TECNIS SIMPLICITY DIB00 (REF DIB00U0225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 05050474731813), received between Nov 19, 2021 and Jun 25, 2026 — classified as 28 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 79 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25628280 ↗
• MalfunctionJun 9, 2026Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION, THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS NOTED TO HAVE SCHMUTZ ON THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451860 ↗
• MalfunctionApr 28, 2026Scratched Material

  THE FOLLOWING WAS INITIALLY REPORTED REGARDING THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL). AFTER THE IOL WAS INJECTED INTO THE LEFT EYE AND THE HAPTICS UNFOLDED, THE CUSTOMER SAW A SCRATCH/DEFECT ON THE LENS. IRRIGATION AND ASPIRATION (IA) WAS USED TO CHECK IF IT WAS DEBRIS. THE CUSTOMER STATED IT WAS DEFINITELY A DEFECT. HOWEVER, THROUGH FOLLOW-UP THE CUSTOMER EXPLAINED THAT THE PRELOADED LENS WAS STUCK INSIDE THE INJECTOR AND WAS NOT ABLE TO BE IMPLANTED. THE IOL WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT LENS OF THE SAME MODEL. THE CUSTOMER CONTINUED TO EXPLAIN THAT SINCE THIS WAS A LENS EXCHANGE CASE SUTURES WERE USED AS IT IS STANDARD PRACTICE AFTER IOL REMOVAL. THE USE OF SUTURES WAS NOT RELATED TO THE DAMAGED LENS. THERE WAS NO VITRECTOMY REQUIRED. REPORTEDLY, THEIR OPERATIVE NOTES DO NOT SUGGEST ANY FUTURE ISSUES. THERE WERE NO FURTHER ISSUES. JOHNSON AND JOHNSON IS PERFORMING FOLLOW-UP TO GET CLARIFICATION ON THE REPORTED EVENT. WHEN INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024219 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING IMPLANTATION OF A PRELOADED INTRAOCULAR LENS (IOL), MODEL DIB00, THE LENS DID NOT FOLD AS EXPECTED. ADDITIONAL INFORMATION INDICATED THAT THE HAPTIC OR OPTIC WAS DAMAGED; HOWEVER, THE LENS REMAINED USABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME LENS. NO PATIENT INJURY WAS REPORTED, AND THERE WERE NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059742 ↗
• MalfunctionJan 12, 2026Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. AFTER INJECTION, THE IOL EXHIBITED ¿SCUFFS¿. THE SCUFFS WERE NOT VISUALLY SIGNIFICANT FOR THE PATIENT AND THE IOL REMAINED IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049687 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. POSTOPERATIVELY, THE PATIENT WAS MORE MYOPIC THAN ANTICIPATED. A SECONDARY PROCEDURE WAS PERFORMED TO EXPLANT THE ORIGINAL LENS AND REPLACE IT WITH THE SAME MODEL OF LOWER DIOPTER (20.0D). THE SURGERY DID NOT REQUIRE INCISION ENLARGEMENT, AN UNPLANNED VITRECTOMY, SUTURES, OR ANY DELAY. THE PATIENT REQUIRED NO ADDITIONAL MEDICAL ATTENTION OR MEDICATIONS BEYOND STANDARD CARE. THE PATIENT OUT COME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Visual Impairment

  MAUDE report 24029602 ↗
• InjuryDec 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN EXPLANT OCCURRED WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23903977 ↗
• MalfunctionDec 12, 2025Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE CUSTOMER THAT UPON OPENING THE PACKAGE, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00 WAS RECEIVED WITH THE OUTER BOX INTACT BUT THE IOL BOX DAMAGED. IT APPEARS THE WAREHOUSE MAY HAVE PLACED A DAMAGED IOL INSIDE THE ORDER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792012 ↗
• InjuryOct 30, 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 DEXTER (RIGHT EYE). POST-OPERATIVELY, PATIENT REPORTS COMPLAINTS OF THE APPEARANCE OF BAGS UNDER HER EYES AND BLURRY VISION IN HER OD, WHICH WAS NOT AS CLEAR AS THE OCULAR SINISTER (LEFT EYE). SHE INDICATED THAT THE BLURRY VISION STARTED AFTER SHE STOPPED USING THE PRESCRIBED EYE DROPS, WHICH SHE HAD USED FOR APPROXIMATELY THREE (03) WEEKS FOLLOWING THE INITIAL SURGERY. THE PATIENT COULD NOT READ THE NAME OF THE DROPS, SHE DESCRIBED THE BOTTLE AS WHITE WITH A NAVY BLUE CAP. THE PATIENT WAS ADVISED TO FOLLOW UP WITH HER DOCTOR ABOUT HER ISSUES. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. .

