TECNIS SIMPLICITY DIB00 (REF DIB00U0135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474731622), received between Jul 30, 2021 and Aug 16, 2026 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Contamination

  It was reported that, during the initial stages of implanting a single-piece preloaded monofocal intraocular lens (IOL), a clear plastic particle was observed in the anterior chamber. The lens was not implanted, and the particle was retrieved. The reporter indicated that the particle was not believed to have originated from the IOL. No patient complications or adverse effects were reported. A backup lens was used to complete the procedure. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267130 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE, THE PATIENT WAS UNABLE TO ADAPT TO THE LENS AND NEAR TARGET. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL OF THE SAME MODEL WITH +10.5 DIOPTER. THE ISSUE WAS FIRST OBSERVED DURING A POST-OPERATIVE EXAMINATION AND PERSISTED FOR APPROXIMATELY TWO MONTHS AND THREE WEEKS. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. IT WAS UNKNOWN IF THERE WERE ANY SURGICAL DELAYS OR MEDICATION PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. DIRECTIONS FOR USE WAS FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 24032866 ↗
• MalfunctionMay 12, 2025Break; Break

  DURING THE LOADING PROCEDURE, A CRACK WAS NOTED IN THE PERIPHERAL OF THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL). NO ACTION WAS NEEDED, AND THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005481 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PHACOEMULSIFICATION SURGERY FOR THE RIGHT EYE, DURING WHICH A PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED. POST-INSERTION OF THE LENS, THERE WAS A NOTED VITREOUS LOSS, LEADING TO THE EXPLANTATION OF THE LENS AND PERFORMANCE OF A VITRECTOMY. SUBSEQUENTLY A NON JNJ LENS WAS IMPLANTED INCLUDING INCISION ENLARGEMENT AND SUTURES PERFORMED. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21329311 ↗
• MalfunctionNov 21, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL TECNIS SIMPLICITY INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE DUE TO THE CRACKED OPTICS OF THE LENS. SIGNIFICANT RESISTANCE WAS ENCOUNTERED UPON ROTATION/INJECTION. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY NEEDED. THE LENS WAS REPLACED WITH ANOTHER LENS, BUT WITH AN UNKNOWN DIOPTER. THE PATIENT'S POST-PROCEDURE STATUS IS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187459 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS WASTED. THE CUSTOMER NOTICED THE LENS WAS BROKEN BEFORE IT WAS USED IN THE PATIENT¿S RIGHT EYE. THE LENS WAS WASTED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. REPORTEDLY, THE PATIENT HAS PRE-EXISTING BLEPHAROPHIMOSI. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882702 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. THE PATIENT EXPERIENCED AN UNUSUAL INFLAMMATION CENTERED AROUND THE IOL. THEIR VISUAL ACUITY DECREASED, AND THEY EXPERIENCED PHOTOPSIAS AND PHOTOPHOBIA. THE EYE WAS CULTURED AND A TEAR ORGANISM WAS NOT SEEN. THE PATIENT WAS ADMINISTERED INTRAVITREAL INJECTION OF VANCOMYCIN, CEFTAZADIME, AND DEXAMETHASONE. IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Endophthalmitis; Eye Irritation; Eye Pain; Inflammation; Visual Disturbances

  MAUDE report 17733671 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S RIGHT EYE THEY EXPERIENCED FLOATERS AND RINGS WHICH WERE WORSENING. THE IMPLANT WAS A STANDARD PROCEDURE WITH NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, OR SUTURES. THE POST OPERATIVE STATUS AFTER THE IOL IMPLANT WAS UNEVENTFUL. HOWEVER, THE SYMPTOMS WERE NOTICED ONE DAY POST-OPERATIVE AND PROGRESSIVELY WORSE AFTER WEEK ONE. TO AID THE PATIENT IN SEEING THE COMPUTER MONITOR THEIR MYOPIC TARGET WAS -0.41. HOWEVER, POST OPERATIVE DATA ON WEEK TWO (POW2) SHOWED WORSENING FLOATERS AND RINGS. THE PATIENT HAS PRE-EXISTING SYNERESIS WITH KNOWN POSTERIOR VITREOUS DETACHMENT (PVD) IN THEIR RIGHT EYE. HIGH MYOPE WITH LONG AXIAL LENGTH(AL) 26.58. POST-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) IS 20/30 NO HOLES OR TEARS, SYNERESIS PVD IS STABLE. WHEN EXAMINED POST-OPERATIVELY, THE PATIENT DESCRIBED PERFECT CIRCLES DIFFUSELY WITHIN HIS VISION ALL DIFFERENT SIZES WITH A CENTRAL PINPOINT DOT IN THE MIDDLE. THE CIRCLES HAVE GOTTEN WORSE SINCE THEIR POST EXAM ON WEEK TWO. PATIENT MOSTLY NOTICES THE CIRCLES WHEN OUTDOORS AND PLAYING TENNIS. LESS PROMINENT IN THE CLINIC WITH DILATION DROPS IN PLACE. PATI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Flashers; Halo; Vitreous Floaters

