TECNIS SIMPLICITY DCB00 (REF DCB0000170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474636026), received between Jun 4, 2021 and Sep 25, 2026 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a preloaded monofocal intraocular lens (IOL) was implanted and subsequently explanted and replaced with a 3-piece intraocular lens (IOL) (model AR40E, 15.5 diopter). The reason for the explant and replacement was not reported. Patient outcome information was unavailable. No further information was provided.

  Patient problems: Eye Injury

  MAUDE report 50899688 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831501 ↗
• MalfunctionJun 23, 2026Ejection Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD AN EARLY DEPLOYMENT OF THE LENS AND HAPTICS IN A PSEUDOEXFOLIATION PATIENT, AND DUE TO ALREADY POOR ZONULES, THE SURGEON DID NOT WANT THE LENS FORCED INTO THE BAG. THE LENS WAS CUT IN THE EYE, REMOVED, AND A NEW LENS WAS INJECTED INTO THE BAG WITHOUT COMPLICATIONS. NO PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER ALSO REPORTED THAT THE HAPTIC WAS STUCK TO HAPTIC AND HAPTIC WAS STUCK TO OPTIC. BOTH THE LENS AND INJECTOR WERE DISPOSED OF. THROUGH FOLLOW UP, THE OR (OPERATING ROOM) TEAM WAS NOT SURE ABOUT THE HAPTIC ISSUE, THEREFORE, THEY REPORTED BOTH HAPTIC STUCK TO HAPTIC OR WAS THE HAPTIC WAS STUCK TO OPTIC MAY HAVE OCCURRED IN THE PATIENT'S LEFT EYE. THERE WERE NO UNPLANNED SUTURES, UNPLANNED VITRECTOMY, OR UNPLANNED INCISION ENLARGEMENT REQUIRED WHEN REMOVING THE IOL. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602717 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, A DEFINED CUT WAS OBSERVED ON THE PERIPHERAL OPTIC NEAR THE TRAILING OPTIC¿HAPTIC JUNCTION. THE LENS REQUIRED EXPLANTATION. NO RESISTANCE WAS NOTED WHEN TWISTING THE INJECTOR DURING LENS INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030160 ↗
• MalfunctionNov 19, 2025Crack; Ejection Problem; Crack; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS NOT RELEASING THE LENS CORRECTLY DURING INJECTION. THROUGH FOLLOW UP, WE LEARNED THAT THE IOL WOULD NOT RELEASE FROM THE INSERTER DURING IMPLANTATION. THE SURGEON HAD TO WITHDRAW THE DEVICE. THE TIP OF THE CARTRIDGE APPEARED TO BE SPLIT. THERE WAS NO PATIENT INJURY REPORTED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600980 ↗
• MalfunctionNov 7, 2025Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTICS STUCK TOGETHER INSIDE THE EYE. THE SURGEON EMPLOYED A SECOND INSTRUMENT TO SEPARATE THE HAPTICS, WHICH CAUSED A DELAY OF APPROXIMATELY ONE MINUTE. THE PATIENT¿S STATUS WAS UNKNOWN, AND DAILY ACTIVITIES WERE NOT AFFECTED. THE INCISION WAS NOT ENLARGED, A VITRECTOMY WAS NOT PERFORMED, AND NO MEDICATIONS WERE ADMINISTERED. THE PATIENT DID NOT SEEK MEDICAL ATTENTION, AND IT IS UNCLEAR WHETHER SUTURES WERE REQUIRED. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500782 ↗
• MalfunctionOct 20, 2025Ejection Problem; Ejection Problem

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) DEPLOYED INTO THE PATIENT'S EYE UPSIDE DOWN, THE LENS HAD TO BE FLIPPED, AND CUT OUT. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP DCB00 17.0 DIOPTER IOL. THERE WAS NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337538 ↗
• MalfunctionJul 18, 2025Use of Device Problem; Ejection Problem; Use of Device Problem; Ejection Problem

