TECNIS SIMPLICITY DIB00 (REF DIB00U0175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05050474731707), received between Jul 27, 2021 and Sep 18, 2026 — classified as 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Visual Disturbances

  MAUDE report 50829688 ↗
• MalfunctionMay 8, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS WASTED BECAUSE THE SURGEON WAS UNABLE TO DEPLOY THE LENS INTO THE PATIENT¿S RIGHT EYE. THE LENS WAS NOTED TO BE IMPROPERLY SEATED IN THE CARTRIDGE, AND UPON INSPECTION, IT APPEARED DEFORMED AND DID NOT FIT CORRECTLY WITHIN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER, AND DEPLOYMENT PROCEEDED AS PLANNED. THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT¿S EYE; HOWEVER, THE LENS DID NOT CONTACT THE EYE. THE INJECTOR CARTRIDGE AND DELIVERY SYSTEM WERE INTACT, WITH NO CRACKS OR DAMAGE OBSERVED. THE PATIENT WAS NOT AFFECTED BY THE LACK OF DEPLOYMENT, AND THERE WAS NO INJURY TO THE PATIENT'S EYE. NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS (E.G., VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES) WERE REQUIRED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE DEVICE WAS DETERMINED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE COMPLAINT DEVICE WAS DISCARDED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120630 ↗
• InjuryNov 5, 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), MODEL DIB00 WAS INVOLVED IN A VITRECTOMY PERFORMED BY THE SURGEON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23483051 ↗
• MalfunctionAug 29, 2025Difficult to Insert; Difficult to Insert

  AFTER BEING FULLY INSERTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE), DIB00 MODEL INTRAOCULAR LENS (IOL) DID NOT STAY IN LENS SAC. THE SAME SURGERY WAS COMPLETED HOWEVER, IT IS UNKNOWN IF ANOTHER IOL WAS IMPLANTED. THERE WAS NO PATIENT INJURY. THE FOLLOWING ARE ALL UNKNOWNS: INCISION ENLARGEMENT, SUTURE(S), VITRECTOMY, AND PATIENT STATUS POST-PROCEDURE. 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 22929632 ↗
• MalfunctionAug 28, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) EXPERIENCED HAPTIC ENTANGLEMENT AND BECAME CONTORTED DURING PARTIAL DEPLOYMENT. THE LENS WAS SUBSEQUENTLY REMOVED, AND A BACKUP LENS WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. THE AFFECTED LENS WAS DISPOSED OF AND IS NO LONGER AVAILABLE FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913346 ↗
• MalfunctionMar 28, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT DURING HANDLING/PRIOR TO INSERTION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A SCRATCH ON THE LENS. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS A PARA CENTRAL DEFECT IN THE LENS, NOT JUST A SCRATCH. IT WAS LIKE A U SHAPED DIVOT. IT HAD NOTHING TO DO WITH THE INSERTION PROCESS. THE IOL HAD TO BE CUT OUT TO REMOVE IT FROM THE PATIENT'S OPERATIVE EYE AND REPLACED DURING THE SAME SURGERY. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE LENS IS NOT AVAILABLE FOR RETURN AS IT WAS CUT INTO PIECES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722787 ↗
• MalfunctionJan 6, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) BECAME STUCK DURING THE INSERTION ATTEMPT, LIKELY DUE TO A BENT OR BROKEN HAPTIC. AS A RESULT, THE INSERTION PROCESS WAS DEEMED UNSAFE & UNABLE TO SUCCESSFULLY INSERT THE LENS. THERE WAS PATIENT CONTACT. SUBSEQUENTLY, A NEW LENS WAS OPENED AND SUCCESSFULLY INSERTED INTO THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21088182 ↗
• MalfunctionJan 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAPTICS WERE STUCK TO THE LENS AND WOULD NOT SPONTANEOUSLY OPEN. THE ISSUE WAS OBSERVED RIGHT AFTER INSERTION INTO THE RIGHT EYE, VIEWED UNDER THE MICROSCOPE. THE SURGEON HAD TO MANUALLY PRY THE HAPTICS WITH THE KUGLEN MANIPULATOR FOR THEM TO UNFOLD. THERE WAS NO POST-OPERATIVE COMPLICATIONS. BALANCED SALT SOLUTION (BSS) WAS USED AT ROOM TEMPERATURE. THERE WERE NO DELAYS IN SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS AFTER THE INSERTER WAS PREPPED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055876 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO REFRACTIVE SURPRISE. THE REPLACEMENT LENS MODEL WAS A DIU150 +17.5 IOL. THERE WAS NO UNPLANNED INCISION ENLARGEMENT AND NO SUTURES. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20530124 ↗
• MalfunctionOct 1, 2024Use of Device Problem; Ejection Problem; Use of Device Problem; Ejection Problem

