TECNIS SIMPLICITY DCB00 (REF DCB0000135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474635951), received between Jun 23, 2021 and Feb 6, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE A BROKEN LEADING HAPTIC. THERE WAS NO PATIENT CONTACT WITH ANY PART OF THE DEVICE, AND NO MEDICAL OR SURGICAL INTERVENTIONS OUTSIDE THE NORMAL STANDARD OF CARE WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284997 ↗
• MalfunctionDec 18, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND WITH A BROKEN HAPTIC AND WAS STUCK, INDICATING A PRODUCT MALFUNCTION DURING USE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846582 ↗
• MalfunctionJun 26, 2025Device Difficult to Setup or Prepare; Ejection Problem; Device Difficult to Setup or Prepare; Ejection Problem

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS DROPPED OUT OF THE EYE WHEN BEING IMPLANTED. THE TECHNICIAN INFORMED THE SURGEON THAT THE KNOB FELT STIFF THEN THE SURGEON PLACED THE TIP OF THE CARTRIDGE ON PATIENT'S EYE READY TO IMPLANT AND NOTED THAT WHAT THE TECH MENTIONED WAS TRUE. THE SURGEON PULLED OUT INJECTOR AND TRIED TO TWIST KNOB AGAIN WHEN LENS DROPPED. THERE WAS PATIENT CONTACT HOWEVER, THE IOL DID NOT ENTER THE CAPSULAR BAG COMPLETELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DCB00 13.0 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, AND NO COMPLICATIONS. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342231 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CATARACT INTRAOCULAR LENS (IOL) REPLACEMENT SURGERY IN THE OPERATING ROOM. DURING THE SURGERY, THE SURGEON OPENED THE PACKAGE AND FOUND THAT THE HAPTIC OF MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) WAS CREASED AND BROKEN. LENS WAS IMMEDIATELY REPLACED THEM WITH NEW ONE. ISSUE WAS NOTICED PRIOR TO USE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684753 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), SERIAL: (B)(6), BECAME FAULTY DURING SURGERY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315659 ↗
• MalfunctionSep 19, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE SCRATCH WAS ON THE OPTIC OF THE LENS. IT WAS ALSO REPORTED THAT THE LENS IS NOT AVAILABLE FOR RETURN AS THE LENS HAS BEEN IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263606 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO DYSPHOTOPSIA. THE ISSUE WAS FIRST OBSERVED DURING THE POST OPERATIONAL EXAMINATION. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (+17.5D) WAS USED AS A REPLACEMENT. NO MEDICAL AND NO OTHER SURGICAL INTERVENTIONS SUCH AS VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. THE PATIENT HAS FULLY RECOVERED AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 20164231 ↗
• MalfunctionApr 7, 2023Scratched Material; Scratched Material

  IT WAS REPORTED WHEN INSERTING THE PRE-LOADED DCB00 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE THE DOCTOR SAW A DIVOT ON THE OPTIC. LENS WAS CUT IN HALF WITH MICROSURGICAL TECHNOLOGY (MSTS) AND REMOVED WITH UTROTTAS AND ANOTHER LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO PATIENT INJURY. DOCTOR STATED THIS LOOKS FINE. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702678 ↗
• 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 BALANCED SALT SOLUTION (BSS) AND SAT FOR MORE THAN 3-5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487166 ↗
• InjuryNov 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF MECHANICAL COMPLICATION, THE PATIENT WANTED TO SEE BETTER. THE IOL WAS REPLACED WITH ANOTHER LENS WITH THE SAME MODEL AND DIFFERENT DIOPTER SIZE, 12.0 DIOPTER. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GREAT. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 12776782 ↗
• MalfunctionNov 7, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF A PRELOADED INTRAOCULAR LENS (IOL) "BURSTED' AT THE FRONT DURING IMPLANTATION. THE LENS WAS FULLY INSERTED. THERE WAS NO PATIENT HARM AND NO FURTHER INTERVENTION WAS NECESSARY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756113 ↗
• MalfunctionNov 3, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED AND NEEDED TO BE REPLACED. ACCOUNT'S BRIEF DESCRIPTION OF THE EVENT PROVIDED THAT THE LENS WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE; HOWEVER, THE IOL HAD TO BE REMOVED AS THERE WAS SOMETHING ON IT. THERE WAS NO PATIENT INJURY REPORTED. ACCOUNT INDICATED THAT INCISION WAS ENLARGED AND LENS WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 12748730 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS(IOL), MODEL DCB00, HAD A BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316829 ↗
• MalfunctionJul 6, 2021Break; Mechanical Problem; Use of Device Problem; Break; Mechanical Problem; Use of Device Problem

  CUSTOMER REPORTED LOADING ISSUE, BENT/BROKEN HAPTIC, AND PLUNGER OVERRODE THE LENS. NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124980 ↗
• 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, IN SOME CASES THE SCRATCHED LENS CAME OUT AND IN OTHER CASES THE LENS 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, THE SUSPECT PRODUCT FOR THIS EVENT IS NOT AVAILABLE FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054895 ↗