  THE DCB00 MODEL INJECTOR DID NOT FIT PROPERLY IN THE WOUND, THEREFORE INTRAOCULAR LENS (IOL) ADVANCED TOO EARLY AND WAS STUCK IN THE WOUND; THEREFORE, IT WAS NOT FULLY INSERTED. THE IOL WAS REMOVED. THERE WAS NO PATIENT INJURY AND THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE. OPERATIONAL USE ERROR WAS REPORTED ALTHOUGH, NO DETAILS WERE PROVIDED. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22548717 ↗
• MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE DOCTOR THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A DEFECT AND WAS TORN BEFORE HE STARTED LOADING IT. THIS ITEM WAS DISCARDED AND THIS DEVICE NEVER TOUCHED THE PATIENT AND THERE WAS NO USE ERROR. THE PROCEDURE WAS COMPLETED WITH A BACKUP IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755153 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FAULTY NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345891 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE AND REMOVED DURING THE SAME PROCEDURE BECAUSE OF A CRACK IN THE LENS. THE LENS WAS REPLACED WITH A LENS OF SAME MODEL AND DIOPTER. THE CRACK IN THE LENS WAS NOT DUE TO USE ERROR. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233805 ↗
• MalfunctionNov 27, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE SURGEON NOTICED FIBERS ON THE TECNIS SIMPLICITY PRELOADED MONOFOCAL INTRAOCULAR LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212721 ↗
• InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MECHANICAL COMPLICATIONS WHICH THE LENS WAS DISLOCATED. THE DOCTOR TRIED TO REPOSITION THE LENS, BUT WAS UNABLE TO DO SO; THEREFORE, DECIDED TO REMOVE THE LENS. THE INCISION WAS ENLARGED, A VITRECTOMY WAS DONE, AND A NON-JOHNSON & JOHNSON SULCUS LENS OF 16.5 DIOPTER WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL. THE LENS IS NOT BEING RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17760696 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FULLY INSERTED INTRAOCULAR LENS (IOL) HAD TO BE CUT OUT AND REMOVED FROM THE PATIENT¿S LEFT EYE. THERE WAS A CAPSULE TEAR AFTER THE LENS WAS INSERTED; THEREFORE, A VITRECTOMY WAS PERFORMED AND 10-0 VICRYL SUTURES WERE PLACED. IT IS UNKNOWN IF THE CAPSULE TEAR WAS DUE TO THE PATIENT ANATOMY ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER JOHNSON AND JOHNSON POSTERIOR CHAMBER LENS OF DIFFERENT MODEL AND DIOPTER (ZA9003, 16.5) DURING THE SAME PROCEDURE. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 17240017 ↗
• MalfunctionDec 13, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS (IOL) HAPTIC WAS KINKED WHILE LOADING, DURING HANDLING AND PRIOR TO INSERTION. REPORTEDLY THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP DCB00 17.0 IOL IN THE SAME PROCEDURE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS NO REPORTABLE ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966028 ↗
• MalfunctionAug 24, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ACCOUNT INDICATED THAT THE PRODUCT PACKAGING WAS OPENED BUT THE DEVICE WAS NOT USED. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287840 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED THAT THE TECNIS SIMPLCTY INTRAOCULAR LENS (IOL) MALFUNCTIONED. THERE IS NO INDICATION OF PATIENT INJURY AND THE LENS HAS BEEN WASTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424704 ↗
• MalfunctionDec 9, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) COULD NOT BE IMPLANTED BECAUSE THE IMPLANT EJECTED FROM THE CARTRIDGE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12973245 ↗
• MalfunctionSep 9, 2021Break; Inaccurate Delivery; Mechanical Jam; Break; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) GOT STUCK IN THE PLASTIC PUSHER INSIDE THE INSERTER WHEN THE SURGEON WENT TO ADVANCE THE LENS INTO THE EYE. SHE ATTEMPTED TO UNSTICK THE LENS USING ANOTHER INSTRUMENT AND IN DOING SO THE BALL AT END OF HAPTIC STAYED STUCK TO THE PLASTIC BAR WHILE THE REST OF THE LENS CAME OUT. SHE FELT THAT THERE WAS ENOUGH OF THE HAPTIC LEFT ON IOL TO SAFELY STAY IN THE PATIENT'S EYE. THERE WAS NO VITRECTOMY REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12444846 ↗
• MalfunctionSep 7, 2021Crack; Crack

  IT WAS REPORTED INITIALLY THAT AN INTRAOCULAR LENS (IOL) WAS BROKEN. THERE WAS PATIENT CONTACT AND THE SAMPLE IS RETURNING. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT SPECIFICALLY THERE WAS A BROKEN SHOOTER NOT A BROKEN LENS. FURTHER INFORMATION WAS RECEIVED THAT THE PRODUCT INVESTIGATION INCLUDING VISUAL TESTING WAS COMPLETED AND ACTUAL DEVICE PROBLEM OF CARTRIDGE TIP DAMAGED/CRACKED WAS CONFIRMED, MAKING THE EVENT REPORTABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436663 ↗
• MalfunctionJun 23, 2021Break; Material Too Rigid or Stiff; Scratched Material; Break; Material Too Rigid or Stiff; Scratched Material

  IT WAS REPORTED THAT THERE WAS RIGIDITY WHEN PUSHING THE PLUNGER FORWARD, THE LENS WAS SCRATCHED WHEN IT CAME OUT AND WITH BENT AND BROKEN HAPTICS. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP WE LEARNED THAT THE PLUNGER DID NOT PUSH THE LENS CORRECTLY DUE TO THE RIGIDITY, PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055196 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT A DCB00 MODEL INTRAOCULAR LENS(IOL) WAS CRUSHED. THIS EVENT WAS OBSERVED UPON OPENING OF PACKAGE. THERE WAS NO PATIENT CONTACT. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022074 ↗
• InjuryJun 11, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC WAS STUCK IN THE INJECTOR AS THE LENS WAS BEING INSERTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE) AND THE HAPTIC TORE FROM THE LENS; THERE WAS PATIENT CONTACT WITH THE PRODUCT. THE SURGEON ENLARGED THE WOUND, REMOVED THE LENS AND, SUTURES WERE PLACED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO SERIOUS PATIENT INJURY AND NO UNPLANNED VITRECTOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986270 ↗
• MalfunctionJun 4, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A SURGEON HAD AN ISSUE WITH ONE OF OUR PRELOADED LENSES. THE SURGEON INJECTED THE PRELOADED PRODUCT, A MISSING TRAILING HAPTIC OCCURRED. THEY HAD TO CUT THE LENS & INSERT ANOTHER ONE. IT WAS STATED THAT THE LENS WAS NOT IN THE EYE; DIDN'T SEE IT THE INSERTER, AND THAT IT WAS THE FIRST TIME FOR THE NURSES AS WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942388 ↗