TECNIS SIMPLICITY DIB00 (REF DIB00U0230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 05050474731820), received between Jun 15, 2021 and Mar 9, 2026 — classified as 20 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE-PIECE, PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO SUBJECTIVE VISUAL DISTURBANCES. THESE SYMPTOMS PERSISTED FOR APPROXIMATELY THREE WEEKS AND FIVE DAYS AND WERE FIRST IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. A SECONDARY SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE ORIGINAL IOL, WHICH WAS THEN REPLACED WITH A SAME-MODEL IOL OF +21.5 DIOPTERS. THE SECONDARY PROCEDURE DID NOT REQUIRE ANY UNPLANNED SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED, AND NO SURGICAL DELAYS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 24551152 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REFRACTIVE SURPRISE WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE LENS WAS SUBSEQUENTLY EXPLANTED FROM THE PATIENT'S RIGHT EYE. THE REPLACEMENT LENS WAS A NON-JOHNSON & JOHNSON LENS OF +21.5 DIOPTER. THE PROCEDURE DID NOT REQUIRE AN UNPLANNED INCISION ENLARGEMENT, SUTURES OR VITRECTOMY. IT IS UNKNOWN IF THERE WAS ANY PROCEDURAL DELAY OR IF THE PATIENT SOUGHT ADDITIONAL MEDICAL ATTENTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24031813 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT WAS UNHAPPY WITH VISUAL OUTCOME AFTER IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00. DURING POST-OPERATIVE EXAM, THE PATIENT WAS NOT SEEING WELL. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A ZCB00 (22.5D). NO INCISION ENLARGEMENT, UNPLANNED SUTURE, VITRECTOMY, OR PROCEDURAL DELAY OCCURRED. PATIENT OUTCOME WAS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23885658 ↗
• MalfunctionDec 19, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A PROCEDURE, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS DAMAGED WHEN THE INJECTOR PLUNGER WENT ON THE TOP OF THE LENS. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED AT THE CUSTOMER SITE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847501 ↗
• MalfunctionSep 2, 2025Material Opacification; Material Opacification

  AN OPACITY IN THE OPTIC OF THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS NOTED AFTER IT'S IMPLANTATION IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, NO VITRECTOMY, AND THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DIB00 23.0 IOL. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS EXCELLENT. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED HOWEVER, PHOTOS OF THE LENS WERE PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948593 ↗
• MalfunctionAug 13, 2025Crack; Ejection Problem; Crack; Ejection Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED LENS COULD NOT BE ADVANCED DUE TO A CURVED OR DAMAGED CARTRIDGE TIP. THE LENS WAS SUBSEQUENTLY DISCARDED. THE ISSUE WAS IDENTIFIED DURING THE IMPLANTATION PROCESS, WITH ONLY THE CARTRIDGE TIP IN CONTACT WITH THE PATIENT'S LEFT EYE (OS). THE PATIENT FULLY RECOVERED, AND NO DAILY ACTIVITIES WERE AFFECTED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURE DELAY. THE CUSTOMER CONFIRMED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798188 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LENS WAS FOUND TO BE DEFORMED WHILE STILL IN THE DELIVERY SYSTEM, AND IT DID NOT COME INTO CONTACT WITH THE PATIENT'S EYE. ADDITIONAL INFORMATION REVEALED THAT THE LEADING HAPTIC WAS TURNED THE OPPOSITE WAY, WHILE THE TRAILING HAPTIC WAS STRAIGHT. THE TEAM WAS CONCERNED ABOUT INSERTING IT INTO THE EYE, SO THEY OPENED A NEW ONE. THERE WAS NO USE ERROR AND THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475613 ↗
• MalfunctionJun 27, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED BY THE INJECTOR DURING THE PROCEDURE. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP LENS OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS SUCH AS A CAPSULE TEARS, VITRECTOMIES, OR SUTURES. THE CUSTOMER SUGGESTED THAT THE ISSUE MIGHT HAVE BEEN RELATED TO USE ERROR, AS BALANCED SALT SOLUTION WAS USED DURING THE PROCEDURE. HOWEVER, IT WAS CLARIFIED THAT THE USE OF BALANCED SALT SOLUTION IS CONSISTENT WITH THE DIRECTIONS FOR USE AND DOES NOT CONSTITUTE A USE ERROR. THE CUSTOMER ALSO MENTIONED THAT, FOLLOWING CONSULTATION WITH A JOHNSON AND JOHNSON REPRESENTATIVE, THE ISSUE STOPPED OCCURRING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352073 ↗
• InjuryJun 20, 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). DUE TO PATIENT COMPLAINTS OF NEGATIVE DYSPHOTOPSIA WHICH IMPACTED HIS QUALITY OF LIFE, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, B&L LI61A0 LENS. THERE WAS NO PATIENT INJURY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS SYMPTOMS RESOLVED ENTIRELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22301203 ↗
• 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 DEXTER (RIGHT 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. AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Irritation; Hypersensitivity/Allergic reaction

