TECNIS SIMPLICITY DIB00 (REF DIB00U0235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 05050474731837), received between Nov 8, 2021 and Jun 26, 2026 — classified as 8 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT THE HAPTICS WERE NOT INTACT AT THE TIME OF IMPLANTATION, AND THE SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK IN THE PRELOADED DELIVERY SYSTEM. AS A RESULT, ANOTHER IOL WAS IMPLANTED BY THE PHYSICIAN. THE EVENT OCCURRED DURING IMPLANTATION/APPLICATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640025 ↗
• MalfunctionApr 11, 2026Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED FROM THE MANUFACTURER. IT WAS STATED THAT IT WAS NOT SURE WHAT HAPPENED, BUT IT WAS OUT OF THE CARTRIDGE AND NOT FULLY IN THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848407 ↗
• MalfunctionMar 12, 2026Failure to Fold; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD AN UNFOLDING PROBLEM AND A MISSING HAPTIC. LENS WAS NOT USED AND WAS NOT IN CONTACT WITH PATIENT'S EYE, AND NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586978 ↗
• MalfunctionFeb 27, 2026Crack

  IT WAS REPORTED THAT AN IMPLANTED SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) CARTRIDGE TIP WAS CRACKED. THERE WERE NO PATIENT ISSUES. THE IOL WAS FULLY INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476912 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INSERTION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE LEADING HAPTIC EXERTED FORCE ON THE CAPSULAR BAG, RESULTING IN DAMAGE TO THE ZONULES ON THE OPPOSITE SIDE OF THE BAG. THIS CAUSED A TEAR IN THE CAPSULAR BAG AND THE PRESENCE OF VITREOUS, WHICH REQUIRED THE REMOVAL OF THE LENS AND THE PERFORMANCE OF AN ANTERIOR VITRECTOMY. THE PATIENT IS SCHEDULED FOR FOLLOW-UP WITH A RETINAL SURGEON. THE PRODUCT IS UNAVAILABLE FOR RETURN AND INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Zonular Dehiscence

  MAUDE report 23969466 ↗
• InjuryOct 20, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025 THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE, DESPITE ITS EXPIRATION DATE OF JULY 14, 2025. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO UNSPECIFIED RISKS HOWEVER, INFORMATION ABOUT THE REPLACEMENT LENS IS UNKNOWN. PATIENT PROGNOSIS POST-PROCEDURE IS ALSO UNKNOWN. PRODUCT EXPERIENCE CONFIRMED THE IOL WAS SHIPPED TO THE ACCOUNT (B)(6) 2024, PRIOR TO PRODUCT EXPIRATION. 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 23342807 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INJECTION OF THE DIB00 MODEL INTRAOCULAR LENS (IOL) A CAPSULAR BAG TEAR OCCURRED AND THE IOL WAS REMOVED FROM THE EYE. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE EVENT. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON IOL, MA60AC 22.5 THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO SERIOUS PATIENT INJURY HOWEVER, THE INCISION WAS ENLARGED, A 10-0 NYLON INTERRUPTED STITCH/SUTURE WAS USED AS A PROPHYLACTIC MEASURE TO CLOSE THE MAIN WOUND, AND AN UNPLANNED VITRECTOMY WAS PERFORMED. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 23096211 ↗
• MalfunctionSep 4, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO SCRATCHING. THE LENS WAS FULLY INSERTED DURING THE INITIAL PROCEDURE AND WAS LATER REMOVED DURING A SECONDARY SURGERY, REPLACED WITH A DIB00 LENS. THE PATIENT HAS FULLY RECOVERED & SATISFIED AND SEEING WELL. NO UNPLANNED COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968901 ↗
• MalfunctionAug 11, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED LENS HAD MISFIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778022 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTED IRRITATION TO BOTH EYES, WHEN SHE WAKES UP IN THE MORNING SHE IS EXPERIENCING A LOT OF MUCUS IN HER EYE. SHE BELIEVES IT WAS EITHER DUE TO HER SURGERY OR SHE IS POSSIBLY ALLERGIC TO THE IOL'S. PATIENT USED THREE (03) TYPES OF DROPS PRIOR TO HER SURGERY. ABOUT THREE (03) WEEKS AFTER THE SURGERY IS WHEN SHE NOTICED THE MUCUS OCCURRING, BUT IS NOT TOO SURE. PATIENT HAS CATARACT SURGERY FIRST, WENT BACK FOR A CHECK-UP, AND THEN WAS TOLD SHE WOULD NEED LASER SURGERY DONE ON THE LEFT EYE. LASER SURGERY WAS COMPLETED THEN ON APRIL 30TH THE RIGHT EYE SURGERY WAS COMPLETED. THE DROPS THAT SHE WAS USING ARE PREDNISOLONE, AND TWO OTHER ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Irritation; Hypersensitivity/Allergic reaction