  Patient problems: Blurred Vision

  MAUDE report 23421228 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418394 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN LEFT EYE, THE PATIENT WAS UNHAPPY WITH THE VISION. THE ISSUE WAS REPORTED DURING THE POST-OPERATIVE EXAMINATION. SYMPTOMS PERSISTED FOR FOUR MONTHS. THE LENS WAS SUBSEQUENTLY EXPLANTED. REPLACEMENT LENS IS UNKNOWN. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 23100068 ↗
• MalfunctionSep 3, 2025Contamination; Contamination

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE IMPLANTATION OF A PRELOADED MONOFOCAL TECNIS EYHANCE INTRAOCULAR LENS IN THE PATIENT'S RIGHT EYE, THE SURGEON IDENTIFIED DEBRIS OR A PARTICLE ON THE LENS. THE OBJECT WAS REMOVED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957432 ↗
• MalfunctionSep 2, 2025Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING THE INSERTION OF A TECNIS EYHANCE SIMPLIFY INTRAOCULAR LENS (IOL) WITH A DIOPTER OF +22.5D, THE SURGEON OBSERVED A PIECE OF THREAD. THE THREAD WAS SUCCESSFULLY REMOVED DURING THE PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948706 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE INVOLVING THE DIB00 INTRAOCULAR LENS (IOL), A DEFECT ON PATIENTS CAPSULE WAS NOTED. A DIFFERENT LENS WAS USED TO COMPLETE THE SAME PROCEDURE AND THERE WAS NO PATIENT HARM. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 22857449 ↗
• InjuryJul 17, 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 DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT REPORTED COMPLAINTS OF DYSPHOTOPSIA AND REFRACTIVE SURPRISE WHICH PERSISTED FOR EIGHT (08) MONTHS. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, LI61AO +21.5. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22538423 ↗
• InjuryJun 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS INSERTED INTO A PATIENT'S EYE, BUT IT WAS DISCOVERED THAT ONE HAPTIC WAS MISSING FROM THE LENS. AS A RESULT, THE LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE, AND A NEW LENS WAS SUBSEQUENTLY INSERTED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE INCISION WAS ENLARGED MORE THAN USUAL TO REMOVE THE LENS FROM THE PATIENT'S EYE AND TWO SUTURES WERE REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS THE PATIENT IS STILL UNDER FOLLOW UP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367907 ↗
• MalfunctionJun 13, 2025Contamination; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT STRAY BLUE FIBERS WERE FOUND ON THE PRELOADED INTRAOCULAR LENS (IOL) IMPLANTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207187 ↗
• MalfunctionMay 2, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT EYE, BUT IMMEDIATELY REMOVED THE LENS DUE TO A DEFECT IN THE OPTIC. THE LENS WAS REMOVED IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953391 ↗
• InjuryApr 22, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DUE TO A CAPSULAR BAG RUPTURE UPON INSERTION, THE SURGEON REQUESTED DIFFERENT TYPES OF INTRAOCULAR LENSES (IOLS). A 25-GAUGE ANTERIOR VITRECTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH A LENS FROM ANOTHER COMPANY. NO ADDITIONAL COMPLICATIONS OCCURRED. FURTHER INFORMATION INDICATED THAT THE LENS WAS FULLY INSERTED. THE DOCTOR BELIEVES THAT THE INSERTER AND THE IOL WERE CAUGHT TOGETHER, PREVENTING THE IOL FROM RELEASING FROM THE INSERTER AND RESULTING IN A NASAL POSTERIOR TEAR. THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 21886066 ↗
• InjuryApr 17, 2025Wrong Label; Wrong Label