  MAUDE report 22287755 ↗
• InjuryMay 9, 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 PATIENT'S RIGHT EYE AS THE PATIENT'S WAS BOTHERED BY MYOPIA MYOPIC RETRACTIVE ERROR WAS INTOLERANT OF SPECTACLES AND ANISOMETROPIA. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21998654 ↗
• InjuryMar 14, 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 PATIENT'S EYE. THE ISSUE WAS NOTICED AFTER IMPLANTATION/APPLICATION OF THE LENS. THE LENS WAS REMOVED IN THE SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO PATENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21612779 ↗
• InjuryMar 5, 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 EYE DUE TO ASTIGMATISM. THE SYMPTOMS OF ASTIGMATISM WERE NOTICED ONE WEEK POST-OP SURGERY. THE LENS WAS EXPLANTED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS SUTURES PERFORMED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE IMPLANTED LENS DID NOT CONTRIBUTE TO ASTIGMATISM. THERE WAS NO USE ERROR. THE REPLACED LENS HAD SATISFIED/CORRECTED THE PATIENT¿S ASTIGMATISM. THERE WERE NO ANY DEBILITATING CONDITIONS IN PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21527733 ↗
• MalfunctionFeb 25, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS HAD A BROKEN SEAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465207 ↗
• MalfunctionFeb 20, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED LENS INJECTOR FAILED TO FUNCTION PROPERLY. THE LENS WAS REMOVED USING FORCEPS. THIS ISSUE WAS NOTICED DURING THE IMPLANTATION AND APPLICATION PROCESS. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428184 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21230692 ↗
• MalfunctionDec 3, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) PRODUCT WAS DEFECTIVE DURING THE LOADING PROCESS. THE IOL DID NOT TOUCH THE PATIENT'S EYE. SURGEON USED THE BACK-UP IOL. IT WAS NOTED THAT THERE HAD BEEN AN ISSUES WITH IT/ WITH ADVANCING IT. THE CIRCULATOR DOCUMENTED THAT THE FIRST LENS WAS BROKEN/DOES NOT WORK. THERE WAS RESISTANCE WHEN ADVANCING IT. THE ORIGINAL LENS WAS WASTED FOR BEING DEFECTIVE. THE PATIENT RECOVERED AND WENT HOME WITHOUT ANY COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839109 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT THE LENS WAS WASTED, DAMAGED FROM MANUFACTURER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727919 ↗
• MalfunctionNov 14, 2024Break; Break

