TECNIS SIMPLICITY DIB00 (REF DIB00U0140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474731639), received between May 31, 2022 and Jan 13, 2026 — classified as 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE RIGHT EYE OF A PATIENT. DURING THE POST-OPERATIVE EXAMINATION, AN ISSUE WAS IDENTIFIED, NECESSITATING A SECONDARY SURGERY FOR LENS EXPLANTATION. THE REASON FOR EXPLANT WAS NOT SPECIFIED. A REPLACEMENT LENS OF THE SAME MODEL BUT LOWER DIOPTER (13.50D) WAS USED. THERE WAS NO SURGICAL DELAY IN PROCEDURE AND NO COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REPORTED. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE PATIENT DAILY ACTIVITIES WERE NOT AFFECTED. THE PATIENT HAS FULLY RECOVERED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Eye Injury; Visual Impairment

  MAUDE report 24064062 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SMALL TEAR AT THE HAPTIC OPTIC JUNCTURE. THE PRODUCT IS NOT AVAILABLE TO RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063468 ↗
• MalfunctionNov 18, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DAMAGED. THE PLUNGER WENT ON TOP OF THE IOL IN THE PRELOADED INJECTOR AND SPLIT THE LENS. THE CUSTOMER SAID THE PRODUCT WAS DAMAGED FROM THE MANUFACTURER. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578476 ↗
• MalfunctionNov 4, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) GOT STUCK IN THE WOUND OF THE EYE, WAS REMOVED, AND A NEW LENS WAS INSERTED WITHOUT INCIDENCE. THERE WAS PATIENT CONTACT BUT NO SERIOUS INJURY. THROUGH FOLLOW UP IT WAS LEARNED THAT THE LENS WAS FULLY DELIVERED AND THEN REMOVED AND REPLACED IN THE SAME PROCEDURE. NO ADDITIONAL SURGICAL MANEUVERS OUTSIDE YOUR NORMAL STANDARD OF PRACTICE WERE REQUIRED TO DELIVER AND/OR POSITION THE LENS. NO UNPLANNED SURGICAL INTERVENTIONS WERE REQUIRED. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. THERE ARE NO PLANNED SURGICAL INTERVENTIONS. THE PATIENT HAS FULLY RECOVERED. IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE RECOMMENDATIONS WERE FOLLOWED REGARDING THE PREPARATION AND USE OR THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469060 ↗
• MalfunctionOct 15, 2025Break; Misassembled; Mechanical Jam; Break; Misassembled; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS INCORRECTLY POSITIONED IN THE CHAMBER AND APPEARED TWISTED. THE ISSUE WAS OBSERVED DURING HANDLING BEFORE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT LENS WAS STUCK IN CARTRIDGE. THE HEALON DUO VISC AND BSS (BALANCED SALT SOLUTION) FROM JOHNSON & JOHNSON WERE USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286552 ↗
• MalfunctionAug 29, 2025Ejection Problem; Ejection Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS COMPLETELY IN THE PATIENT'S EYE HOWEVER, THE DEVICE DID NOT WORK AS INTENDED. THE INJECTOR WAS STUCK TO THE LENS AND WOULD NOT LET GO OF THE IOL. THE SURGEON HAS TO USE A SECOND INSTRUMENT TO DETACH THE INJECTOR FROM THE IOL. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED USING ANOTHER IOL. PATIENT PROGNOSIS POST-PROCEDURE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929507 ↗
• MalfunctionJan 30, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS GETTING STUCK IN THE WOUND DURING IMPLANTATION. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE, REMOVED AND REPLACED WITH THE ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21278957 ↗
• MalfunctionOct 30, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON INSERTED A PRELOADED MONOFOCAL LENS AND NOTICED A SCRATCH ON IT. THE LENS WAS SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE, WHICH DID NOT REQUIRE AN ENLARGED INCISION, SUTURES, OR VITRECTOMY. THERE WAS A 15-MINUTE DELAY IN THE PROCEDURE. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568393 ↗
• MalfunctionOct 23, 2024Crack; Crack

  IT WAS REPORTED THAT THE INJECTOR ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A WARPED TIP AND WAS UNUSABLE. THE ISSUE WAS NOTICED DURING HANDLING OF THE DEVICE PRIOR TO INSERTION. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519081 ↗
• InjurySep 25, 2024Break; Break

  IT WAS REPORTED THAT ON IMPLANTING THE PRELOADED INTRAOCULAR LENS(IOL) INTO THE PATIENT'S LEFT EYE, THE SURGEON HAD NOTICED A CRACK IN THE CENTER OF THE LENS. SO THE DEFECTIVE LENS WAS EXPLANTED WITH THE INTRAOCULAR SCISSORS. VITRECTOMY WAS REQUIRED. SURGERY WAS COMPLETED WITH NO COMPLICATIONS. THERE WAS INCISION ENLARGED AND SUTURES REQUIRED. THERE WAS DELAY IN THE PROCEDURE. THE PATIENT WAS OKAY. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT IT WAS UNKNOWN IF THE CRACK IN THE LENS WAS DUE TO USE ERROR, AS THE SURGEON WAS INEXPERIENCED WITH USING DIB00 INSERTER BUT ALSO CLAIMED THAT THE LENS WAS DEFECTIVE, WHICH COULD ALSO BE TRUE. THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER LENS IN THE SAME PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 20304091 ↗
• MalfunctionSep 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT IS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND SUBSEQUENTLY REMOVED. THE SURGEON INTENDED TO UTILIZE A THREE-PIECE IOL, BUT IT IS UNCERTAIN WHICH LENS WAS ULTIMATELY USED FOR COMPLETION. NO INJURY OR INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20282971 ↗
• MalfunctionSep 5, 2024Break; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Break; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS DAMAGED IN TRANSIT AND THERE WAS NO PATIENT CONTACT. THE INNER LENS BOX WAS DAMAGED AND THE SEAL WAS BROKEN. THE OUTER BROWN BOX WAS NOT DAMAGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20142315 ↗
• MalfunctionJun 18, 2024Scratched Material; Scratched Material

