TECNIS SIMPLICITY DCB00 (REF DCB0000140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474635968), received between Sep 7, 2021 and Apr 23, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  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 24971843 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE CUSTOMER SPECIFIED THAT THE IOL WAS DEFECTIVE AND NOT THE CARTRIDGE. THE HAPTIC LOOK DAMAGED. THE DEVICE DIDN'T MAKE ANY CONTACT WITH THE PATIENT. FOLLOW-UP WAS PERFORMED HOWEVER NO MORE INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587384 ↗
• MalfunctionDec 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A WHITE FIBER INSIDE THE DELIVERY SYSTEM. THE LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE WHITE FIBER WAS INTRODUCED INTO THE PATIENT'S EYE, AND THE SURGEON SUSPECTS IT CAME FROM THE LENS INJECTOR WITH A FIBER ATTACHED TO THE UNDERSIDE OF THE LENS. THE SURGEON ASPIRATED THE FIBER USING THE ASPIRATION HANDPIECE. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. THE INJECTOR IS AVAILABLE TO RETURN, HOWEVER, THE FIBER IS NOT AVAILABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846386 ↗
• MalfunctionNov 14, 2025Break; Break

  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 23560265 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PHOTOPSIA. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER COMPANY¿S IOL. NO INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. THE PRE-VISUAL ACUITY WAS 20/30-2, AND THE POST-OPERATIVE VISUAL ACUITY IS RECORDED AS 20/30-1. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 23069806 ↗
• MalfunctionSep 27, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH. THE IOL WAS FULLY INSERTED WHEN THEY NOTICED A BIG SCRATCH. A BACKUP JNJ LENS WITH THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327428 ↗
• MalfunctionJul 15, 2024Mechanical Jam; Scratched Material; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS GETTING STUCK WHEN BEING ADVANCED. LATER, WHEN THE LENS WAS IN THE EYE, A DEFECT ON THE IOL WAS NOTICED. THROUGH FOLLOW UPS WE LEARNED THAT THERE WAS A SCRATCH ON THE SURFACE OF THE LENS. THE IOL WAS IMMEDIATELY REMOVED AND REPLACED WITH A LENS OF THE SAME MODEL / DIOPTER. THE ORIGINAL LENS WAS DISCARDED. PATIENT IS DOING WELL. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746960 ↗
• MalfunctionJun 14, 2024Break; Break

  CUSTOMER ACCOUNT PROVIDED PHOTO/IMAGES OF THE DCB00 MODEL INTRAOCULAR LENS (IOL). PHOTO/IMAGES APPEAR TO SHOW A TEAR OR BREAK OF SOME SORT AT THE EDGE OF THE IOL, WHICH MAY BE CONSISTENT WITH THE COMPLAINT REPORTED (SURGEON IDENTIFIED A RUPTURE AT THE END OF THE IOL). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543497 ↗
• MalfunctionJun 4, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), A SCRATCH WAS NOTICED ON THE EDGE OF THE LENS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464432 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT THE SURGEON NOTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CRACKED WHEN INSERTING THE IOL INTO THE PATIENT'S EYE. THE SURGEON REMOVED AND REPLACED THE IOL DURING THE SAME SURGERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956561 ↗
• MalfunctionDec 8, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DID NOT UNFOLD UPON DEPLOYMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298007 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON INSERTED THE INTRAOCULAR LENS (IOL) LENS AND THEN HAD TO CUT IT OUT AND A VITRECTOMY WAS PERFORMED. IT WAS STATED THAT THERE WAS CAPSULE TEAR, SO IOL WAS REMOVED FROM THE PATIENT'S LEFT EYE AND REPLACED WITH A NON JOHNSON AND JOHNSON IOL DURING THE SAME PROCEDURE. AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE PATIENT WAS WELL POST-OPERATIVELY (OP) AND NO PRODUCT WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17253063 ↗
• MalfunctionApr 14, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND COULD NOT BE IMPLANTED. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748082 ↗
• MalfunctionMar 6, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) CARTRIDGE TEARS AT THE END WHILE INSERTING THE LENS INTO THE PATIENT'S OPERATIVE EYE. THIS OCCURS AS THE SURGEON SCREWS THE LENS THROUGH INTO THE EYE. THE IMPLANT ALSO HAS SOME SMALL LITTLE DEFECTS ON IT. THE SURGEON SEES ABNORMALITIES ON THE LENS. NURSE ASSURED SHE FILLED THE CARTRIDGE WITH BSS AND SAT FOR MORE THAN 3-5 MINUTES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486630 ↗
• MalfunctionOct 25, 2022Mechanical Problem; Scratched Material; Mechanical Problem; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) OVERRODE THE INJECTOR AND BECAME SCRATCHED. THERE WAS NO PATIENT CONTACT. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671425 ↗
• MalfunctionAug 15, 2022Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE OF THE PRELOADED INTRAOCULAR LENS (IOL) DEVICE WAS BROKEN/CRACKED. THE LENS WAS PARTIALLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15230406 ↗
• MalfunctionSep 7, 2021Inaccurate Delivery; Appropriate Device Problem Term/Code Not Available; Inaccurate Delivery; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DCB00 MODEL INTRAOCULAR LENS(IOL) FAILED TO EJECT THE LENS CORRECTLY, THE INSERTER HOOKED ON THE BACK HAPTIC AND THE LENS THEN RELEASED FROM THE CARTRIDGE DUE TO THE PRESSURE OF FAILED INSERTER. THERE WAS PATIENT CONTACT WITH PATIENT'S RIGHT EYE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. NO MEDICAL/ SURGICAL INTERVENTIONS WERE DONE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437044 ↗