  MAUDE report 22287627 ↗
• MalfunctionJun 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE, IT WAS NOTICED THAT THE HAPTIC WAS REPORTED TO BE BROKEN OFF, LEADING TO THE NEED FOR REMOVAL OF THE LENS. THE ISSUE WAS NOTICED AFTER IMPLANTATION/APPLICATION OF THE LENS. THE LENS WAS EXPLANTED IN DURING A SECONDARY SURGERY. THE VISUAL ISSUES WERE FIRST OBSERVED AFTER THE IMPLANTATION OF THE LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193888 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT¿S CAPSULAR BAG ¿BUSTED¿ AND THE PATIENT WAS LEFT APHAKIC. THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INVOLVED. THE EXTENT OF THE INVOLVEMENT WAS NOT PROVIDED. FOLLOW-UP WAS PERFORMED BUT THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER DETAILS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162655 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF PRELOADED INTRAOCULAR LENS (IOL) WITH A BENT/TWISTED OPTIC-HAPTIC FUNCTION, THE HAPTIC EXTRUDED FIRST FROM THE INJECTOR BUT WAS TWISTED UPSIDE DOWN COMPARED TO THE OPTIC ORIENTATION. THE LENS WAS REPLACED DURING THE SAME PROCEDURE, WHICH RESULTED IN A DELAY OF THREE MINUTES. THE PATIENT DID NOT EXPERIENCE ANY PERMANENT OR TEMPORARY IMPAIRMENT. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE ISSUE WAS IDENTIFIED DURING IMPLANTATION OF THE LENS. THE CAUSE OF BENT OPTIC/HAPTIC JUNCTION IS UNKNOWN. THE LENS WAS PARTIALLY INSERTED (~25% OUTSIDE THE INJECTOR) BEFORE THE INJECTOR AND IOL WERE REMOVED FROM THE EYE. IT WAS BELIEVE THE ISSUE OCCURRED DUE TO INCORRECT LOADING OF THE LENS INTO THE INJECTOR SET. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105087 ↗
• MalfunctionMar 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) HAD DEPLOYED STRAIGHT IN TO THE PATIENT LEFT EYE. THE SURGEON HAD MANIPULATED TO ACHIEVE THE DESIRED RESULT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520862 ↗
• MalfunctionFeb 25, 2025Break; Device Difficult to Setup or Prepare; Mechanical Jam; Break; Device Difficult to Setup or Prepare; Mechanical Jam

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) HAD A DEFECTIVE LOADER/INJECTOR, DAMAGED LENS, AND WAS IDENTIFIED DURING THE HANDLING OF THE LENS. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE LENS WAS STUCK IN THE INJECTOR AND WOULD NOT COME OUT. THE SURGEON DID NOT WANT TO USE FORCE AS THERE WAS RESISTANCE. SO, THE SURGEON ENDED UP OPENING ANOTHER LENS. THERE WAS A 2 MINUTE DELAY IN PROCEDURE. THE SURGEON DID NOT HAVE TO ENLARGE THE WOUND. THERE WERE NO COMPLICATIONS. THERE WERE NO ISSUES POST-OPERATIVE (OP). PATIENT HAD NO NEGATIVE CONSEQUENCES. NO OTHER DETAILS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464965 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS CRACKED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE OPTIC OF THE LENS WAS CRACKED. THE ISSUE WAS NOTICED AFTER IMPLANTATION OF THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH THE SAME MODEL AND SAME DIOPTER LENS IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233491 ↗
• MalfunctionJan 13, 2025Break; Ejection Problem; Break; Ejection Problem