  THE SURGERY CENTER REPORTED SCRATCH ON A MONOFOCAL INTRAOCULAR LENS (IOL). THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564107 ↗
• MalfunctionJun 4, 2024Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF THE PRELOADED INTRAOCULAR LENS WAS BENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464282 ↗
• MalfunctionMay 10, 2024Device Difficult to Setup or Prepare; Ejection Problem; Device Difficult to Setup or Prepare; Ejection Problem

  IT WAS REPORTED DURING INSERTION THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS ADVANCING NORMALLY (WITH NORMAL TACO CONFIGURATION) UNTIL IT WAS HALFWAY THROUGH THE CLEAR CORNEAL INCISION. DESPITE PRESSURE AND ADJUSTMENT, THE LENS STOPPED ADVANCING THROUGH THE INCISION, THE CARTRIDGE STARTED RETRACTING OUT OF THE EYE, AND THE CARTRIDGE AND LENS COULD NOT BE INSERTED BACK INTO THE EYE WITH THE INJECTOR. THERE WAS SOME RESISTANCE WHEN TRYING TO ADVANCE THE IOL AND AN ANGLED MCPHERSON FORCEP WAS USED TO REMOVE THE IOL FROM THE INCISION. THE IOL WAS SEPARATED FROM THE INJECTOR AND THE DOCTOR COULD NOT INSERT THE IOL WITH FORCEPS OR IOL MANIPULATOR. THE SAME PROCEDURE COMPLETED SUCCESSFULLY USING ANOTHER DIB00 14.0 DIOPTER IOL THAT WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO INCISION ENLARGEMENT, MEDICAL INTERVENTION, SERIOUS PATIENT INJURY, SURGICAL INTERVENTION, SUTURES, OR VITRECTOMY. RESIDENT SURGEON DIFFICULTY MAY HAVE CONTRIBUTED TO THE EVENT MORE SO THAN A MANUFACTURING ISSUE BUT THE ACCOUNT WANTED TO MAKE SURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293571 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT DURING HANDLING/PRIOR TO INSERTION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. THE LENS WAS DISCARDED AND A BACK UP IOL WAS USED. THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS NO PATIENT ISSUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833920 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). A VITRECTOMY WAS PERFORMED DUE TO A MACULAR PUCKER. PATIENT REPORTED VISION IS GOOD 20/25 AND THERE IS NO GLARE IN OS IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Scar

  MAUDE report 18576118 ↗
• MalfunctionNov 23, 2023Break; Break

  IT WAS REPORTED UPON OPENING PRODUCT PACKAGING, THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS MANGLED IN THE LOADER, THERE WAS NO PATIENT CONTACT. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18202836 ↗
• MalfunctionApr 25, 2023Mechanical Problem; Scratched Material; Mechanical Problem; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) PLUNGER ADVANCED OVER THE LENS. IT WAS NOTED THAT THE LENS WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. THE ISSUE WAS OBSERVED DURING HANDLING, PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL, ZCB00, SAME DIOPTER OF +14.0) FOR THE LEFT EYE. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WAS ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812490 ↗
• MalfunctionSep 6, 2022Material Fragmentation; Inaccurate Delivery; Material Fragmentation; Inaccurate Delivery

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE INTRA-OCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE. THE HAPTIC WAS CUT UPON INSERTION INTO THE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366655 ↗
• MalfunctionSep 1, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THE DEVICE HAD A MELTED TIP. THERE WAS NO PATIENT CONTACT AND THE EVENT WAS OBSERVED UPON PRIMING THE LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341721 ↗
• InjuryAug 26, 2022Break; Break

  IT WAS INITIALLY REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CRACKED. THE LENS HAD TO BE EXPLANTED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS FULLY INSERTED INTO THE LEFT EYE AND THEN REMOVED AND REPLACED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZA9003, SAME DIOPTER). THE PATIENT HAD A CAPSULE TEAR AND A VITRECTOMY WAS PERFORMED. THE PATIENT OUTCOME WAS REPORTED TO BE UNKNOWN, AWAITING PARS PLANA VITRECTOMY (PPV), ENDOLASER (EL), AND GAS BUBBLE SURGERY RESULTS; HOWEVER, THE ACCOUNT ONLY CONFIRMED HAVING DONE A VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 15307564 ↗
• InjuryAug 26, 2022Break; Break

  IT WAS INITIALLY REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CRACKED. THE LENS HAD TO BE EXPLANTED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS FULLY INSERTED INTO THE LEFT EYE AND THEN REMOVED AND REPLACED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, DIB00, SAME DIOPTER). THE PATIENT HAD A CAPSULE TEAR AND A VITRECTOMY WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 15307481 ↗
• InjuryJul 20, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A DEFECT IN THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062168 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S RIGHT EYE WHEN THE SURGEON NOTICED THE LENS WAS BROKEN. THE SURGEON CUT THE LENS OUT AND DISCARDED THE LENS. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988868 ↗