TECNIS SIMPLICITY DCB00 (REF DCB0000200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 05050474636088), received between Jan 8, 2021 and Sep 24, 2026 — classified as 16 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  Patient problems: Prolapse

  MAUDE report 50892479 ↗
• MalfunctionAug 24, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408962 ↗
• MalfunctionAug 21, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383041 ↗
• MalfunctionJul 10, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787823 ↗
• MalfunctionJun 9, 2026Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS HAD BEEN LOADED UPSIDE DOWN IN THE INJECTOR. THE SURGEON MANAGED TO USE THE LENS BUT HAD TO INSERT IT MANUALLY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446315 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT THE SURGEON OBSERVED A DEEP MARK/SCRATCH ON THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) POST IMPLANTATION AFTER THE IOL HAD UNFOLDED. THE SURGEON DECIDED TO LEAVE THE IOL IN PLACE RATHER THAN REMOVING THE DEVICE DUE TO CONCERNS REGARDING FURTHER PATIENT RISK. THE IOL WAS POSITIONED SO THE MARK/SCRATCH WOULD NOT AFFECT THE PATIENT'S VISUAL OUTCOME. THERE WAS NO PATIENT INJURY AND NO INTERVENTIONS WERE REPORTED. THE PATIENT WAS INFORMED OF THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225230 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL IMPLANTATION OF PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS). POSTOPERATIVELY, THE PATIENT EXPERIENCED POOR ADAPTATION TO BLENDED VISION, AND THE IOLS WERE EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE ON THE SAME DAY. NO INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURAL DELAY WERE REPORTED. THE PATIENT¿S CONDITION WAS TEMPORARILY IMPAIRED, WITH AN IMPACT ON ACTIVITIES OF DAILY LIVING, SUCH AS READING. BEST-CORRECTED VISUAL ACUITY WAS 20/20 IN BOTH EYES PREOPERATIVELY AND POSTOPERATIVELY. THE DIRECTIONS FOR USE WERE FOLLOWED, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 25035342 ↗
• MalfunctionApr 27, 2026Break; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, WAS DEFECTIVE, DROPPED, OR MISFIRED DURING THE SURGICAL PROCEDURE. NO PATIENT CONTACT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE ISSUE WAS REPORTED WITH FOUR LENSES; THIS REPORT PERTAINS TO ONE OF THE FOUR LENSES. SEPARATE REPORTS HAVE BEEN SUBMITTED ON THE OTHER THREE LENSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002402 ↗
• MalfunctionJan 13, 2026Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED WHEN A SCRATCH WAS OBSERVED AT THE HAPTIC OPTIC JUNCTION. IT WAS ALSO REPORTED THE LENS WAS EXPLANTED. THE PATIENT'S CURRENT STATUS IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059831 ↗
• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE MONOFOCAL, PRELOADED, INTRAOCULAR LENS (IOL) THE TIP OF THE INJECTOR DEVELOPED A TEAR. NO PATIENT INJURY WAS REPORTED. NO INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970561 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FOUND TO BE BROKEN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855898 ↗
• MalfunctionDec 16, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN; THEREFORE, THE IENS WAS NOT IMPLANTED. THROUGH FOLLOW-UP, WE LEARNED THAT WHEN THEY TRIED TO LOAD THE IOL INTO THE INJECTOR, THE LENS SHIFTED TO ONE SIDE AND BECAME STUCK. THE SURGEON MANAGED TO REMOVE THE LENS AND DISCOVERED THAT IT WAS CRACKED. THIS OCCURRED DURING THE PRE-SURGERY PREPARATION. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824744 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON NOTED THE IOL HAD A CRACK THROUGH THE CENTER OF THE OCULAR SURFACE. THE IOL WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A BACKUP LENS. THERE WAS NO REPORT OF PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578020 ↗
• MalfunctionNov 7, 2025Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTICS STUCK TOGETHER INSIDE THE EYE. THE SURGEON EMPLOYED A SECOND INSTRUMENT TO SEPARATE THE HAPTICS, WHICH CAUSED A DELAY OF APPROXIMATELY ONE MINUTE. THE PATIENT¿S STATUS WAS UNKNOWN, AND DAILY ACTIVITIES WERE NOT AFFECTED. THE INCISION WAS NOT ENLARGED, A VITRECTOMY WAS NOT PERFORMED, AND NO MEDICATIONS WERE ADMINISTERED. THE PATIENT DID NOT SEEK MEDICAL ATTENTION, AND IT IS UNCLEAR WHETHER SUTURES WERE REQUIRED. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500947 ↗
• MalfunctionNov 3, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON OBSERVED THE HAPTIC TO BE DAMAGED. THE IOL WAS DISCARDED AND THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WAS A 5 MINUTE DELAY WHILE THE NEW DEVICE WAS BEING PREPARED. THROUGH FOLLOW UP, WE LEARNED THAT THE PLUNGER HAD PASSED OVER THE IOL, POTENTIALLY CAUSING THE LENS AND HAPTIC DAMAGE. THIS ISSUE WAS FOUND PRIOR TO PATIENT CONTACT. NO PATIENT INJURY WAS REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459076 ↗
• MalfunctionOct 31, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439860 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT POST IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE SURGEON NOTED THE IOL HAD A DEFECT ON ONE EDGE. THROUGH FOLLOW UP, WE LEARNED THAT THE IOL REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432687 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IDENTIFIED WITH AN ISSUE DURING A PROCEDURE. WHEN EJECTING THE LENS WITH THE SIMPLICITY INJECTOR, IT WAS NOTED THAT THE LEADING HAPTIC WAS DEFORMED. AS A RESULT, THE LENS WAS NOT COMPLETELY INSERTED INTO THE PATIENT'S EYE. NO HARM WAS CAUSED TO THE PATIENT. THE SIMPLICITY INJECTOR WAS REMOVED, A REPLACEMENT LENS WAS REQUESTED, AND THE AFFECTED LENS WAS DISPOSED OF IN THE TRASH. IT WAS NOTED THAT THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999911 ↗
• InjuryAug 1, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  VISCOELASTIC WAS INJECTED INTO THE CAPSULAR BAG AND THE DCB00 MODEL INTRAOCULAR LENS (IOL) IMPLANT WAS INJECTED. THE IOL WAS DIFFICULT TO ROTATE INTO THE CAPSULAR BAG AND VITREOUS WAS SUSPECTED. THE IOL WAS ELEVATED OUT OF THE CAPSULAR BAG AND PLACED GENTLY ONTO THE IRIS. SUPERIOR SUBCONJUNCTIVAL LIDOCAINE 2% WITHOUT EPINEPHERINE WAS INJECTED AND A 23G TROCAR WAS PLACED IN THE SUPEROTEMPERAL QUADRANT APPROXIMATELY 4 MM FROM THE LIMBUS. ANTERIOR VITRECTOMY WAS PERFORMED. THE ANTERIOR CHAMBER WAS REFILLED WITH VISCOELASTIC AND THE IOL WAS TRISECTED WITH INTRAOCULAR SCISSORS AND REMOVED. THE INCISION WAS SLIGHTLY ENLARGED AND A 3 PIECE INTRAOCULAR LENS WAS PLACED INTO THE CILIARY SULCUS AND THE OPTIC CAPTURED. THE TEMPORAL INCISION WAS CLOSED WITH 10-0 NYLON IN A FIGURE-OF-EIGHT CONFIGURATION. THE KNOT WAS CUT, ROTATED, AND BURIED. ANTERIOR VITRECTOMY WAS PERFORMED WITHIN THE ANTERIOR CHAMBER TO ENSURE NO VITREOUS WAS PRESENT. AN INFERONASAL IRIDOTOMY WAS CREATED. ALL WOUNDS WERE IRRIGATED AND 10-0 NYLON WAS USED TO SECURE THE SUPERIOR AND INFERIOR PARACENTESIS INCISIONS. THE KNOTS WERE CUT, ROTATED, AND BURIED. THE WOUNDS WERE RECHECKED AND FOUND TO BE WATERTIGHT. MIOCHOL AND MOXIFLO