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS DAMAGED AND FAILED TO DEPLOY. EXTENT OF PATIENT CONTACT WITH THE IOL IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146396 ↗
• MalfunctionJan 3, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT IS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS DAMAGED DURING ADVANCEMENT IN PREPARATION. THE SURGEON DID NOT OBSERVE ANY VISUAL ISSUES INITIALLY. HOWEVER, UPON ATTEMPTING TO INSERT THE LENS, IT BECAME EVIDENT THAT THE LENS WAS DAMAGED WITHIN THE CARTRIDGE CHAMBER. THE CARTRIDGE AND LENS WERE WITHDRAWN FROM THE EYE WITH NO PATIENT INJURY REPORTED. A NEW LENS WAS ACQUIRED AND INSERTED WITHOUT ANY ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072196 ↗
• InjuryDec 6, 2024Contamination; Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED AN EYHANCE INTRAOCULAR LENS (IOL) IN THE LEFT EYE. BUT PATIENT CAME IN WITH BLURRED VISION, CYSTOID MACULAR EDEMA AND A STRAND POST-OP. THE PATIENT WAS GIVEN PREDNISOLONE QID (4X/DAY), PROLENSA QID, MOXIFLOXIAN TID (3X/DAY). THE PATIENT WAS TEMPORARILY IMPAIRED. CLAIMED THAT DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. THE IOL REMAINS IMPLANTED. FOLLOW UP WITH THE DOCTOR NOTED THAT HE NOTICED THE SAME MATERIAL ON A PREPACKAGED 25G CYSTOME, LIKE THE ONE HE USED WHEN HE IMPLANTED THE SUSPECT IOL. IT WAS THE SAME LOOK AND SIZE AS THE ONE IN THIS PATIENT. HE HAS CONTACTED ALCON WHO IS THE MANUFACTURE OF THIS INSTRUMENT. THE DOCTOR STATED THAT HE FEELS THAT IT WAS ON THIS INSTRUMENT INSTEAD OF THE IMPLANT, THAT CAUSED THE STRAND. IT WAS ALSO STATED THAT THE DOCTOR TOOK PATIENT BACK INTO SURGERY AND HE GOT THEM FOREIGN BODY MATERIAL OUT. HE SENT IT OFF FOR REVIEW. IT WAS ALSO CONFIRMED THAT THE EYE DROPS ARE NORMAL PROTOCOL BUT THE CUSTOMER UPPED THE DOSAGES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Macular Edema; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871714 ↗
• MalfunctionNov 19, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE (B)(4) INTRAOCULAR LENS (IOL) HAD A FOREIGN MATTER. THE PATIENT HAD UNCOMPLICATED PHACO. PATIENT COMPLAINED OF BLURRED VISION AND A ¿BUTTERFLY¿ IN HER VISION. THERE WAS A 5-8 MM STRAND IN THE ANTERIOR CHAMBER ADHERENT TO THE IRIS AT 9 O¿CLOCK AND CYSTOID MACULAR EDEMA ON OCT (OPTICAL COHERENCE TOMOGRAPHY). THE IOL AND THE STRAND WERE REMOVED FROM THE PATIENT¿S EYE IN A POST OPERATIVE SURGERY. THE CUSTOMER SENT THE STRAND TO THEIR PATHOLOGY CENTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Macular Edema

  MAUDE report 20720859 ↗
• MalfunctionAug 13, 2024Crack; Crack

  IT WAS REPORTED THAT THERE WAS A SLIGHT DEFECT IN THE INSERTER OF THE PRELOADED INTRAOCULAR LENS (IOL) THAT WOULD NOT ALLOW THE TIP OF THE INSERTER TO ENTER THE PATIENT'S EYE TO INJECT THE IOL. ACCOUNT INDICATED THAT THE ISSUE WAS NOTICED DURING IMPLANTATION/APPLICATION. THE IOL WAS UNABLE TO BE INSERTED DUE TO THE DEFECT ON THE CARTRIDGE TIP. THE SLIGHT DEFECT IN THE INSERTER WAS A SMALL PLASTIC BURR ON THE END OF THE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH A NON JOHNSON AND JOHNSON LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977903 ↗
• MalfunctionApr 25, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) PRELOADED INTRAOCULAR LENS (IOL) FAILED. IT WAS NOTED TO HAVE SCRATCHES ON THE LENS FOLLOWING PLACEMENT. THE SURGEON REMOVED THE SCRATCHED LENS AND IMPLANTED ANOTHER LENS. THE ORIGINAL INTENDED PROCEDURE WAS PHACOEMULSIFICATION CATARACT WITH IOL IMPLANTATION WITHOUT ASTIGMATIC KERATOMY IN THEIR LEFT EYE. THROUGH FOLLOW-UP THE CUSTOMER STATED THAT TO THEIR KNOWLEDGE THERE WAS NO CAPSULE TEAR, VITRECTOMY OR INCISION ENLARGEMENT. NO FURTHER INFORMATION WAS PROVIDED. NOTE. MEDSUN PROGRAM. UF/IMPORTER REPORT#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19178050 ↗
• MalfunctionApr 9, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) PRELOADED INTRAOCULAR LENS (IOL) CAME OUT TOO SOON FROM THE PRELOADED DEVICE. THERE WAS PATIENT CONTACT. CUSTOMER WAS NOT ABLE TO PROVIDE MORE DETAILS AND EXPLAINED THAT THEY ARE WORKING WITH THEIR STAFF ON BETTER COMMUNICATION OF THESE ISSUES SO THAT THEY CAN PROVIDE A MORE THOROUGH REPORT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076376 ↗
• MalfunctionDec 11, 2023Contamination; Contamination

  IT WAS REPORTED THAT BLACK LINT WAS FOUND WITH A MONOFOCAL INTRAOCULAR LENS (IOL) DURING INSERTION IN THE OPERATIVE EYE OF THE PATIENT. THE SAMPLE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307901 ↗
• MalfunctionNov 20, 2023Break; Break

  THE SURGERY CENTER REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) DEVICE WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173810 ↗