TECNIS SIMPLICITY DCB00 (REF DCB0000230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 05050474636149), received between Jan 6, 2021 and Aug 12, 2026 — classified as 13 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Break; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229790 ↗
• MalfunctionJul 16, 2026Failure to Fold; Mechanical Jam; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834809 ↗
• MalfunctionJun 1, 2026Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, RESISTANCE WAS ENCOUNTERED DURING INJECTION. AFTER FORCIBLY WITHDRAWING, MOST OF THE FOLDED LENS WAS REMOVED; HOWEVER, THE REMAINING PORTION OF THE LENS AND HAPTIC WERE CUT AND REMOVED. THE IMPLANTED LENS WAS REPORTED TO BE STABLE, WITH NO EVIDENCE OF ROTATION, DISPLACEMENT, OR DECENTRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356145 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN PATIENT'S RIGHT EYE. DURING A FOLLOW-UP CHECK-UP ON THE SAME DAY, THE PATIENT EXPERIENCED ELEVATED PRESSURE IN HIS VISION AND WAS ADMINISTERED EYE DROPS, FOLLOWED BY A 45-MINUTE WAITING PERIOD. UPON RE-EXAMINATION, THE PRESSURE REMAINED HIGH, AND THE PATIENT WAS ADVISED TO CONSULT THE SURGEON. THE PATIENT STATED THAT HIS VISION HAD NOT IMPROVED, REMAINED FOGGY, AND THAT HE OBSERVED RAINBOW COLORS WHEN LOOKING AT LIGHTS. THE FOLLOWING DAY, THE PATIENT REPORTED A SLIGHT IMPROVEMENT IN HIS VISION, THOUGH IT REMAINED FOGGY WITH PERSISTENT RAINBOW EFFECTS WHEN LOOKING AT THE LIGHTS. THE PATIENT CONFIRMED THE SURGEON HAD PROVIDED EYE DROPS AND DISCHARGED HIM TO RECOVER AT HOME. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Halo; Intraocular Pressure Increased

  MAUDE report 24918251 ↗
• MalfunctionApr 11, 2026Crack

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CARTRIDGE TIP HAD A JAGGED EDGE DURING THE IMPLANTATION OR APPLICATION PROCESS., THE LENS WAS FULLY INSERTED. NO ADDITIONAL INFORMATION REGARDING DEVICE PERFORMANCE OR PATIENT IMPACT WAS PROVIDED, AND PATIENT DETAILS ARE UNAVAILABLE DUE TO PRIVACY LEGISLATION OR POLICY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849357 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS WAS FOUND TO HAVE A BROKEN HAPTIC. THE DEVICE WAS NOT USED, AND NO PATIENT EXPOSURE OCCURRED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618618 ↗
• MalfunctionMar 5, 2026Ejection Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE HAPTIC BECAME STUCK INSIDE THE CARTRIDGE WHEN THE IOL WAS 90% DELIVERED INTO THE PATIENT'S EYE. THE SURGEON USED FORCEPS TO REMOVE THE IOL FROM THE CARTRIDGE AND POSITION THE HAPTIC WITHIN THE CAPSULAR BAG. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523789 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. THE LENS APPEARED DAMAGED AND WAS REMOVED DURING THE SAME PROCEDURE, THEN REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR MEDICATIONS OUTSIDE OF STANDARD CARE WERE REQUIRED. THE PATIENT¿S OUTCOME WAS GOOD, AND NO INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254702 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED BY THE CUSTOMER THAT, DURING HANDLING AND BEFORE INSERTION OF A PRELOADED INTRAOCULAR LENS, THE DOCTOR NOTICED AN UNUSUAL APPEARANCE OF THE LENS. UPON PLACING THE LENS ON GAUZE FOR CLOSER INSPECTION, IT WAS FOUND TO BE CRACKED. THERE WAS NO CONTACT WITH THE PATIENT¿S EYE AND THE PATIENT WAS NOT INVOLVED IN THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242840 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT REPORTED PERSISTENT DYSPHOTOPSIA SYMPTOMS WHICH LASTED APPROXIMATELY 5 MONTHS. REPORTEDLY, THE IOL DIRECTIONS FOR USE WERE FOLLOWED AND THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY SUTURES OR DELAY IN THE PROCEDURE. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS, MODEL LENSTEC SOFTEC HDO +22.25. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 24090636 ↗
• MalfunctionNov 24, 2025Break; Device Difficult to Setup or Prepare; Failure to Advance; Break; Device Difficult to Setup or Prepare; Failure to Advance

