TECNIS SIMPLICITY DCB00 (REF DCB0000175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 05050474636033), received between Dec 24, 2020 and Sep 18, 2026 — classified as 11 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830239 ↗
• MalfunctionAug 10, 2026Break

  It was reported that a single-piece preloaded monofocal intraocular lens (IOL) was identified as defective. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198636 ↗
• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED WHEN THE SURGEON ATTEMPTED TO ENGAGE IT AND PROCEED WITH THE SURGERY BECAUSE THE VISCOELASTIC DID NOT COVER THE IOL WITHIN THE SIMPLICITY INJECTOR. THE INJECTOR AND IOL WERE ABANDONED, AND THE PROCEDURE WAS COMPLETED WITH A NEW IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670278 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO BOTH THE PATIENT¿S LEFT AND RIGHT EYE. THE PATIENT EXPLAINED THAT HER SYMPTOMS STARTED RIGHT AFTER THE FIRST IMPLANT (RIGHT EYE (B)(6) 2025) BUT THEY WERE NOT AS SEVERE UNTIL THE SECOND EYE WAS DONE BECAUSE NOW, SHE HAS TWO EYES THAT DON¿T WORK. THEY CAN SEE WELL WHEN LOOKING STRAIGHT AHEAD. IF SHE CHANGES HER VIEW SHE SEES WAVES, PRISMS, AND VISION IS BLURRY. THE DEGREE VARIES DEPENDING ON THE LIGHT SHE IS IN. THIS CAUSES HER TO FEEL DIZZY AND AFFECTS HER DEPTH PERCEPTION. PATIENT HAS TROUBLE STANDING, CANNOT DRIVE, IS LOSING HER BALANCE AND FALLING. SHE HAS ACCIDENTALLY CUT HER FINGERS WHEN CUTTING VEGETABLES. REPORTEDLY, HER DOCTOR SAID SHE MAY BE SEEING OUT THE SIDE OF THE LENS. SHE CANNOT SEE THROUGH THE LENS MATERIAL AND INDICATED SHE MAY NEED A DIFFERENT LENS MADE OF A DIFFERENT MATERIAL. PATIENT WAS PRESCRIBED BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION WHICH WAS INITIALLY HELPFUL. HOWEVER, SHE WAS FOUND TO BE ALLERGIC WHICH RESULTED IN DROPPED BLOOD PRESSURE AND EXCESSIVE FATIGUE. SHE HAS DISCONTINUED THIS MEDICATION AND STARTED USING A DIFFERENT EYE DROP. WITH THE EYE DROPS HER VISIO

  Patient problems: Blurred Vision; Flashers; Local Reaction

  MAUDE report 25661705 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO BLURRY VISION. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS INCIDENT. IT WAS INDICATED THAT THE EXPLANTED LENS WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN OR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25355300 ↗
• MalfunctionNov 20, 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 23610227 ↗
• MalfunctionOct 23, 2025Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DCB00, THE CUSTOMER REPORTED THAT THE LEADING HAPTIC OF THE LENS WAS INVERTED, POTENTIALLY CRACKED. THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S EYE. THE PATIENT OUTCOME WAS REPORTED AS TEMPORARILY IMPAIRED AND NO IMPACT ON DAILY ACTIVITIES INDICATED. THE DIRECTION FOR USE WAS FOLLOWED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373207 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE AND THE PATIENT WAS UNHAPPY WITH THE RESULT. THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL BUT WITH A LOWER DIOPTER POWER DURING A SECONDARY SURGICAL PROCEDURE. NO INJURY OR FURTHER INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22756468 ↗
• MalfunctionAug 5, 2025Crack; Crack

