TECNIS SIMPLICITY DCB00 (REF DCB0000235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 05050474636156), received between Mar 24, 2021 and Sep 30, 2026 — classified as 16 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 75 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Crack

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

  MAUDE report 50948539 ↗
• MalfunctionAug 27, 2026Physical Resistance/Sticking

  It was reported that, following implantation of the intraocular lens, the haptic remained stuck and did not unfold as intended. No treatment delay occurred, and no additional interventions were required. Similar events have been reported previously. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475774 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, IN THE PATIENT¿S RIGHT EYE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25352652 ↗
• MalfunctionApr 22, 2026Ejection Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL), THE INJECTOR TIP DID NOT ACHIEVE PROPER INSERTION, RESULTING IN THE IOL NOT BEING SUCCESSFULLY DELIVERED. THE EVENT OCCURRED DURING THE IMPLANTATION/APPLICATION PHASE OF THE PROCEDURE. A SECONDARY SURGICAL INSTRUMENT WAS USED TO REMOVE THE INJECTOR FROM THE WOUND. THE IOL WAS DISCARDED AS IT WAS NOT FULLY INJECTED INTO THE PATIENT¿S EYE. NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING A BACKUP IOL OF THE SAME MODEL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958660 ↗
• MalfunctionMar 13, 2026Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED DURING INSERTION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591711 ↗
• MalfunctionDec 29, 2025Crack; Device Difficult to Setup or Prepare; Mechanical Jam; Crack; Device Difficult to Setup or Prepare; Mechanical Jam

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, RESISTANCE WAS FELT WHILE ADVANCING AND IT WAS NOTICED THAT THE LENS AND PLUNGER HAD BROKEN THROUGH THE SIDE OF THE CARTRIDGE. THE LENS WAS STUCK IN CARTRIDGE AND WOULD NOT ADVANCE. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION AND THERE WAS PATIENT CONTACT WITH THE TIP OF THE CARTRIDGE. THE LENS WAS CHANGED TO ANOTHER IOL WITH THE SAME MODEL AND DIOPTER. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR DELAY IN PROCEDURE. THERE WERE NO ACTIVITIES THAT THE PATIENT COULD NOT PERFORM DUE TO THIS ISSUE, AND THE PATIENT DID NOT SEEK MEDICAL INTERVENTION OR HAVE MEDICATION PRESCRIBED OUTSIDE OF THE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT IT WAS NOTICED THAT THE CARTRIDGE TIP WAS BROKEN. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907050 ↗
• MalfunctionNov 20, 2025Scratched Material; Scratched Material

  IT WAS REPORTED AFTER THE LENS WAS IMPLANTED AND POSITIONED INSIDE THE EYE, A NOTICEABLE SCRATCH WAS FOUND AT THE MIDDLE PART OF THE LENS OPTIC. THE SURGICAL PROCEDURE WAS COMPLETE WITH LENS IMPLANTED. THE LENS IMPLANTATION WAS SMOOTH WITH NO OBSTRUCTION. HOWEVER, THE SCRATCH REMAINED CLEAR AND NOTICEABLE AFTER THE VISCOELASTIC WAS REMOVED. PATIENT'S FEEDBACK WAS HIS VISION WAS NOT CLEAR ENOUGH BUT HAD NO OTHER DISCOMFORT. THE LENS REMAINED IMPLANTED IN THE PATIENT'S EYE. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. BASED ON FOLLOW-UP INFORMATION RECEIVED ON 11/5/2025, THE COMPLAINT REPORTER CONFIRMED THAT LENS REMAINED IMPLANTED IN THE PATIENT'S EYE AND HE HAD SLIGHT BLURRY VISION BUT NO DISCOMFORT.

  Patient problems: Blurred Vision

  MAUDE report 23606214 ↗
• MalfunctionNov 14, 2025Crack; Crack

  DURING INSERTION, THE CARTRIDGE OF THE DCB00 MODEL INTRAOCULAR LENS (IOL) CRACKED WHILE TRYING TO INSERT IT INTO THE PATIENT'S EYE AND THERE WAS PATIENT CONTACT. THERE WAS NO PATIENT INJURY AND NO MEDICATIONS WERE PRESCRIBED; HOWEVER, A SUTURE WAS REQUIRED AS A SURGICAL INTERVENTION. THE PATIENT HAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE FOLLOWING WERE UNKNOWN: EXTENT OF PATIENT CONTACT, WHETHER THE CARTRIDGE TIP DAMAGED, AND IF ANY ADDITIONAL MANEUVERS WERE NECESSARY. A BACK-UP IOL WAS NOT IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560293 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED AN EXPLANT DUE TO THE DETECTION OF CANDIDA GLABRATA COLONIES IN THE CAPSULAR BAG LOCATED BEHIND THE LENS. THE PATIENT, WHO HAD PREVIOUSLY UNDERGONE A CORNEAL TRANSPLANT THAT REMAINED CLEAR, BEGAN EXHIBITING WHITE INFILTRATES IN THE CAPSULAR BAG AND WHAT APPEARED TO BE CORTEX ONE MONTH AFTER THE SURGERY. A CULTURE OBTAINED DURING A FOLLOW-UP PROCEDURE CONFIRMED THE PRESENCE OF CANDIDA GLABRATA. THE INTRAOCULAR LENS AND CAPSULAR BAG WERE REMOVED, WHICH LED TO A REDUCTION IN INFLAMMATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Endophthalmitis