  A FEMALE PATIENT REPORTED EXPERIENCING NOTICEABLE CHANGES IN HER LEFT EYE (OS) OCULUS SINISTER FOLLOWING AN IMPLANTATION OF THE MONOFOCAL INTRAOCULAR LENS (IOL). A COUPLE OF WEEKS POST-SURGERY, THE PATIENT BEGAN TO PERCEIVE A SHIFT IN HER VISION WHEN EXPOSED TO SUNLIGHT, TRANSITIONING FROM NORMAL VISION TO BLURRY AND TUNNEL VISION. AS THIS SHIFT OCCURS, THE PATIENT EXPERIENCES A LOSS OF COLOR PERCEPTION, SEEING EVERYTHING IN SHADES OF GRAY, WHICH RESULTS IN DIZZINESS. SEEKING GUIDANCE, THE PATIENT CONTACTED HER SURGEON, WHO SUGGESTED THAT HER SYMPTOMS MIGHT BE DUE TO ADAPTATION ISSUES. WHILE THE PATIENT EXPRESSED SATISFACTION WITH BOTH OF HER LENSES, ESPECIALLY IN LOW-LIGHT CONDITIONS, THE PROBLEMS SHE FACES IN SUNLIGHT HAVE RAISED CONCERNS. THE PATIENT BELIEVES THE EYHANCE LENS IS MISREPRESENTED AS A MONOFOCAL LENS WHEN IT FUNCTIONS AS AN EXTENDED DEPTH OF FOCUS (EDOF) LENS, ALTERING ITS BEHAVIOR DEPENDING ON LIGHT CONDITIONS. ALTHOUGH PATIENT INITIALLY STRUGGLED WITH DISTANCE VISION, SHE NOTICED IMPROVEMENT AFTER SEVERAL WEEKS; HOWEVER, SHE CONTINUES TO EXPERIENCE VISION SHIFTS THAT COMPROMISE HER ABILITY TO SEE CLEARLY OUTDOORS. WHILE HER VISION IS 20/20 IN LOW LIGHT, SHE REPORT

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

  MAUDE report 21860665 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT HAD REFRACTIVE SURPRISE AND REPORTED BEING UNABLE TO DRIVE, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 19.5 DIOPTER IOL. THERE WAS NO PATIENT INJURY AND NO INCISION ENLARGEMENT DURING THE LENS EXCHANGE PROCEDURE. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/50 AND POST-OPERATIVE WAS 20/25. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21435116 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) CRACKED WHEN THE DOCTOR TRIED TO IMPLANT IT. IT WAS INDICATED THAT THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289079 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINT OF BEING VISUALLY DISABLED AND NEGATIVE DYSPHOTOPSIA. THE PATIENT HAD ATTEMPTED TO ADJUST AT SURGEON RECOMMENDATION FOR MORE THAN 6 MONTHS BUT WAS UNABLE TO. THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. IT WAS STATED THAT THE PRODUCT WAS HANDLED CORRECTLY ACCORDING TO THE DIRECTIONS FOR USE, AND THERE WERE NO COMPLICATIONS SUCH AS UNPLANNED INCISIONS OR VITRECTOMY DURING THE PROCEDURE. DYSPHOTOPSIA WAS RESOLVED IMMEDIATELY AFTER EXPLANTING THE LENS. PATIENT FEELS BETTER WITH REPLACED LENS. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21279911 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF DYSPHOTOPSIA AND REPLACED WITH A DCB00 22.5 DIOPTER IOL. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT PROGNOSIS POST-LENS EXCHANGE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21201722 ↗
• MalfunctionJan 3, 2025Scratched Material; Scratched Material

  CUSTOMER REPORTED A TECNIS EYHANCE INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN A PATIENT HAD TO BE REMOVED DUE TO MULTIPLE DEFECTS, SPECIFICALLY 3-4 SCRATCHES OR RESIDUE ON THE OPTIC SURFACE. THE SURGEON DECIDED TO CUT THE LENS IN HALF FOR REMOVAL. THE LENS HAS BEEN PLACED IN A SPECIMEN CUP FOR POTENTIAL FURTHER EXAMINATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072522 ↗