TECNIS SIMPLICITY DIB00 (REF DIB00U0210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05050474731776), received between Aug 11, 2021 and Jun 5, 2026 — classified as 22 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 19, 2026Open, Classified

   Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

   Z-1634-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Difficult to Insert

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, DID NOT SEAT PROPERLY IN THE PATIENT¿S EYE FOLLOWING IMPLANTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PATIENT DURING THE SAME SURGICAL PROCEDURE. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411290 ↗
• MalfunctionMay 5, 2026Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. SPIDER-LIKE WEBS WERE OBSERVED ON THE LENS SURFACE. DURING THE SAME PROCEDURE THE SURGEON REMOVED THE AFFECTED IOL AND SUCCESSFULLY COMPLETED THE SURGERY USING A REPLACEMENT LENS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076305 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S CAPSULE WAS DAMAGED AFTER THE DIB00 MODEL INTRAOCULAR LENS (IOL) TOUCHED THE EYE, THERE WAS NO DAMAGE TO THE IOL ITSELF. THE SAME PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON-JOHNSON & JOHNSON IOL, MA60AC, THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE FOLLOWING ARE ALL UNKNOWNS: INCISION ENLARGEMENT, SERIOUS PATIENT INJURY, SUTURES, VITRECTOMY, AND PATIENT PROGNOSIS POST-PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 24285116 ↗
• InjuryDec 10, 2025Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF A LENS POWER ERROR RESULTING IN BLURRY VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 19.0 IOL. THE FOLLOWING ARE ALL UNKNOWNS: INCISION ENLARGEMENT, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), IF MEDICAL ATTENTION WAS REQUIRED, SUTURES, VITRECTOMY, AND PATIENT STATUS POST LENS EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23774938 ↗
• InjuryDec 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  AFTER THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED THE CAPSULE WAS BROKEN/RIPPED. DURING THE PROCEDURE, THE HAPTICS WERE INITIALLY STUCK TOGETHER, AND WHILE ATTEMPTING TO PLACE THE HAPTIC IN THE CAPSULAR BAG, THE HAPTICS RELEASED, AND A TEAR IN THE CAPSULE WAS OBSERVED. THE LENS WAS SUBSEQUENTLY REMOVED. IT IS UNKNOWN IF ANOTHER IOL WAS IMPLANTED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 23764656 ↗
• InjuryDec 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE ON (B)(6) 2025. THE PATIENT RETURNED (B)(6) 2025 FOR A LENS REPOSITIONING, THE DOCTOR ATTEMPTED TO REPOSITION THE IMPLANTED DIB00 IOL AND WAS NOT SATISFIED WITH THE REPOSITION. THE IOL WAS EXPLANTED AND REPLACED WITH AN ANTERIOR CHAMBER (AC) IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 23723198 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS OPENED/UNUSED. A VITRECTOMY WAS REQUIRED AND A THREE PIECE LENS WAS USED INSTEAD. THROUGH FOLLOW UP, IT WAS LEARNED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT REQUIRING A BACKUP PRODUCT, AS IT INVOLVED A LENS CHANGE. THE CUSTOMER DID NOT PROVIDE INFORMATION IF THE PRODUCT HAD PATIENT CONTACT AND THE CUSTOMER INDICATED THE PATIENT'S SITUATION/INFORMATION WILL NOT BE DISCUSSED FURTHER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23587356 ↗
• MalfunctionNov 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN REMOVED. THE REASON FOR THE REMOVAL IS UNKNOWN. IT IS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498180 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PRELOADED, MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23376608 ↗
• MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE AND WAS FOUND TO HAVE ONLY ONE HAPTIC. THE LENS WAS REMOVED AND REPLACEMENT WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. THE DAMAGE WAS NOT ATTRIBUTED TO USER ERROR. THERE WERE NO REPORTS OF A CAPSULE TEAR, UNPLANNED VITRECTOMY, OR PATIENT INJURY. INFORMATION REGARDING INCISION ENLARGEMENT, SUTURES, DELAY IN PROCEDURE, MEDICATION OUTSIDE THE STANDARD OF CARE, AND PATIENT OUTCOME ARE UNKNOWN. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005259 ↗
• MalfunctionAug 21, 2025Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED BY A CUSTOMER THAT A PRELOADED TECNIS EYHANCE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED. REPORTEDLY THE HAPTIC WAS NOT FOLDED CORRECTLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867810 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED LENS WAS IMPLANTED BUT HAD TO BE REMOVED DUE TO ZONULAR INSTABILITY. THE SURGERY WAS COMPLETED IN THE SAME PROCEDURE WITH ANOTHER COMPANY'S LENS. ADDITIONAL INFORMATION REVELED THAT THE LENS WAS EXPLANTED DUE TO ZONULAR INSTABILITY AND A 3 PIECE INTRAOCULAR LENS WAS USED INSTEAD. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Zonular Dehiscence

  MAUDE report 22493936 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT A PRE-LOADED INTRAOCULAR LENS HAPTIC WAS BENT PRIOR TO INSERTION, HOWEVER THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379068 ↗
• MalfunctionJun 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A LENS HAD A LEADING HAPTIC THAT BROKE OFF PRIOR TO INSERTION AND THERE WAS NO PATIENT CONTACT WITH THE LENS. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN INTRAOCULAR LENS. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366458 ↗
• MalfunctionApr 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY SEVERED OFF. ALTHOUGH INITIALLY THE SURGEON DECIDED AGAINST REMOVING THE LENS IT WAS EVENTUALLY EXPLANTED IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912402 ↗
• InjuryFeb 12, 2025Break; Break