  MAUDE report 16621449 ↗
• MalfunctionJan 30, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS FOLDED AND STICKING OUT OF THE FOLDER AND BENT. THERE WAS NO USE ERROR. THE EVENT WAS OBSERVED DURING HANDLING BUT PRIOR TO INSERTION INTO THE EYE. THERE WAS NO PATIENT CONTACT AND NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16267690 ↗
• MalfunctionSep 7, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER INSERTION INTO THE LEFT EYE (OS), IT WAS NOTICED BY THE SURGEON THAT THE HAPTIC WAS MISSING FROM THE INTRAOCULAR LENS (IOL). THE IOL WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 13.5 DIOPTER. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375470 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A PATIENT EXPERIENCED HALOS/GLARE IN THEIR LEFT EYE POST A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE. SURGEON WAS NOT CERTAIN IF THERE WAS A CORRELATION BETWEEN THE NEWLY IMPLANTED INTRAOCULAR LENS (IOL) AND THE YAG PROCEDURE PERFORMED AFTER IMPLANTATION. ACCOUNT INDICATED THAT IT WAS NOT CLEAR IF THE YAG WAS PERFORMED PROACTIVELY AS PART OF THEIR PROCESS OR IF IT WAS DONE TO TREAT THE SYMPTOMS OF HALOS/GLARE. AT THAT TIME THE IMPLANT DATE AND IOL SERIAL NUMBER WERE NOT PROVIDED. THE LENS REMAINED IMPLANTED WITH NO PLANS TO EXCHANGE THE IOL. FURTHER INFORMATION RECEIVED ON 5/6/2022 PROVIDED THAT DURING THEIR LAST POST-OPERATIVE VISIT ON (B)(6) 2022 THE PATIENT WAS COMPLAINING OF BLURRY VISION, DIFFICULTY DRIVING AT NIGHT, GLARE/HALO AROUND LIGHTS, AND ISSUES WITH DEPTH PERCEPTION ESPECIALLY WITH INTERMEDIATE VISION. THE PATIENT INDICATED BEING TEMPORARILY IMPAIRED AND THE VISUAL ISSUES SIGNIFICANTLY AFFECT HER DAILY ACTIVITIES. ACCOUNT PROVIDED THAT THE PATIENT HAD THE IOL EYHANCE IMPLANTED IN (B)(6) 2021, THEN YAG WAS PERFORMED ON (B)(6) 2021 AS POSTERIOR CAPSULE OPACIFICATION (PCO) WAS OBSERVED. THE POST-OPERATIVE VISION WAS PROVIDED AS -20/25. SURGEO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14569828 ↗
• InjuryMar 10, 2022Break; Break

  IT WAS REPORTED THAT UPON IMPLANTING THE INTRAOCULAR LENS (IOL), THE DOCTOR NOTICED A CRACK IN THE BODY OF THE LENS. THE IOL WAS REMOVED AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE INCISION WAS SLIGHTLY ENLARGED. THE IOL WAS DISCARDED AND WILL NOT BE RETURNED TO J&J. REPORTEDLY, THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727421 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHOULDER OF THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) TORE THE POSTERIOR CAPSULE OF THE PATIENT'S LEFT EYE AND THE LENS WAS CUT OUT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT NO ADDITIONAL MEDICAL/ SURGICAL INTERVENTIONS WERE REQUIRED OR ARE PLANNED. IT WAS ALSO CONFIRMED THAT THERE WAS NEITHER ANY DAMAGE TO THE HAPTIC OR LENS NOR ANY PRE-EXISTING PATIENT CONDITION THAT CONTRIBUTED TO THE EVENT. ANOTHER COMPETITOR LENS WAS PLACED AS THE REPLACEMENT AND THE PATIENT IS DOING FANTASTIC POST-OPERATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12256903 ↗