TECNIS SIMPLICITY DIB00 (REF DIB00U0185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 05050474731721), received between Mar 31, 2021 and May 26, 2026 — classified as 11 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) GOT STUCK IN THE EYE INCISION. THE DOCTOR HAD TO USE 0.12 FORCEPS TO PULL THE IOL. IT WAS DECIDED TO USE ANOTHER LENS. THE CUSTOMER DISCARDED THE IOL AS THEY FELT THERE WAS NOTHING WRONG WITH IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291480 ↗
• MalfunctionNov 14, 2025Difficult to Fold, Unfold or Collapse; Device Dislodged or Dislocated; Physical Resistance/Sticking; Difficult to Fold, Unfold or Collapse; Device Dislodged or Dislocated; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTICS WERE STICKING TO THE EDGE OF THE OPTIC AND A SURGICAL TOOL WAS NEEDED TO SEPARATE THE HAPTICS. ONE OF THE HAPTICS DID NOT FOLD OUT PROPERLY, WAS STILL FOLDED OR WAS NOT FULLY DEPLOYED/UNFOLDED. THEREFORE, THE LENS DID NOT POSITION PROPERLY IN THE PATIENT'S EYE. THE PATIENT REPORTED VISION IS GOOD, 20/25, BUT OCCASIONALLY SEES A LINE, WHEN LOOKING INTO BRIGHT LIGHTS. THE PATIENT IS NOT VERY BOTHERED. HOWEVER, THE IOL EXCHANGE WAS PLANNED FOR (B)(6) 2025. THE PROCEDURE INVOLVED A 10-MINUTE DELAY. THROUGH FOLLOW UP, IT WAS LEARNED THE IOL EXCHANGE WAS PERFORMED ON (B)(6) 2025. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23560011 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE PATIENT WAS STRUGGLING WITH POSITIVE DYSPHOTOPSIA IN THE LEFT EYE. THE ISSUE WAS FIRST IDENTIFIED IN POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A 3-PIECE MONOFOCAL IOL IN THE SULCUS. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, HOWEVER, UNPLANNED SUTURES WERE REQUIRED. A PLANNED VITRECTOMY WAS ALSO REQUIRED. THERE WAS NO DELAY IN PROCEDURE. IT IS UNKNOWN IF MEDICAL ATTENTION OR MEDICATION (OUTSIDE THE STANDARD OF CARE) WAS REQUIRED. THE DIRECTIONS FOR USE WAS FOLLOWED. THE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) IMPROVED FROM 20/40 PRE-OPERATIVELY TO 20/20 POST-OPERATIVELY. THE PATIENT WAS ABLE TO PERFORM DAILY ACTIVITIES. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers

  MAUDE report 23500411 ↗
• MalfunctionOct 27, 2025Material Fragmentation; Material Fragmentation

  AFTER IMPLANTING THE DIB00 MODEL INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE), THE SURGEON REPORTED THE TRAILING HAPTIC WAS MISSING. WHEN REMOVING THE IOL, THE DOCTOR HAD ISSUES CUTTING THE LENS AND THE INCISION WAS ENLARGED. THERE WAS A PROCEDURAL DELAY OF TWENTY (20) MINUTES; HOWEVER, THERE WAS NO SUTURES AND NO VITRECTOMY. PATIENT STATUS POST PROCEDURE WAS REPORTED AS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 23398250 ↗
• MalfunctionSep 17, 2025Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE SPLIT AT THE END DURING THE INSERTION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS. THE LENS WAS PARTIALLY INSERTED AND SUBSEQUENTLY REPLACED WITH THE SAME MODEL AND DIOPTER LENS. THERE WERE NO REPORTS OF PATIENT INJURY OR THE NEED FOR MEDICAL OR SURGICAL INTERVENTIONS. THE PATIENT OUTCOME WAS FINE. THE PRODUCT IS BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075214 ↗
• InjuryAug 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. THE REASON FOR THE EXPLANT IS THE PATIENT WAS EXPERIENCING EXTREMELY BAD GLARE THAT WAS DEBILITATING. THE REPLACEMENT IOL WAS A NON-JOHNSON & JOHNSON IOL, ALCON MA60AC AND A VITRECTOMY WAS PERFORMED DURING THE PROCEDURE. THE PATIENT WAS REPORTED AS DOING OKAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22881553 ↗
• MalfunctionJun 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A PLAQUE ON THE BACK OF THE LENS WHICH WAS THOUGHT TO BE VISCOELASTIC OR THAT WHITE STUFF THAT CAME OUT OF THE INJECTOR. AS IT WAS TOO CENTRAL TO THE LENS IT WAS DIFFICULT TO GET IT OFF OF THE IRRIGATION & ASPIRATION. THE NEXT DAY IT WAS DISSOLVED. IT DIDN¿T LOOK LIKE A SCRATCH OR A SCUFF. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285690 ↗
• MalfunctionMar 25, 2025Material Fragmentation; Material Fragmentation