  IT WAS REPORTED THAT A PRELOADED LENS WAS IMPLANTED. HOWEVER, UPON THE LENS EMERGING FROM THE INSERTER, THE LENS CARTRIDGE CRACKED ALONG THE LENGTH OF THE CARTRIDGE TUBE. NO INJURY OR INTERVENTION WAS REQUIRED. NO ADDITIONAL MANEUVERS WERE NECESSARY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720061 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) POTENTIALLY HAD A TOXIC ANTERIOR SEGMENT SYNDROME (TASS). NO OTHER SPECIFIC DETAILS WERE PROVIDED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 22527427 ↗
• MalfunctionJun 30, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS HAD A SCRATCH ON ITS SURFACE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366027 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD THE TRAILING HAPTIC OF THE INITIAL IOL CAUGHT IN THE CARTRIDGE AND TORE OFF DURING INSERTION. THE DAMAGED IOL WAS CUT INTO PIECES AND REMOVED WITHOUT COMPLICATIONS OR AN ENLARGED INCISION USING MICRO SCISSORS AND FORCEPS. A NEW LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED WITHOUT INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128397 ↗
• MalfunctionNov 12, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE OUTSIDE SEAL OF MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN. DOCTOR DECIDED HE REQUIRED ANOTHER IOL INSTEAD. THERE WAS NO PATIENT CONTACT. ISSUE WAS OBSERVED UPON OPENING OF PRODUCT PACKAGING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668846 ↗
• MalfunctionOct 29, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT WHEN THE MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) WAS LOADED, THE INJECTOR SLID OVER THE LENS AND DOCTOR WAS NOT HAPPY TO USE THE LENS SO ANOTHER MONOFOCAL PRELOADED IOL WAS USED. AS PER ADDITIONAL INFORMATION RECEIVED, THE LENS LOOKED TO BE CURLED WITH A LEADING HAPTIC. THE ISSUE OCCURRED PRIOR TO INSERTION. THERE WAS NO ANY PATIENT INJURY. THE PATIENT HAD MADE A FULL RECOVERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562015 ↗
• MalfunctionAug 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A TEAR IN THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE ISSUE OCCURRED WHEN INSERTING AND THE HAPTIC AND OPTIC WERE IN CONTACT WITH THE EYE. IT IS UNKNOWN IF THE LENS WAS FULLY OR PARTIALLY INSERTED. THERE WAS A DELAY IN PROCEDURE BY 20 MINUTES. SUTURES WERE NEEDED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING FINE. THE LENS WAS NOT STUCK IN THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015006 ↗
• MalfunctionJun 6, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THE PRE-LOADED DCB00 MODEL CARTRIDGE WAS PREMATURELY OPENED DURING INSERTION. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL DEPLOYED UNEXPECTEDLY AND THE IOL WAS UNLOADED FROM THE CARTRIDGE WHEN INSERTING INTO THE EYE. THE INTRAOCULAR LENS (IOL) WAS NOT FULLY INSERTED INTO THE PATIENT'S EYE. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED USING A BACK-UP DCB00 17.5 DIOPTER IOL THAT WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS WITHIN NORMAL LIMITS (WNL). 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 19481003 ↗
• MalfunctionMay 17, 2024Break; Crack; Device Difficult to Setup or Prepare; Mechanical Jam; Break; Crack; Device Difficult to Setup or Prepare; Mechanical Jam

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE INJECTOR HAD SOME RESISTANCE WHEN THEY WANTED TO PUSH AND DETERMINED THAT THE LENS WAS STUCK IN THE CARTRIDGE/INJECTOR. ADDITIONAL INFORMATION WAS PROVIDED REPORTING AT THE TIME OF DEPLOYMENT, THERE WAS RESISTANCE IN THE INJECTOR, SO THE DOCTOR DECIDED NOT TO IMPLANT IT. A PHOTO WAS PROVIDED AND SHOWS THAT THE TIP OF THE CARTRIDGE DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347327 ↗
• MalfunctionMay 17, 2024Break; Mechanical Problem; Device Difficult to Setup or Prepare; Ejection Problem; Break; Mechanical Problem; Device Difficult to Setup or Prepare; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) MISFIRED AFTER THE SURGEON NOTED THE APPLICATOR TO BE TIGHT. THE LENS WENT INTO THE PATIENT EYE BUT WAS FOUND TO BE "DOUBLE FOLDED" / DAMAGED AND WAS REMOVED. POST PROCEDURE THE SURGEON EXAMINED THE DEVICE UNDER A MICROSCOPE AND FOUND THE INSERTER HAD ADVANCED OVER THE IOL. THROUGH FOLLOW UP WE LEARNED THAT THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WHICH CAUSED A NON SIGNIFICANT DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345157 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED UPON INSERTION THE DCB00 MODEL INTRAOCULAR LENS (IOL) WAS DAMAGED BY THE LOADER/PLUNGER. THE IOL WAS REMOVED FROM THE PATIENT AND THE BACK-UP IOL WAS INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO MEDICAL AND/OR SURGICAL INTERVENTION. PATIENT STATUS POST-OPERATIVELY WAS REPORTED AS NO COMPLICATIONS. BALANCED SALT SOLUTION (BSS) WAS USED AT ROOM TEMPERATURE. AFTER INSERTER PREPARATION THERE WERE NO SURGERY DELAYS BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509181 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC. IT WAS NOTED THAT EVENT OCCURRED DURING HANDLING PRIOR TO INSERTION, THERE WAS NO PATIENT CONTACT. THE SURGERY WAS SUCCESSFULLY COMPLETED USING THE BACK-UP LENS. SUSPECT PRODUCT WAS DESTROYED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436621 ↗
• InjuryJul 28, 2023Mechanical Jam; Mechanical Jam

  IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT ADVANCE OUT OF SHOOTER INTO THE EYE OF PATIENT. THE CARTRIDGE TIP WAS IN CONTACT WITH EYE. THE LENS WAS NEVER IMPLANTED. THE EVENT WAS NOT REPORTABLE AT THAT TIME. RECEIVED A VOLUNTARY REPORT WITH ADDITIONAL INFORMATION RECEIVED BY HEALTH CANADA, THAT THE SURGEON PERFORMED A POSTERIOR VITRECTOMY WITH IOL IMPLANT. ANOTHER LENS WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419534 ↗
• MalfunctionJul 28, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A 0.1MM TO 0.2MM SCRATCH ON THE OPTIC WHEN IT WAS INSERTED INTO THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414256 ↗
• MalfunctionJun 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS RECEIVED WITH AN HAPTIC DETACHED. THROUGH FOLLOW UP WE LEARNED THAT THE SURGEON BELIEVES THAT THE HAPTIC PROBABLY DETACHED DURING THE LOADING (PRELOADED IOL) BECAUSE THEY NOTICED SOMETHING WAS WRONG DURING IMPLANTATION. THE SURGEON DECIDED NOT TO IMPLANT THAT IOL. WHEN THE IOL WAS TAKEN OUT ONTO THE OPERATING TABLE THE HAPTICS APPEARED DETACHED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114445 ↗
• MalfunctionJun 9, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) WERE BENT AND THAT THE IOL PLATE HAS A CUT IN THE MIDDLE OF THE OPTICS. THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101081 ↗
• MalfunctionJun 2, 2023Difficult to Fold, Unfold or Collapse; Material Fragmentation; Difficult to Fold, Unfold or Collapse; Material Fragmentation

  IT WAS REPORTED WHEN INSERTING THE INTRAOCULAR LENS ( IOL), THE TRAILING HAPTIC WAS STUCK IN THE CARTRIDGE. THE SURGEON TRIED TO NUDGE THE HAPTIC LOOSE WITH A SINSKEY HOOK, FOLLOWED BY A MICROGRASPER, BUT THE TIP OF THE HAPTIC REMAINED STUCK AND ACTUALLY BROKE OFF, WITH THE BROKEN BIT REMAINING IN THE TIP OF THE CARTRIDGE. THE IOL WAS SITTING IN GOOD POSITION AND THE SURGEON OPTED TO LEAVE IT IMPLANTED AS IS, AT THE TIME OF SURGERY. THE CARTRIDGE WAS FULLY FILLED WITH BALANCED SALINE SOLUTION AT THE TIME FOR IMPLANTATION. THROUGH FOLLOW UP IT WAS LEARNED THAT THE SURGEON DECIDED TO LEAVE THE IOL AS HE USED MIOSTAT TO CONSTRICT THE PUPIL AND CLOSE THE INCISION IN THE USUAL MANNER AS PART OF STANDARD OF CARE. THERE WAS A FIVE MINUTE DELAY. IT IS UNKNOWN IF THE PATIENT WILL REQUIRE AN EXPLANT OR NOT. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056506 ↗