  IT WAS REPORTED THAT DURING THE SURGERY, SURGEON ADVANCED THE PRELOADED MONOFOCAL LENS PREMATURELY AND THE LENS COULDN'T BE RELOADED. A NEW LENS OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED WITHOUT ANY ISSUES. NO PATIENT INJURIES OR MEDICAL INTERVENTIONS OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348248 ↗
• MalfunctionApr 2, 2024Contamination; Contamination

  IT WAS REPORTED THAT A POSTERIOR CAPSULAR OPACIFICATION (PCO)- LIKE FILM WAS ON THE ACTUAL LENS. THE LENS WAS LOADED CORRECTLY, BUT AGAIN APPEARS MORE OF THAT CARTRIDGE COATING IS GETTING ON THE OPTIC. THE LENS WAS HYDRATED WITH VISCOELASTIC INSTEAD OF BALANCED SALINE SOLUTION (BSS) AND IT DID NOT HAVE THE RESIDUE. IT WAS NOTED THAT THE PCO - LIKE FILM WAS NOT VISIBLE AT ALL WHEN HYDRATED WITH VISCOELASTIC. THE LENS REMAINS IMPLANTED. NO PATIENT IMPACT POST OP OR NEGATIVE EFFECTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021131 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) MONOFOCAL INTRAOCULAR LENS IS BEING RETURNED DUE TO "PATIENT ISSUES". NO FURTHER DETAILS WERE PROVIDED AND THE EVENT IS BEING REPORTED CONSERVATIVELY REASONING THAT THIS RETURN IS AN EXPLANT BASED ON THE UNKNOWN PATIENT ISSUES.

  Patient problems: Eye Injury

  MAUDE report 18975500 ↗
• MalfunctionNov 28, 2023Scratched Material; Scratched Material

  IT WAS REPORTED UPON IMPLANTATION OF THE DIB00 MODEL INTRAOCULAR LENS (IOL), A SCRATCH WAS NOTED ON THE LENS POSSIBLY CAUSED BY THE INSERTER TIP. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS INJURY, NO SUTURE(S), AND NO VITRECTOMY. SINCE THE IOL WAS WELL CENTERED AND THE DEFECT/SCRATCH WAS NOT IN THE VISUAL CENTER, IT WAS DECIDED TO LEAVE THE IOL IN PLACE RATHER THAN TO EXCHANGE IT DUE TO THE PATIENTS RESTLESSNESS DURING THE PROCEDURE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS POST-OP VISIT ONE, PATIENT WAS HAPPY WITH THE RESULTS AND THE ARTIFACT/SCRATCH DID NOT APPEAR TO EFFECT THE PATIENT'S VISION. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222662 ↗
• MalfunctionOct 30, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH WHEN THE SURGEON WAS IMPLANTING IT. THERE WAS PATIENT CONTACT BUT THE ISSUE WAS NOTICED PRIOR TO INSERTION. THE STAFF THREW AWAY THE LENS AND CANNOT FIND IT DUE TO IT BEING BROKEN INTO MULTIPLE PIECES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036175 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS WASTED DUE TO DEFECTIVE. THE PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761035 ↗
• MalfunctionSep 1, 2023Break; Break