  MAUDE report 23398158 ↗
• MalfunctionSep 17, 2025Mechanical Problem; Scratched Material; Mechanical Problem; Scratched Material

  IT WAS REPORTED BY THE CUSTOMER THAT PRELOADED INTRAOCULAR LENS WAS IDENTIFIED AS FAULTY DUE TO MARKS ON THE LENS AND LOADING MARKS. THERE WAS NO CONTACT WITH THE PATIENT¿S EYE, AND NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077420 ↗
• MalfunctionJul 31, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS CAME SCRATCHED AND DOCTOR COULDN'T TELL UNTIL IT WAS DEPLOYED INTO THE PATIENTS EYE. LENS WAS FULLY INSERTED AND REMOVED IN THE SAME PROCEDURE. IT WAS REPLACED WITH ANOTHER SAME MODEL AND DIOPTER LENS. PATIENTS DAILY ACTIVITIES WERE NOT AFFECTED. VITRECTOMY WAS NOT REQUIRED. THERE WAS 5 MINS DELAY IN PROCEDURE. THE DIRECTIONS FOR USE WERE FOLLOWED AND THERE WAS NO ERROR THAT LEAD TO THE EVENT. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680084 ↗
• InjuryJul 24, 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). POST-OPERATIVELY, PATIENT IS REPORTING BLURRY VISION, LIKE A FOG, AND BLACK DOTS, WHICH ARE AFFECTING HER ABILITY TO DRIVE AND VIEWING FAR AWAY, AS WELL AS CAUSING DIFFICULTY WITH READING. HER VISION HAS BEEN GREAT UP TO ABOUT A YEAR AGO. PATIENT'S PRIMARY DOCTOR INSTRUCTED HER TO BOOK AN APPOINTMENT TO HAVE A ONE (01) MINUTE LASER PROCEDURE TO "CLEAN THINGS UP." NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22601740 ↗
• MalfunctionJun 16, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PATIENT HAD SENILE CATARACTS. DURING THE OPERATION, SCRATCHES WERE DISCOVERED ON THE OPTICAL AREA OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS, WHICH WAS SUBSEQUENTLY REMOVED AND REPLACED WITHOUT CAUSING ANY ADVERSE EFFECTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215689 ↗
• MalfunctionJun 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS POLLUTED AND NOT IMPLANTED. THE PACKAGING WAS OPEN, BUT THE BOX WAS INTACT. THROUGH FOLLOW-UP, WE LEARNED THAT THIS DAMAGE WAS NOT CAUSED BY TRANSPORT, AS THE OPERATING ROOM INDICATED THAT THE BOX WAS INTACT AND THAT ONLY THE LENS CASING WAS OPEN. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146551 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A DEFECT. THE SURGEON NOTED OBSERVING A SCRATCH IN THE CENTER OF THE LENS AFTER IMPLANTATION. THE PATIENT'S DAILY ACTIVITIES WERE NOT AFFECTED, AND THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128530 ↗
• InjuryMay 5, 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 IMPLANTED IN PATIENT'S RIGHT EYE. THE PATIENT EXPERIENCED A SIGNIFICANT LOSS OF VISION IN THE RIGHT EYE FOLLOWING SURGERY AND REPORTED ALMOST BLIND IN THAT EYE. POST-SURGERY, THE PATIENT COMPLAINED OF SEEING SHADOWS AND HAS FACED SEVERE PAIN AND SUPER DRY EYES. THE PATIENT WAS TOLD TO USE EYE DROPS AND APPLY AN OINTMENT FOR PAIN AND IT HELPED A LITTLE BIT. DESPITE COMPLAINTS REGARDING VISION IMPAIRMENT AND ONGOING PAIN WITH THE SURGEON, NO FOLLOW-UP HAS OCCURRED FROM THE TREATING PHYSICIAN. THIS CONDITION HAS SEVERELY IMPACTED THE PATIENT¿S ABILITY TO PERFORM DAILY ACTIVITIES, BUT DID NOT SPECIFY WHAT ACTIVITY WAS IMPACTED. NO FURTHER INFORMATION WAS RECEIVED.

