TECNIS SIMPLICITY DCB00 (REF DCB0000165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05050474636019), received between Aug 13, 2021 and May 11, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THAT THE IMPLANT WAS ONLY PARTIALLY INSERTED INTO THE PATIENT¿S EYE. IT WAS ALSO REPORTED THE LENS WAS INSERTED AND SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE, AND THE INCISION WAS ENLARGED TO FACILITATE REMOVAL. THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT OUTCOME, THE NEED FOR SUTURES, OR VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 25145310 ↗
• MalfunctionApr 19, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921187 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A SINGLE-PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT USED DUE TO A BENT OBSERVED IN THE LOADER. THERE WAS NO PATIENT CONTACT OR INJURY. THE IOL WAS DISCARDED AND NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329232 ↗
• MalfunctionSep 3, 2025Crack; Crack

  IT WAS REPORTED THAT THE AFTER OPENING THE PRELOADED MONOFOCAL INTRAOCULAR LENS AND VIEWING IT UNDER THE MICROSCOPE, IT WAS NOTICED THAT THE CARTRIDGE WAS CRACKED DOWN ON BOTH SIDES. THE PRODUCT HAD PATIENT CONTACT, BUT THE LENS WAS NOT IMPLANTED. BASED ON THE INVESTIGATION RESULT, IT WAS CONFIRMED THAT THE DAMAGE WAS NOTICED AT THE TIP OF THE CARTRIDGE. THE PROCEDURE WAS COMPLETED USING BACKUP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959464 ↗
• MalfunctionAug 15, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE. AFTER UNFOLDING, IT WAS FOUND THAT THERE WAS A SCRATCH ON THE LENS SURFACE. IT WAS CONSIDERED THAT THE SCRATCH WAS CLOSE TO THE EDGE. THE LENS WAS NOT REPLACED. THE PATIENT WAS FOLLOWED UP FOR OBSERVATION. THE PATIENT RETURNED FOR EYE EXAMINATION BUT DID NOT COMPLAIN OF OBVIOUS DISCOMFORT. IOL REMAINS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815187 ↗
• MalfunctionJun 16, 2025Contamination; Contamination

  IT WAS REPORTED THAT THAT DURING THE IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON DISCOVERED A BLACK FIBER INSIDE THE PATIENT'S RIGHT EYE. THE FIBER WAS SUCCESSFULLY REMOVED WITHOUT ANY COMPLICATIONS. THE LENS WAS FULLY INSERTED DURING THE PROCEDURE. THROUGH FOLLOW UP, IT WAS CONFIRMED THE LENS IS STILL IMPLANTED. IT DID NOT COMPLICATE THE SURGERY OTHER THAN HAVING TO REMOVE THE FIBER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216422 ↗
• MalfunctionApr 29, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A MARK ON THE OPTIC, THEREFORE, THE SURGEON REMOVED IT FROM THE PATIENT'S RIGHT EYE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE THE STANDARD OF CARE REQUIRED. THE IOL HAD TO BE CUT IN HALF TO BE REMOVED FROM THE PATIENT'S EYE DURING THE SAME SURGERY AND ANOTHER LENS WAS IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930705 ↗
• MalfunctionOct 3, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE CUSTOMER FOUND A PRODUCT ISSUE. RIGHT AFTER IMPLANTATION. PHYSICIAN DISCOVERED A RED FIBER AND WAS REMOVED WITH AN INTRAOCULAR LENS (IOL) MANIPULATOR. PHYSICIAN USES BASAL SALINE SOLUTION (BSS) TO IRRIGATE THE TIP OF THE MANIPULATOR AND FOUND THE FIBER IN THE SOLUTION. IOL REMAINS IN PATIENT EYE. PATIENT OUTCOME IS THAT PATIENT IS DOING FINE. PHYSICIAN FEELS THAT FIBER CAME FROM IOL. THE RED FIBER IS BEING SENT BACK TO US FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364267 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENSES (IOL) WERE DEFECTIVE. ONE WAS FOUND WITH A HOLE AND ONE WAS FOUND CRACKED. BOTH WERE IMPLANTED IN THE SAME PATIENT AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A LENS OF THE SAME POWER BUT FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT CAPTURES THE EVENT FOR ONE OF THE TWO REPORTED DEVICES. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE ADDITIONAL DEVICE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697404 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENSES (IOL) WERE DEFECTIVE. ONE WAS FOUND WITH A HOLE AND ONE WAS FOUND CRACKED. BOTH WERE IMPLANTED IN THE SAME PATIENT AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A LENS OF THE SAME POWER BUT FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT CAPTURES THE EVENT FOR ONE OF THE TWO REPORTED DEVICES. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE ADDITIONAL DEVICE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697374 ↗
• MalfunctionApr 29, 2024Break; Break