  THE INITIAL REPORT INDICATED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE DUE TO A COMPLICATION DURING ITS DELIVERY. SPECIFICALLY, THE TRAILING HAPTIC WAS TORN OFF, WHICH NECESSITATED THE REMOVAL OF THE LENS. SUBSEQUENT FOLLOW-UPS REVEALED THAT UPON INSERTION OF THE LENS INTO THE PATIENT'S LEFT EYE, IT UNFOLDED AND BENT UPWARD AT A 90-DEGREE ANGLE, RESULTING IN THE TRAILING HAPTIC BEING AMPUTATED BY THE INJECTOR. THE SURGICAL WOUND WAS ENLARGED, AND THE LENS WAS CUT AND REMOVED FROM THE EYE. A REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED; HOWEVER, DETAILS ABOUT THE MODEL AND DIOPTER OF THE REPLACEMENT LENS WERE NOT PROVIDED. ONE DAY POST-OPERATION, THE PATIENT WAS REPORTED TO HAVE CORNEAL EDEMA. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 21690224 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PRELOADED INTRAOCULAR LENS (IOL) SURGERY IN LEFT EYE ON (B)(6) 2024. POST OP PATIENT REPORTED NOT BEING HAPPY WITH THE IMPLANT DUE TO BLURRY VISION AND WANTED IT REMOVED. THE VISION PREOPERATIVE WAS: 20/30 AND THE VISION POST OPERATIVE WAS: 20/20-1. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE ON (B)(6) 2025 AND REPLACED WITH A DRN00V LENS WITH 18.5 DIOPTER. THE PATIENT FEELS BETTER WITH THE REPLACED LENS. THERE WERE NO ANY DEBILITATING CONDITIONS AND PATIENT HAD FULLY RECOVERED.

  Patient problems: Blurred Vision

  MAUDE report 21543013 ↗
• MalfunctionFeb 12, 2025Break; Failure to Advance; Break; Failure to Advance

