TECNIS SIMPLICITY DCB00 (REF DCB0000190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 05050474636064), received between Mar 31, 2021 and Aug 4, 2026 — classified as 14 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133627 ↗
• MalfunctionJul 29, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073359 ↗
• MalfunctionJul 6, 2026Break

  IT WAS REPORTED THAT HAPTIC WAS FAULTY NO PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725050 ↗
• MalfunctionJun 16, 2026Crack

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) WAS CRACKED. THE IOL WAS IMPLANTED. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT WAS EXAMINED 24 HOURS POST-PROCEDURE AND WAS IN GOOD OVERALL HEALTH. ACCOUNT NOTED THAT THE SURGERY WENT VERY WELL, NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524615 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED WHICH WAS NOTED UPON OPENING THE PRODUCT PACKAGING. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019434 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, WAS FULLY IMPLANTED IN THE PATIENT¿S RIGHT EYE. DURING A POST-OPERATIVE VISIT, A REFRACTIVE SURPRISE WAS NOTED, AND THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. THE PATIENT¿S CURRENT STATUS AND IMPACT ON DAILY ACTIVITIES WERE UNKNOWN. NO INCISION ENLARGEMENT, VITRECTOMY, UNPLANNED SUTURES, OR PROCEDURAL DELAYS WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE ADMINISTERED. BEST-CORRECTED VISUAL ACUITY WAS 20/40 PRE-OPERATIVELY; POST-OPERATIVE VISUAL ACUITY WAS UNKNOWN. THE DIRECTIONS FOR USE WERE FOLLOWED. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THE REPLACEMENT INTRAOCULAR LENS WAS OF THE SAME MODEL, WITH A 3.5-DIOPTER DIFFERENCE (DCB00, 15.5 D).

  Patient problems: Visual Impairment

  MAUDE report 24944588 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OPENED AND CORRECTLY FILLED WITH VISCOELASTIC; HOWEVER, AT THE MOMENT OF ENGAGEMENT, IT BROKE. THEREFORE, THE CUSTOMER WAS UNABLE TO PROCEED WITH THE IMPLANTATION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24920944 ↗
• MalfunctionNov 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS MISSING A HAPTIC. IT WAS CONFIRMED THAT THE LENS WAS NOT IMPLANTED, AND THERE WAS NO CONTACT WITH THE PATIENT¿S EYE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23516459 ↗
• MalfunctionOct 29, 2025Ejection Problem; Ejection Problem

  DURING IMPLANTATION, THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND FOUND TO BE PREMATURELY ADVANCED. THERE WAS NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), AND NO VITRECTOMY. A NEW LENS WAS OPENED AND USED TO COMPLETE THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT 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 23420928 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DYSPHOTOPSIA FOLLOWING THE IMPLANTATION OF THE MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE. THE SYMPTOMS PERSISTED FOR FIVE MONTHS AND THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE LENS WAS LATER EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL WITH +18.5 DIOPTER. NO UNPLANNED COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, WERE REQUIRED DURING THE PROCEDURE. IT WAS REPORTED THAT THE DIRECTIONS FOR USE HAD BEEN FOLLOWED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23391958 ↗
• InjuryOct 17, 2025Adverse 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 INSERTED AND HAD TO BE REMOVED. PART OF EYE HAD TO BE DRAINED. PATIENT STATUS IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23330158 ↗
• InjurySep 9, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED DURING A SURGICAL PROCEDURE, AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED DUE TO DAMAGE OBSERVED ON THE OPTIC AND A SPLIT ON THE SIDE OF THE LENS. THE ISSUE WAS IDENTIFIED AFTER IMPLANTATION. THE LENS WAS REPLACED WITH ANOTHER IOL IN THE SAME PROCEDURE. NO PATIENT HARM WAS EVIDENT AT THE TIME, AND THE PATIENT¿S PROGNOSIS IS GOOD, WITH A FOLLOW-UP SCHEDULED IN 3-4 WEEKS. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012051 ↗
• MalfunctionJul 30, 2025Crack; Crack

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE PHYSICIAN OBSERVED AN IRREGULARITY IN THE TIP OF THE INJECTOR. THE ACCOUNT ALSO INDICATED THAT THIS IRREGULARITY MADE IT IMPOSSIBLE TO IMPLANT THE LENS IN THE USUAL MANNER, NECESSITATING THE DISASSEMBLY OF THE INJECTOR AND THE USE OF AN EXTRA CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671531 ↗
• MalfunctionJul 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS HAPTIC WAS BROKEN OFF DURING ADVANCEMENT IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475606 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT STATED SHE COULD BE ALLERGIC TO THE IMPLANTS AND SHE INDICATED SHE IS ALLERGIC TO POLYPROPYLENE. PATIENT IS REPORTING BLURRY VISION (DESCRIBED AS A FILM) AND GLARE, AS WELL AS HEADACHES BEHIND HER RIGHT EYE. SHE DESCRIBED THE BLURRINESS AS BEING LIKE A DROP OF OIL IS IN THE EYE. SHE STATES PRIOR TO THE IMPLANTS SHE HAD BLURRY VISION BUT IT WAS DIFFERENT. THE BLURRINESS WAS LOCALIZED, WHERE AS NOW IT IS MORE LIKE AN OVERALL FILM THAT GOES AWAY FOR A MOMENT WHEN SHE RUBS HER EYES. ALTHOUGH SHE WAS TOLD SHE HAD DRY EYE, SHE STATES HER EYES LEAK ALL THE TIME AND SHE GETS "CRUSTIES" IN THEM. HER OPHTHALMOLOGIST STATED SHE HAD DRY EYE, AND PRESCRIBED HER THREE (03) DIFFERENT MEDICINES. PRIMARILY SHE HAS BEEN USING SYSTANE, BUT MORE RECENTLY ROHTO MAXIMUM STRENGTH. SHE HAS LITTLE LUCK WITH SYSTANE, BUT INDICATED THE ROHTO WAS COOLING TO HER EYES. PRIOR TO CATARACT SURGERY THE PATIENT HAD HER RETINA REPAIRED AND IS STILL UNDER THE CARE OF A RETINA SPECIALIST. IN ADDITION SHE HAD EXPERIENCED LITTLE WHITE SPARKLES THAT WERE ATTRIBUTED TO HER HAVING HIGH BLOOD PRESSURE. SHE WAS TOLD BY HER