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

  MAUDE report 22688398 ↗
• MalfunctionJul 14, 2025Break; Failure to Fold; Mechanical Jam; Break; Failure to Fold; Mechanical Jam

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE LENS STOPPED ADVANCING AND WAS STUCK IN THE CARTRIDGE. IT WAS REPORTED AS AN UNFOLDING ISSUE. THE SURGEON FELT A "POP," DESCRIBING IT AS THE "CARTRIDGE EXPLODED." IT WAS REPORTED THE LENS WAS PARTIALLY INSERTED AND LENS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE INJECTOR WAS REMOVED, AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT WITHOUT FURTHER INCIDENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT HAS FULLY RECOVERED WITHOUT ANY REPORTED IMPAIRMENTS. FURTHER CLARIFICATION WAS PROVIDED THAT THE LENS WAS PARTIALLY INSERTED AS IT EXTENDED PAST THE TIP OF THE INSERTER. IT WAS THEN ALL REMOVED WHEN THERE WAS THE ¿POP¿. THE LENS WAS NOT FULLY DEPLOYED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502975 ↗
• MalfunctionJun 30, 2025Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS A THREAD ON THE PRELOADED INTRAOCULAR LENS (IOL). THE LENS WAS IMPLANTED. THE THREAD COULD NOT BE SUCTIONED OFF. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367810 ↗
• MalfunctionJun 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IS PLANNED FOR EXPLANT FROM PATIENT'S LEFT EYE DUE TO PARTIAL DISLOCATION OF THE INTRAOCULAR LENS INTO THE ANTERIOR CHAMBER, SPECIFICALLY INVOLVING THE NASAL HAPTIC. AS A RESULT OF THIS CONDITION, THE PATIENT HAS BEEN EXPERIENCING BLURRY VISION, FOGGY VISION, AND DOUBLE VISION. NO FURTHER INFORMATION HAS BEN RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 22324558 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS REPORTED REGARDING A MONOFOCAL INTRAOCULAR LENS (IOL) INVOLVING A PATIENT WHO UNDERWENT A PROCEDURE ON HIS RIGHT EYE (OD). THE LENS AND CARTRIDGE BOTH CAME INTO CONTACT WITH THE PATIENT'S EYE. DURING THE PROCEDURE, THE LENS WENT THROUGH THE BAG OF THE PATIENT¿S EYE AND WAS SUBSEQUENTLY REMOVED IN THE SAME PROCEDURE. THE PROCEDURE WAS NOT COMPLETED. IT WAS INDICATED THAT A VITRECTOMY WAS PERFORMED. THE IOL WAS DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22302167 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  THE SURGEON REPORTED THAT UNDER THE MICROSCOPE AFTER IMPLANTATION IT WAS NOTICED THE PRE-LOADED LENS HAD SCUFFING AT THE 7 O'CLOCK AND 1 O'CLOCK. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207752 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS "NOT QUITE RIGHT, DEFECTIVE". THERE WAS PATIENT CONTACT WITH THE DEVICE BUT THE IOL WAS NOT FULLY INSERTED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED WITH A BACK UP IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154825 ↗