  IT WAS REPORTED THAT THE PISTON BROKE THE LEG OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). NO FURTHER DETAIL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205959 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED LENS HAD OPENED BUT NOT USED. ADDITIONAL INFORMATION REVEALED THAT THE LEAD HAPTIC WAS BROKEN WHEN THE LENS WAS ADVANCED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN UNKNOWN MODEL BACKUP LENS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND A VITRECTOMY WAS NOT REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603217 ↗
• MalfunctionJan 16, 2024Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE CUSTOMER HAS HAD ISSUES OPENING THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), IN PARTICULAR NOT FOLDING CORRECTLY DURING PROCEDURE. PATIENT STATUS IS UNKNOWN. THROUGH FOLLOW UP WE LEARNED THAT THE SURGEON HAD DIFFICULTY ADVANCING THE LENS AND ONCE ADVANCED, THE LENS LOOKED ODD. FURTHER FOLLOW UP REVEALED THAT THERE WAS NO PATIENT INVOLVEMENT WITH THE DEVICE AND NO MATERIAL WAS AVAILABLE FOR RETURN AS THE DEVICE HAS ALREADY BEEN DISCARDED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521301 ↗
• MalfunctionNov 10, 2023Crack; Crack

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS USED IN A SURGERY AND THE SURGEON IMPLANTING THE LENS, NOTICED ISSUES WITH THE CARTRIDGE TIP. THE LENS WAS USED WITHOUT INCIDENT AND THE PATIENT WAS NOT IMPACTED BY THE ISSUE. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER INDICATED THAT THE TIP OF THE CARTRIDGE WAS DEFECTIVE, HAD A BURR ON IT AND WAS MISSHAPED. THE ISSUE WAS NOTED RIGHT BEFORE INSERTION. THE HAPTIC OR OPTIC OF THE LENS WAS NOT DAMAGED. IT WAS INDICATED THAT THE DAMAGE WAS NOT DUE TO USE ERROR. THE PROCEDURE COMPLETED WITH THE SAME IOL AND CARTRIDGE. NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY OR ADVERSE OUTCOMES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108469 ↗
• MalfunctionAug 1, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE PATIENT¿S OPERATIVE EYE, HOWEVER, THE SURGEON HAD TO CUT THE IOL AND REMOVE IT FROM THE EYE FOR ONE OF THE HAPTICS BROKE OFF. THE SURGERY COMPLETED DURING THE SAME PROCEDURE USING A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS. NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PATIENT WAS SEEN AT THE POST-OP VISIT AND ALL LOOKED GREAT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438690 ↗
• MalfunctionJul 31, 2023Break; Break

  IT WAS REPORTED THAT THE DCB00 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S RIGHT EYE AND WAS REMOVED DURING THE SAME PROCEDURE DUE TO BENT HAPTIC. THE REPLACEMENT IOL WAS ANOTHER ZA9003 16.5 DIOPTER IOL. THERE WAS NO PATIENT ISSUES AND THERE IS NO INDICATION OF MEDICAL AND/OR SURGICAL INTERVENTION. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FINE. THE SUSPECT IOL IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424693 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT A HAPTIC BROKE OFF DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL). THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH THE SAME LENS MODEL. THROUGH FOLLOW-UP WE LEARNED THAT THE HAPTIC DID NOT BREAK DUE TO USE ERROR AS THE OPERATING STAFF IS EXPERIENCED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542391 ↗
• MalfunctionMay 21, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, HAD TO BE REMOVED FROM THE EYE AS THE LENS HAD A HOLE IN IT. THE INCISION WAS ENLARGED AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT WAS FINE POST OPERATION. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14466741 ↗
• MalfunctionFeb 8, 2022Scratched Material; Scratched Material

  CUSTOMER REPORTED THEY NOTICED THE IOL WAS SCRATCHED DURING HANDLING OF THE PRODUCT. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477535 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT A FULLY INSERTED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DUE TO NOTICING THAT THE HAPTIC BROKE DURING INSERTION. A BACKUP LENS OF THE SAME MODEL AND DIOPTER POWER WAS IMPLANTED AS THE REPLACEMENT IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTIONS. THE PATIENT IS DOING WELL POST OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13405206 ↗
• MalfunctionDec 29, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED DURING PRODUCT HANDLING AND PRIOR TO INSERTION THE PRE-LOADED INTRAOCULAR LENS (IOL) HAPTIC BENT WHEN OPENED AND THE LENS POPPED OUT. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112844 ↗
• MalfunctionNov 2, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) THE SURGEON NOTICED MARKS ON THE IOL FROM THE INJECTOR. THE IOL WAS CUT OUT TO BE REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741565 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL DCB00, WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO A LENS ISSUE. ACCOUNT INDICATED THAT THE LENS WAS PARTIALLY INSERTED IN THE PATIENT'S RIGHT EYE WHEN DOCTOR NOTICED LENS WAS FAULTY AND RETRACTED IT BACK INTO THE CARTRIDGE. THE PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON AND JOHNSON IOL OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321496 ↗