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

  MAUDE report 21964597 ↗
• MalfunctionApr 30, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING CATARACT COMBINED WITH MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) IMPLANTATION UNDER TOPICAL ANESTHESIA, SCRATCHES WERE FOUND ON THE OPTICAL SURFACE OF THE LENS, WHICH AFFECTED ITS USE. THE USE WAS IMMEDIATELY STOPPED AND LENS WAS REPLACED WITH LENS OF THE SAME MODEL AND POWER. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937686 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE SEVERER DYSPHOTOPSIA NOT TOLERATED BY PATIENT. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE WAS PATIENT INJURY. THERE WAS INCISION ENLARGED. THE PATIENT IS DOING WELL WITH VISION POST OPERATIVE AS 20/25. NO INFORMATION IS AVAILABLE.

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

  MAUDE report 21909011 ↗
• MalfunctionApr 22, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PLUNGER IN THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) DID NOT FUNCTION AS EXPECTED, RESULTING IN THE LENS BEING PIERCED. CONSEQUENTLY, THE DEVICE WAS DISCARDED, AND A SECOND DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT ANY DELAY TO THE SURGERY. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AND THUS, NO PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886538 ↗
• MalfunctionFeb 25, 2025Material Fragmentation; Material Fragmentation

  THE PRE-LOADED DCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED FROM THE PATIENT'S EYE THE DUE TO A SHEARED OFF HAPTIC UPON IMPLANTATION. IT IS UNKNOWN IF ANOTHER IOL WAS IMPLANTED DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464661 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT HAPTIC WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370630 ↗
• MalfunctionJan 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON THE SAME DATE, THERE WERE ISSUES WITH THREE DIFFERENT PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), USED IN THREE PATIENTS. THE ISSUES WERE IDENTIFIED POST-IMPLANTATION AND NONE OF THE IOLS WERE EXPLANTED. THERE WAS NO INDICATION OF PATIENT IMPAIRMENT. IT IS UNKNOWN IF THE PATIENTS' DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. NO OTHER SURGERIES ON THE SAME DATE REPORTED ISSUES. WE LEARNED THROUGH FOLLOW UP THAT PATIENTS ARE OKAY, AND THERE ARE NO PLANS TO EXPLANT THE LENS. THIS REPORT IS FOR THE LENS IDENTIFIED AS IOL 1 WITH ISSUE PROVIDED AS MARKING OR TEAR WAS OBSERVED NEAR THE OPTIC-HAPTIC JUNCTION AFTER IMPLANTATION IN THE RIGHT EYE (OD). NO FURTHER INFORMATION WAS PROVIDED. SEPARATE REPORTS WILL BE SUBMITTED FOR EACH OF THE DEVICES (IOL 1, IOL 2, IOL 3) CAPTURED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270390 ↗
• MalfunctionJan 10, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FAILED TO DEPLOY. THROUGH FOLLOW UP WE LEARNED THAT WHILE THE SURGEON HAD THE INJECTOR TIP IN THE PATIENT'S EYE INCISION, THE TRAILING HAPTIC WAS STUCK IN THE INJECTOR. THE SURGEON INJECTED MORE VISCOELASTIC INTO THE TIP OF THE DEVICE AND BY USING A SINSKEY HOOK AND MOVING THE INJECTOR SCREW GENTLY BACK AND FORTH, MANAGED TO FREE THE TRAILING HAPTIC. THE SURGEON THEN HAD TO MANUALLY MANIPULATE THE IOL INTO THE CORRECT POSITION. THE SURGEON NOTES THAT HE DID NOT WITHDRAW THE IOL DUE TO CONCERNS ABOUT DAMAGING THE ZONULE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129617 ↗
• MalfunctionNov 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD THE HAPTICS STICKING ON THE SIDE OF THE LENS OPTICS. THE SURGEON HAD TO MANIPULATE THE LENS IN THE PATIENT'S LEFT EYE. THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO VITRECTOMY PERFORMED AND NO INCISION ENLARGED WAS REQUIRED. NO MEDICAL INTERVENTION WAS REQUIRED OUTSIDE OF THE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730227 ↗
• MalfunctionNov 5, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) WAS USED AND AS A PRELOADED IOL IT WAS NOT TEMPERED WITH UNTIL IT WAS INSERTED INTO THE EYE. UPON PUSHING THE LENS THROUGH THE SHOOTER, THERE WERE NO ANY VISIBLE MARKS OR SCRATCHES ON THE LENS. WHEN THE LENS WAS UNFOLDED UNDER THE MICROSCOPE, TWO SCRATCHES WERE VISIBLE. THE SURGEON DID NOT REMOVE THE LENS HOWEVER SURGEON WAS NOT IMPRESSED THAT THE PRELOADED LENS WAS ALREADY SCRATCHED. IOL STILL REMAINS IMPLANTED. REVIEW 24 HOURS POST OPERATIVELY IN EYE OUT PATIENT DEPARTMENT.(OPD) REVEALED THAT THE IOL WAS PERFORMING AS EXPECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606575 ↗