  Patient problems: Blurred Vision; Dry Eye(s); Headache; Visual Disturbances

  MAUDE report 22378755 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT STATED SHE COULD BE ALLERGIC TO THE IMPLANTS AND SHE INDICATED SHE IS ALLERGIC TO POLYPROPYLENE. PATIENT IS REPORTING BLURRY VISION (DESCRIBED AS A FILM) AND GLARE. SHE DESCRIBED THE BLURRINESS AS BEING LIKE A DROP OF OIL IS IN THE EYE. SHE STATES PRIOR TO THE IMPLANTS; SHE HAD BLURRY VISION BUT IT WAS DIFFERENT. THE BLURRINESS WAS LOCALIZED, WHERE AS NOW IT IS MORE LIKE AN OVERALL FILM THAT GOES AWAY FOR A MOMENT WHEN SHE RUBS HER EYES. ALTHOUGH SHE WAS TOLD SHE HAD DRY EYE, SHE STATES HER EYES LEAK ALL THE TIME AND SHE GETS "CRUSTIES" IN THEM. HER OPHTHALMOLOGIST STATED SHE HAD DRY EYE AND PRESCRIBED HER THREE (03) DIFFERENT MEDICINES. PRIMARILY, SHE HAS BEEN USING SYSTANE, BUT MORE RECENTLY ROHTO MAXIMUM STRENGTH. SHE HAS LITTLE LUCK WITH SYSTANE, BUT INDICATED THE ROHTO WAS COOLING TO HER EYES. PRIOR TO CATARACT SURGERY, THE PATIENT HAD HER RETINA REPAIRED AND IS STILL UNDER THE CARE OF A RETINA SPECIALIST. IN ADDITION, SHE HAD EXPERIENCED LITTLE WHITE SPARKLES THAT WERE ATTRIBUTED TO HER HAVING HIGH BLOOD PRESSURE. SHE WAS TOLD BY HER RETINA SPECIALIST THAT THERE WAS DEBRI

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 22378623 ↗
• MalfunctionMay 21, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066999 ↗
• MalfunctionMay 21, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066996 ↗
• InjuryMay 19, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A DELIVERY ISSUE WITH THE INJECTOR. THE LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE AND REPLACED WITH ZCB00 LENS WITH 19.0 DIOPTER IN THE SAME DAY. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048815 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT PRELOADED MONOFOCAL INTRAOCULAR LENS WAS COLLAPSED DURING LOADING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015036 ↗
• MalfunctionMar 25, 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 21689810 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT WHILE OPENING THE PRELOADED INTRAOCULAR LENS (IOL), THE SURGEON PUSHED THE INJECTOR FORWARD AND BROKE THE LENS. ACCOUNT PROVIDED THAT THE PRODUCT IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378492 ↗
• MalfunctionJan 30, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SMALL DIVOT ON OPTIC BODY OF A MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND. THE LENS WAS LEFT IN THE PATIENT'S EYE FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280407 ↗
• MalfunctionJan 13, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS HAD A SCRATCH ON THE OPTIC IN THE LOWER RIGHT SIDE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION REVEALED THAT THE ISSUE WAS NOTICED AFTER THE IMPLANTATION OF THE IOL. THERE HAVE BEEN NO COMPLAINTS FROM THE PATIENT RELATED TO THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144171 ↗
• MalfunctionDec 6, 2024Break; Difficult to Fold, Unfold or Collapse; Operating System Becomes Nonfunctional; Break; Difficult to Fold, Unfold or Collapse; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRE-LOADED LENS DID NOT ADVANCE PROPERLY FROM THE INSERTER AND DID NOT UNFOLD CORRECTLY. A NEW JOHNSON & JOHNSON MONOFOCAL LENS WAS IMPLANTED TO REPLACE THE DEFECTIVE PRODUCT. THE LENS HAD A GASH IN THE MIDDLE, WHICH WAS IDENTIFIED WHEN THE IOL UNFOLDED IN THE EYE. SUTURES WERE PLACED AS PART OF THE NORMAL PROCEDURE AND THERE WERE NO COMPLICATIONS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872925 ↗