  AFTER THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) A VITRECTOMY WAS REQUIRED, IT WAS ALSO REPORTED THE IOL WAS DAMAGED. THE IOL WAS REMOVED AND THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO PROCEDURAL DELAYS, AND NO SUTURES 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. 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 21370461 ↗
• MalfunctionFeb 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT STICKING HAPTICS ENCOUNTERED DURING SURGICAL PROCEDURE WHICH THE SURGEON HAD TO USE TWO DIFFERENT INSTRUMENTS AND THEN GO IN WITH IRRIGATION/ASPIRATION (IA) AGAIN TO FREE THE HAPTICS. THROUGH FOLLOW UPS, IT WAS LEARNED THAT THE LENS REMAINS IMPLANTED AND NO ISSUES WITH THE PATIENT OUTCOME REPORTED. THE SURGERY JUST TOOK LONGER TO SEPARATE THE STICKING HAPTICS. NO OTHER SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. NO PATIENT INJURY REPORTED. BALANCED SALT SOLUTION (BSS) WAS USED FOR PREPARATION OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE STICKING HAPTICS ISSUE HAPPENED IN TWO CASES. THIS EMDR REPORT PERTAINS TO THE FIRST EVENT WITH THE LENS DIB00, SN (B)(6). THE SECOND EVENT DOES NOT MEET THE REPORTABILITY CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290890 ↗
• MalfunctionJan 30, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS STUCK IN THE WOUND DURING IMPLANTATION. THE LENS WAS INSERTED IN TO PATIENT'S RIGHT EYE, REMOVED AND REPLACED WITH 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 21279692 ↗
• MalfunctionJan 18, 2025Contamination; Mechanical Jam; Scratched Material; Contamination; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) GOT STUCK INSIDE THE CARTRIDGE. THE IOL WAS NOT CLEAR AS IT HAD A SCRATCH AND DEBRIS. THE IOL DID NOT CONTACT THE PATIENT AND WAS NOT INSERTED INTO THE PATIENT¿S LEFT EYE. HOWEVER, THE INCISION WAS ENLARGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT JNJ LENS OF THE SAME MODEL AND DIOPTER. THE PATIENT OUTCOME WAS REPORTED AS ¿NOT SURE¿. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186439 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT DUE TO BLURRY VISION, SHADOWS GHOST IMAGES, GLARES AND STARBURSTS. THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE PATIENT COULD NOT DRIVE AT NIGHT DUE TO VISUAL DISTURBANCES. THE BEST CORRECTED VISUAL ACUITY(BSCVA) PRE-OP WAS 20/50. THE BEST CORRECTED VISUAL ACUITY(BSCVA) POST-OP WAS 20/20. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Flashers; Visual Disturbances; Visual Impairment

  MAUDE report 21085968 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 21023718 ↗
• MalfunctionDec 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS EXPERIENCED ISSUES WITH STUCK HAPTICS DURING DELIVERY INTO THE EYE, TAKING APPROXIMATELY 15 MINUTES TO UNFOLD THE HAPTICS THAT WERE ADHERED TO THE OPTIC. HOWEVER, THE IOLS HAVE BEEN IMPLANTED WITHOUT ANY ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023664 ↗
• MalfunctionDec 4, 2024Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE; THE TIP OF THE INSERTER WAS BENT. THE SURGEON TRIED TO USE IT, BUT THE LENS FAILED TO SLIDE THROUGH. THERE WAS PATIENT CONTACT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE LENS ITSELF WAS NOT DAMAGED, JUST THE TIP OF THE CARTRIDGE/INSERTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER LENS IMPLANTED IN THE LEFT EYE. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME WAS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843528 ↗
• MalfunctionNov 22, 2024Contamination; Contamination

  IT WAS REPORTED THAT A TECNIS EYHANCE INTRAOCULAR LENS (IOL) HAD FIBERS IN BACK OF IOL WHERE THE IOL CREASES. THE DOCTOR WAS ABLE TO REMOVE THE FIBERS USING THE FORCEPS AND PROVISC AND THE IOL REMAINS IN THE PATIENT'S EYE. THE IOL STILL REMAINS IN THE PATIENT'S EYE. THE PATIENT¿S OUTCOME, STATUS IS FINE. THE SUSPECT PRODUCT AND FOREIGN MATERIAL WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759676 ↗
• MalfunctionOct 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CASES WITH THE MONOFOCAL INTRAOCULAR MONOFOCAL INTRAOCULAR LENSES (IOLS) HAD EXTREMELY STICKY HAPTICS. ON THE SECOND CASE, THE DOCTOR WAS UNABLE TO GET THE HAPTIC OFF THE OPTIC AND UNFORTUNATELY HAD TO CLOSE WITH THE HAPTIC STILL STUCK TO THE OPTIC. THROUGH FOLLOW UPS, IT WAS INDICATED THAT THERE WAS NO EXTRA MANEUVERS DONE TO POSITION OR REMOVE THE LENS. THAT THESE WERE STANDARD CATARACT SURGERIES. ON THE SECOND CASE, ONE HAPTIC REMAINED FIRMLY ATTACHED TO THE CENTER OF THE LENS AND DID NOT RELEASE DESPITE MULTIPLE ATTEMPTS. DURING THIS PROCESS, AN ANTERIOR CAPSULAR RENT WAS CREATED AND THE PATIENT IS SEEING A RETINA SPECIALIST TO DETERMINE IF THE LENS IS STABLE IN THE BAG. THE HAPTIC HAS RELEASED FROM THE CENTER OF THE OPTIC NOW AT POST OP WEEK-1. THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT CAPTURES THE ISSUES REPORTED WITH THE SECOND CASE. A SEPARATE REPORT WAS SUBMITTED FOR THE ISSUES REPORTED WITH THE FIRST CASE.

  Patient problems: Capsular Bag Tear

  MAUDE report 20549788 ↗