  IT WAS REPORTED THAT TECNIS SIMPLICITY TECNIS EYHANCE PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS BENT. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672730 ↗
• MalfunctionAug 16, 2023Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD "CARTRIDGE SIDES BREAKS" WHICH OCCURRED DURING IMPLANTATION INTO THE RIGHT EYE. ONLY THE CARTRIDGE TIP WAS IN CONTACT WITH THE PATIENT'S EYE. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO DELAY IN PROCEDURE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE CARTRIDGE TIP WAS DAMAGED. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557743 ↗
• MalfunctionAug 1, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THE PRE-LOADED MODEL INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THE IOL WAS NOT IN THE INJECTOR PROPERLY. IT WAS INDICATED THE ISSUE OCCURRED DURING IMPLANTATION AND THERE WAS NO PATIENT INVOLVEMENT HOWEVER, IT WAS ALSO STATED THAT CONTACT WITH PATIENT'S EYE IS UNKNOWN. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438274 ↗
• MalfunctionJul 24, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE FURTHER DOWN THE CHANNEL. THROUGH FOLLOW-UP THE DOCTOR EXPLAINED THE SURGICAL SCRUB PLACED BALANCED SALT SOLUTION (BSS) IN THE DELIVERY AREA OF THE LENS IMPLANTATION DEVICE AND PARTIALLY ADVANCED THE LENS. THEN THE DOCTOR ADVANCED THE LENS FURTHER DOWN THE DELIVERY CHANNEL. AS THE LENS ADVANCED DOWN THE CHANNEL, IT REACHED A POINT WHERE IT WOULD NOT ADVANCE FURTHER, EVEN WITH A MUCH HIGHER AMOUNT OF FORCE THAN IS NORMALLY USED. MORE BSS WAS ADDED BUT THE IMPLANT STILL WOULD NOT PASS FURTHER DOWN THE CHANNEL. AT THAT POINT, THE DOCTOR ASKED FOR THE SPARE LENS, AND IT WAS EASILY IMPLANTED INTO THE EYE. FURTHER FEEDBACK FROM THE CUSTOMER CONFIRMED THE ISSUE WAS NOT LENS DAMAGED BUT AN ADVANCEMENT ISSUE. THE LENS REACHED A POINT WHERE IT WOULDN¿T MOVE. THE IOL DID NOT TOUCH THE EYE. ONLY THE CARTRIDGE HAD CONTACT. THERE WERE NO OTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386147 ↗
• MalfunctionJul 22, 2023Break; Ejection Problem; Break; Ejection Problem

  THE SURGERY CENTER INITIALLY REPORTED LENS DEFECT WITH AN INTRAOCULAR LENS (IOL) AND THAT LENS WAS STUCK IN THE CARTRIDGE. ADDITIONAL INFORMATION CLARIFIED THE LENS ITSELF WAS DAMAGED, THAT THE IOL WAS PARTIALLY DELIVERED INTO THE PATIENT¿S RIGHT EYE AND THERE WAS CONTACT WITH THE LENS. NO SECOND INSTRUMENT NEEDED OR CHANGE OF PLAN REQUIRED. ANOTHER JOHNSON AND JOHNSON LENS WITH THE SAME MODEL AND DIOPTER WAS USED AS A REPLACEMENT. NO SURGICAL AND/OR MEDICAL INTERVENTIONS WERE REPORTED. THE PATIENT IS DOING FINE POST-OP AND NO INJURY REPORTED. IT WAS INDICATED THAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS USED AS THE LUBRICANT WHICH WAS INTRODUCED INTO THE CARTRIDGE FROM CARTRIDGE CANOPY. IT WAS CONFIRMED THAT THE LENS WAS NOT FOLDED WITHIN THE CARTRIDGE FOR MORE THAN 10 MINUTES BEFORE IT WAS DELIVERED INTO THE PATIENT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375726 ↗
• MalfunctionJul 17, 2023Scratched Material; Scratched Material

  IT IS REPORTED THAT DIB00 INTRAOCULAR LENS HAD A SCRATCH/DEFECT IN THE CENTER AND WAS OBSERVED AFTER IMPLANTATION. DOCTOR DECIDED THE SCRATCH WAS NOTICEABLE SO HE CUT THE LENS AND REMOVED IT. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17333552 ↗
• MalfunctionJun 19, 2023Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CARTRIDGE BROKE/CRACKED WHILE INSERTING INTO THE PATIENT¿S EYE. ONLY THE CARTRIDGE TOUCHED THE PATIENT¿S EYE AND THE LENS WAS NOT INSERTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER IOL. THE LENS WAS RECEIVED FOR EVALUATION AND IT WAS CONFIRMED THAT THE CARTRIDGE TIP WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158135 ↗
• MalfunctionSep 6, 2022Crack; Crack

  IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE CARTRIDGE OF THE PRELOADED DEVICE WAS CRACKED WHILE INSERTING INTO PATIENT'S LEFT EYE. ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE EYE. THE DEVICE WAS REMOVED AND A NEW INTRAOCULAR LENS (IOL) WAS OPENED. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366843 ↗
• MalfunctionSep 1, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT OF THE WRONG SIDE OF THE INJECTOR. THE LENS WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT AND THE EVENT WAS OBSERVED UPON PRIMING OF THE LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342081 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) DUE TO POSTERIOR CAPSULAR RUPTURE DURING IRRIGATION AND ASPIRATION (I&A) AFTER IOL IMPLANTATION. VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14058687 ↗