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPROPERLY LOADED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AS THE ISSUE WAS DETECTED PRIOR TO THE LENS COMING INTO CONTACT WITH THE PATIENT. THERE WAS RESISTANCE AND A CRUNCHING SOUND NOTED DURING THE PRIMING/LOADING PROCESS. THE SURGEON DECIDED NOT TO USE THE IOL DUE TO THE OBSERVED PROBLEM. THE LENS WAS NOT IMPLANTED, AND NO HARM WAS CAUSED TO THE PATIENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640339 ↗
• MalfunctionNov 21, 2025Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP WAS CHIPPED; HOWEVER, THE DOCTOR STILL IMPLANTED THE PRELOADED INTRAOCULAR LENS (IOL), WHICH WAS NOT DAMAGED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619521 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON NOTED A DEFECT ALONG THE EDGE OF THE IOL WHICH WAS ONLY VISIBLE UNDER THE MICROSCOPE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609334 ↗
• 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 23600578 ↗
• MalfunctionAug 1, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DID NOT FIRE PROPERLY DURING A SURGICAL PROCEDURE. THE LENS WAS PARTIALLY INSERTED. IT WAS ALSO REPORTED THAT THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE PATIENT RECOVERED FULLY FOLLOWING THE OPERATION WITH NO COMPLICATIONS, NO PERMANENT IMPAIRMENT OR THE NEED FOR ADDITIONAL MEDICAL INTERVENTION, WERE NOTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689258 ↗
• MalfunctionJul 28, 2025Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS CARTRIDGE WAS MALFUNCTIONED WHEN IT WAS BEING INSERTED INTO THE PATIENTS EYE. THERE WAS NO ADVERSE AFFECT OR INJURY AND NO SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SAME MODEL DIFFERENT LENS. INVESTIGATION CONFIRMED THAT CARTRIDGE WAS DEFORMED AND DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637346 ↗
• MalfunctionMar 31, 2025Contamination; Contamination

  IT WAS REPORTED BY THE DOCTOR THAT AN ADHESIVE STRAND WAS OBSERVED ON THE PERIPHERAL BACKSIDE OF AN OPTIC LENS ON PRELOADED DCB00. THE STRAND WAS SUCCESSFULLY REMOVED USING AGGRESSIVE IRRIGATION ASPIRATION AND NO PATIENT COMPLICATIONS WERE REPORTED. THE INTRAOCULAR LENS REMAINED SUCCESSFULLY IMPLANTED AND THE STRAND WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735581 ↗
• MalfunctionMar 20, 2025Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS OPENED AND NOTICED THAT THE SEAL OF THE BOX WAS BROKEN PRIOR TO USE, LEADING TO ITS DESTRUCTION. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT PRODUCT WAS NOT RECEIVED WITH BROKEN LENS BOX SEAL. REPORTEDLY THERE WAS A BREACH OR POTENTIAL BREACH IN THE STERILE BARRIER THAT IS NOT DUE TO SHIPPING DAMAGE OR USE ERROR. THE LENS WAS NOT CONTAMINATED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657368 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED, THE IOL WAS OPENED NOT USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612817 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS A POTENTIAL DEFECT OR THE LENS MAY HAVE BEEN TOO COLD. THE ISSUE WAS NOTICED DURING HANDLING/PRIOR TO INSERTION. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527766 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CRUMPLED WHEN THE PLUNGER WAS PUSHED FORWARD DURING PREPARATION. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING A BACK UP IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370699 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS FOUND TO BE DEFECTIVE. THIS WAS NOTED BY THE SURGEON PRIOR TO IMPLANTATION. A BACK UP LENS WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279152 ↗
• MalfunctionJan 9, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH ON IT. THE SURGEON HAD TO USE MST (MICROSURGICAL INSTRUMENT) HANDLE AND CUTTERS TO REMOVE THE LENS, THEN REPLACED IT IN THE SAME PROCEDURE USING A BACK UP IOL. NO PATIENT INJURY OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118343 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A DEFECTIVE HAPTIC. THERE WAS NO PATIENT CONTACT. IT WAS ALSO REPORTED THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY. UNPLANNED SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061780 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, HOWEVER, THE EYE STARTED LEAKING. IT WAS REPORTED PROBLEM WAS DUE TO PATIENT ANATOMY. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL A Z9003 21.5 DIOPTER. SUTURES WERE REQUIRED AND THERE WAS A 15 MINUTE DELAY. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW UP, IT WAS LEARNED THERE WAS NO NOTATION OF A CAPSULE TEAR. AND AN INCISION ENLARGEMENT OR VITRECTOMY WAS NOT REQUIRED. THE SUTURES WERE CONFIRMED AS UNPLANNED. IT WAS UNKNOWN WHAT THE PATIENT ANATOMY ISSUE WAS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 21049172 ↗