. THERE WAS NO REPORT OF PATIENT INJURY. THE PRODUCT WAS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039763 ↗
• MalfunctionApr 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A MISSING HAPTIC. THE ISSUE WAS NOTICED WHEN THE PACKAGING WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT WITH THE PRODUCT. A REPLACEMENT IOL WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766103 ↗
• MalfunctionMar 7, 2025Contamination; Contamination

  A DOCTOR REPORTED A COMPLAINT REGARDING MONOFOCAL INTRAOCULAR LENSES (IOLS) THAT EXHIBIT AN ISSUE AT THE TOP EDGE OF THE OPTIC. THAT THE MATERIAL APPEARS TO BE ADHERENT TO THE IOL OPTIC AND RESEMBLES CORTEX, BUT IT IS NOT A SCRATCH. WHILE IT CAN BE REMOVED WITH IRRIGATION ASPIRATION (IA), IT IS SOMETIMES DIFFICULT TO DO SO. THE DOCTOR MENTIONED THAT HE ENCOUNTERS THIS ISSUE IN APPROXIMATELY 1 OUT OF EVERY 50 TO 75 CASES, AND HE OBSERVED IT MORE FREQUENTLY LAST YEAR. THE DOCTOR INDICATED THAT THIS ISSUE IS NOT PREVENTING HIM TO IMPLANT THE LENS, ITS JUST THAT HE HAS TO GO THROUGH THE TROUBLE OF REMOVING THE MATERIAL OFF OF THE LENS. NO PATIENT COMPLICATIONS RELATED TO THIS ISSUE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT IS TWO (2) OUT THREE (3). TWO SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21552533 ↗
• MalfunctionDec 6, 2024Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE LEADING HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK IN THE INSERTER AND DAMAGED THE LENS. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861397 ↗
• MalfunctionNov 8, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED IN THE CONTAINER. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646601 ↗
• MalfunctionSep 25, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT TWO PRELOADED INTRAOCULAR LENSES (IOL) GOT STUCK IN THE INJECTOR AND WERE DAMAGED. THE NURSE HANDLING IT HAS LOADED HUNDREDS SUCCESSFULLY PREVIOUSLY. THE ISSUE HAPPENED DURING HANDLING AND PRIOR TO INSERTION. NO PATIENT INVOLVEMENT. THROUGH FOLLOW UP IT WAS LEARNT THAT ALCON BALANCED SALT SOLUTION (BSS) WAS USED A ROOM TEMPERATURE WITH NO ADDITIVES. BSS WAS INTRODUCED INTO THE INTO THE CARTRIDGE CANOPY. ONLY BSS INTRODUCED TO THE CARTRIDGE CANOPY, NO OPHTHALMIC VISCOSURGICAL DEVICE (OVD). THE AVERAGE DWELL TIME WAS APPROXIMATELY 1 MINUTE. IT WILL BE IN THE DWELL POSITION FOR 1 MINUTE WHICH IS SUFFICIENT, BASED ON PREVIOUS INVESTIGATIONS. SCRUB NURSE PUSHES THE INJECTOR AND THEN MAKE A TWIST TO ENGAGE THE LENS IN A DWELL POSITION. SCRUB NURSE PERFORMS THE INITIAL MOVEMENT OF THE LENS AND THE FIRST TWIST. ONCE THE LENS PASSED THE DWELL POSITION, IT WILL REMAIN UNINTERRUPTED. WHEN ADVANCING THE LENS ½ TWIST OR PERHAPS ¼ TWIST WILL BE DONE. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS AS ABOVE IOLS HAD NO PATIENT CONTACT. DCB00 BACK UP LENSES WERE USED. ALL CASES HAVE 2 IOLS OF THE SAME DIOPTER SENT AS PER STANDARD PROTOCOL. NO ISSUE WITH BACK UP LENSES AND SAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306263 ↗
• MalfunctionSep 24, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED RECENTLY DUE TO PATIENT EXPERIENCING PROGRESSIVE PAINLESS VISION LOSS OF BOTH EYES FOR 1 YEAR. THE PATIENT HAD POOR VISUAL ACUITY IN THE RIGHT EYE, AFFECTING THE QUALITY OF LIFE, AND MEDICAL TREATMENT WAS INEFFECTIVE, AND SURGICAL TREATMENT WAS PERFORMED. THE DOCTOR PRESCRIBED PHACOEMULSIFICATION AND CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION IN THE RIGHT EYE UNDER LOCAL ANESTHESIA. DURING THE CATARACT SURGERY REPORTEDLY, THE INJECTOR COULD NOT BE PUSHED, AND THE LENS WAS REMOVED FROM THE INJECTOR AND THE LENS HAPTIC WAS FOUND BROKEN. A REPLACEMENT LENS OF THE SAME MODEL WAS IMMEDIATELY USED TO COMPLETE THE SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292113 ↗
• MalfunctionJun 24, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK, HALF IN AND HALF OUT OF THE PATIENT'S LEFT EYE INCISION. THERE WAS PATIENT CONTACT. THE LENS WAS REMOVED. IT WAS ALSO REPORTED AS A HANDLING PROBLEM. A REPLACEMENT LENS WAS USED INSTEAD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602588 ↗
• MalfunctionJun 19, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REPORTED TO BE SCRATCHED. THE FINDING WAS OBSERVED UNDER THE MICROSCOPE PRIOR TO IMPLANTATION, WITHOUT CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571086 ↗
• MalfunctionMay 24, 2024Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Ejection Problem; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Ejection Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THE TRAILING HAPTIC WAS STUCK IN THE INJECTOR AND THERE WAS A STRUGGLE TO REMOVE THE IOL FROM THE INJECTOR. THE LENS HAD ALREADY OPENED IN THE EYE SO SURGEON HAD TO FINISH IMPLANTING. THE SURGEON HAD TO FORCEFULLY USE INSTRUMENTS TO DISLODGE THE HAPTIC AND REMOVE FROM THE INJECTOR. THE INJECTOR WAS DISCARDED. THROUGH FOLLOW UP, IT WAS REPORTED THAT IT COULD HAVE POTENTIALLY CAUSED HARM TO THE PATIENT DUE TO THE AMOUNT OF FORCE THE SURGEON HAD TO USE TO GET THE LENS OFF THE INJECTOR. EVERYTHING WENT FINE AFTERWARDS. THE PATIENT WAS DISCHARGED WITHOUT ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397828 ↗
• MalfunctionMay 22, 2024Contamination; Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A PIECE OF TISSUE/BLUE THREAD ON THE LENS AND THE PIECE WAS TAKEN OUT. THE LENS WAS FULLY INSERTED. THE PATIENT HAS FULLY RECOVERED. IT WAS REPORTED THERE WAS NO ISSUE WITH THE LENS ITSELF. THE PRODUCT IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378309 ↗
• MalfunctionApr 1, 2024Contamination; Contamination