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN DEFECTIVE. EXTENT OF PATIENT CONTACT WITH THE IOL IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689223 ↗
• MalfunctionOct 29, 2024Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS RECEIVED WITH THE OUTER SHIPPING BOX AND THE INNER LENS BOX DAMAGED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562225 ↗
• MalfunctionOct 2, 2024Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn; Manufacturing, Packaging or Shipping Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS DEFECTIVE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT UPON TIME OUT AND ON OPENING OF LENS, STAFF HAD NOTICED BOX OF LENS WAS SMASHED UP ON ONE SIDE OF BOX. THE LENS WAS OPENED AND WAS PASSED OFF ON THE FIELD. THE DOCTOR HAD INSPECTED THE LENS AND IT WAS DETERMINED TO HAVE BEEN TORN. THE LENS WAS STILL IN ONE PIECE BUT THE LENS WAS TORN ALMOST IN HALF. SO THE LENS WAS NOT INSERTED AND WAS DISCARDED. BACK UP LENS OF THE SAME MODEL AD DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352157 ↗
• MalfunctionSep 25, 2024Break; Break

  IT IS REPORTED THAT DURING HANDLING, ONE ARM OF THE HAPTIC ON THE PRELOADED MONOFOCAL LENS WAS INADVERTENTLY BENT, BUT THE LENS DID NOT TOUCH THE PATIENT. THE SAME MODEL LENS WAS USED TO COMPLETE THE PROCEDURE. THE INCIDENT HAD NO EFFECT ON THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304185 ↗
• MalfunctionSep 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT IS REPORTED THAT THE IOL WAS SUCCESSFULLY IMPLANTED, AND DURING THE IMPLANTATION, THE LENS FLIPPED, BUT THE PROCEDURE WAS PERFORMED SUCCESSFULLY. THE LENS WAS ABLE TO BE UNFOLDED BACKWARDS IN THE EYE AND ADJUSTED WITHOUT ANY ISSUE. THE IOL WAS USED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163855 ↗
• InjuryAug 26, 2024Adverse 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. THE REASON FOR EXPLANT IS UNKNOWN. PATIENT STATUS IS UNKNOWN. THROUGH FOLLOW-UP WITH THE FACILITY, IT WAS LEARNED THAT THE SURGEON FULLY INSERTED THE LENS AND THE PATIENT HAD SOME SORT OF "REACTION TO IT", THEREFORE IT WAS REMOVED IN THE SAME PROCEDURE AND REPLACED WITH AN ANTERIOR CHAMBER LENS. THE PATIENT'S OPERATIVE REPORT FOR THE LEFT EYE CATARACT SURGERY WAS ALSO RECEIVED, WHICH REPORTED THAT THERE WERE NO COMPLICATIONS. THE DESCRIPTION OF THE PROCEDURE INCLUDED THE SURGEON'S STANDARD PRE-OPERATIVE AND INTRA-OPERATIVE SURGERY STEPS WHICH WERE FOLLOWED. ZONULAR DEHISENSE WAS NOTED. A CAPSULAR TENSION RING WAS PLACED. HALF OF THE NUCLEUS WAS REMOVED VIA PHACOEMULSIFICATION. FOR IMPROVED CAPSULAR SUPPORT AN IOL PLACEMENT WAS ATTEMPTED WITHOUT SUCCESS. THE IOL EXPLANTED WITHOUT DIFFICULTY. ANTERIOR VITRECTOMY WAS PERFORMED WITH A COMBINATION OF VITRECTOR AND SCISSORS AT THE WOUND. AN ANTERIOR CHAMBER (AC) IOL (NON J&J IOL, 18.5 DIOPTER) WAS PLACED AND THE WOUND WAS CLOSED WITH A 10-0 NYLON SUTURES. THE PATIENT WAS DISCHARGED WITH SAME DAY FOLLOW-UP WITH RETINAL SPECIALIST. THE INCISION SITES WERE HYDRATED WIT

  Patient problems: Zonular Dehiscence

  MAUDE report 20068393 ↗
• MalfunctionAug 21, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED ON THE OPTIC. THE IOL WAS REMOVED AND REPLACED DURING THE SAME SURGERY. A DELAY IN PROCEDURE WAS REPORTED. THERE WAS NO VITRECTOMY REQUIRED. IT WAS UNKNOWN IF AN INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY, NOR NO SURGICAL INTERVENTION OUTSIDE THE STANDARD OF CARE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009588 ↗