  DURING IMPLANTATION OF THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) THE SURGICAL TECHNICIAN EXPERIENCED A LOADING ISSUE AND THE HAPTIC WAS BROKEN; THE LENS WAS PARTIALLY INSERTED. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE INITIAL PROCEDURE. IT IS UNKNOWN IF MEDICATION WAS PRESCRIBED AND UNKNOWN IF ANOTHER IOL WAS IMPLANTED. PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. PATIENT STATUS POST PROCEDURE WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370695 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAPSULE TEAR OCCURRED. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION/APPLICATION OF THE PRELOADED INTRAOCULAR LENS (IOL). THE LENS WAS FULLY INSERTED AND REMOVED IN THE SAME PROCEDURE. THERE WAS NO LENS PLACED AND THE PATIENT WAS LEFT APHAKIC. THE CAUSE FOR THE CAPSULAR TEAR IS UNKNOWN AND IS SUSPECTED TO BE RELATED TO AN ANATOMY ISSUE. THE PATIENT HAD FULLY RECOVERED. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 21370689 ↗
• MalfunctionFeb 12, 2025Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS(IOL) WAS CHANGED TO IMPLANTED/REMOVED AS AN ATTEMPT WAS MADE. THE LENS WAS REMOVED DUE TO A SURGICAL COMPLICATION. INSERTION WAS ATTEMPTED, BUT THE IOL BECAME STUCK AND WAS SUBSEQUENTLY DAMAGED. THE LENS WAS DISCARDED IN OR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370683 ↗
• InjuryDec 13, 2024Adverse 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) EXPERIENCED A VERY SURPRISING HYPEROPIC RESULT, +1.75 -0.25 X 105 DURING A POST-OPERATIVE (OP) EXAM. THE LENS WAS EXPLANTED DURING SECONDARY PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20928958 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD CRIMPED PROXIMAL TO THE HAPTIC. THE LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE AND REPLACED WITH THE DIB00 LENS WITH 18.5 DIOPTER IN THE SAME PROCEDURE WITH OUT DIFFICULTY. PATIENT IS DOING FINE. BALANCED SALT SOLUTION (BSS) WAS USED AS THE CARTRIDGE LUBRICANT AND WAS USED AT ROOM TEMPERATURE. THERE WAS NO DELAY IN THE SURGERY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791631 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL IOL HAD A BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT AS IT WAS NOTICED PRIOR TO INSERTION. IT WAS REPLACED WITH ANOTHER IDENTICAL MODEL OF THE J&J IOL. THE PATIENT'S VISUAL ACUITY IS 20/25 AND THERE WERE NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642190 ↗
• MalfunctionOct 18, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) INADVERTENTLY EJECTED TOO EARLY. THE IOL TOUCHED THE EYE BUT WAS NOT IMPLANTED. THE CUSTOMER SPECIFIED THIS IS A ¿USER ERROR¿. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IOL OF THE SAME MODEL. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478232 ↗
• MalfunctionSep 27, 2024Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE FOR THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS BENT AT THE WRONG ANGLE. REPORTEDLY, SOMETHING WITH THE TIP WAS BENT OR WRONG. THE ISSUE WAS OBSERVED WHEN INSERTING THE DEVICE INTO THE PATIENT¿S RIGHT EYE. THE CARTRIDGE TIP HAD PATIENT CONTACT BUT THE LENS WAS STUCK INSIDE THE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER JNJ IOL MODEL DIB00 18.5 DIOPTER. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326738 ↗
• MalfunctionSep 4, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE IOL WAS FULLY INSERTED INTO THE EYE. THERE WERE TWO V SHAPED SCRATCHES IN THE CENTRAL OPTIC NOTED AFTER IMPLANTATION. A SECOND INSTRUMENT WAS USED TO REPOSITION THE IOL IN THE ANTERIOR CHAMBER, CUT AND REMOVE IT FROM THE EYE. A NEW IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT OR HIS EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20132651 ↗
• MalfunctionJul 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTER THAT WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS DELIVERED NORMALLY, BUT AFTER DELIVERY IT WAS NOTICED THAT THE TRAILING HAPTIC WAS MISSING (DETACHED). THE ISSUE WAS NOTICED DURING IMPLANTATION/APPLICATION. THERE WAS NO VITRECTOMY REQUIRED AND NO INCISION ENLARGED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684681 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THE IOL WAS REMOVED AND REPLACED (IN AND OUT) WITH ANOTHER DIB00 18.5 DIOPTER IOL. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448138 ↗
• MalfunctionMay 20, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS PLUNGER CAME OUT OF THE SIDE OF THE NOSE OF THE CARTRIDGE. IT WAS NOTICED DURING HANDLING PRIOR TO PATIENT CONTACT. SO THE LENS WAS NOT USED. BACKUP LENS IMPLANTED, AND AFTER IMPLANTATION, IT WAS NOTICED THAT THERE WAS A FIBER ON IT. THE SURGEON REMOVED THE FIBER BUT LEFT THE LENS IN PLACE. IT WAS NOTICED AFTER INSERTION INTO THE EYE. NO INFORMATION ABOUT INJURIES OR SURGICAL AND MEDICAL INTERVENTIONS WAS REQUIRED. THE PATIENT'S POST-OP STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356187 ↗
• MalfunctionApr 17, 2024Break; Failure to Fold; Failure to Advance; Break; Failure to Fold; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) MANGLED UPON ADVANCING THE LENS. THERE WAS NO PATIENT CONTACT. THE ISSUE OCCURRED AFTER THE SURGERY, THAT IT APPEARED TO HAVE TURNED SIDEWAYS ON THE ADVANCE AND JAMMED IN THE TIP OF THE CARTRIDGE. IN THE SURGEON'S OPINION THE PRODUCT FAILURE CAUSED THIS EVENT DIRECTLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DIB00 LENS OF THE SAME DIOPTER VALUE. FROM THE ADDITIONAL INFORMATION IT WAS LEARNED THAT THERE WAS NO USE ERROR. IT WAS BELIEVED THAT IT LOOKED LIKE THE LEADING HAPTIC STUCK TO CARTRIDGE AND TWISTED LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124543 ↗
• MalfunctionApr 9, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD POSTERIOR CAPSULE OPACIFICATION LIKE FILM/RESIDUE ON THE ACTUAL LENS. SURGEON WAS AT 2/3RD OF THE CASE AND LENS WAS LOADED CORRECTLY. CUSTOMER CLAIMS IT APPEARS LIKE CARTRIDGE COATING IS GETTING ON THE OPTIC. THEY WERE USING BALANCE SALT SOLUTION FOR HYDRATION. IT WAS INDICATED THAT ANOTHER CASE WAS HYDRATED WITH VISCOELASTIC INSTEAD OF BSS AND IT DID NOT HAVE THE RESIDUE. HOWEVER, ADDITIONAL INFORMATION SUGGEST THAT THE PCO-LIKE FILM WAS PRESENT BUT NOT VISIBLE AT ALL WHEN HYDRATED WITH VISCOELASTIC. THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT IMPACT POST-OP OR NEGATIVE EFFECTS. PATIENT INFORMATION CANNOT BE RELEASED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075212 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED. NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895957 ↗
• MalfunctionMar 7, 2024Break; Failure to Advance; Material Split, Cut or Torn; Break; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD INJECTED OUT AND THE PART OF THE HAPTIC/LENS WAS TORN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862162 ↗