  IT WAS REPORTED THAT A FIBROUS FOREIGN MATTER HAD ATTACHED TO THE TIP OF THE CARTRIDGE OF THE PRELOADED DCB00 INTRAOCULAR LENS (IOL). THE IOL WAS IMPLANTED, AND NO PATIENT INJURY OR HEALTH DAMAGE HAD DEVELOPED. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016015 ↗
• MalfunctionMar 21, 2024Crack; Crack

  IT WAS REPORTED THAT THERE WAS AN "ISSUE WITH THE CARTRIDGE TIP" OF A PRELOADED INTRAOCULAR LENS (IOL). THROUGH FOLLOW UP WE LEARNED THAT THE TIP OF THE CARTRIDGE "SPLIT" ON INSERTION INTO THE EYE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956542 ↗
• InjuryMar 15, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD AN UNFOLDING ISSUE WITH THE PATIENT'S RIGHT EYE. THE CUSTOMER REPORTED THAT THE TRAILING HAPTIC THAT WAS BADLY FOLDED. THE ISSUE WAS OBSERVED DURING THE SURGERY AND THERE WAS PATIENT CONTACT. THE EXTENT OF PATIENT CONTACT WAS NOT SPECIFIED. THE PROCEDURE WAS COMPLETED THE SAME DAY. THE SURGEON BELIEVES THAT THE CAUSE IS DUE TO THE INJECTOR. THE PRODUCT IS NOT AVAILABLE FOR RETURN. THROUGH FOLLOW UP IT WAS LEARNED THAT THE LENS WAS FULLY INSERTED. THE PATIENT HAD AN ANTERIOR VITRECTOMY PERFORMED. THE LENS WAS REMOVED AND REPLACED BY ANOTHER JOHNSON & JOHNSON LENS, MODEL AR40. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18918518 ↗