TECNIS SIMPLICITY DIB00 (REF DIB00U0190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 05050474731738), received between Sep 10, 2021 and Sep 15, 2026 — classified as 16 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 60 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a preloaded Johnson & Johnson (J&J) intraocular lens (IOL) was successfully implanted in the patient's right eye. Subsequently, the IOL was explanted and replaced with another Johnson & Johnson IOL, model DRT150, +18.5 D. The reason for the explantation was not provided. The customer indicated that the lens was replaced as an "upgrade"; however, no additional details regarding this statement were available. According to the information received, the Directions for Use (DFU) were followed. No vitrectomy was required, and no delay or interruption of the surgical procedure was reported. No further intraoperative complications or interventions were reported. The patient's clinical outcome following the explantation and replacement procedure is unknown. Follow-up was conducted by J&J; however, no additional information regarding the reason for explantation, patient symptoms, or postoperative outcome was provided. No further relevant details are available.

  Patient problems: Eye Injury

  MAUDE report 50776658 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS CRACKED PRIOR TO IMPLANTATION. THE EVENT WAS OBSERVED DURING HANDLING / PRIOR TO INSERTION. NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112869 ↗
• MalfunctionFeb 9, 2026Material Fragmentation

  IT WAS REPORTED THAT A SINGLE-PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO BE DEFECTIVE DURING INSERTION, AS THE LEADING HAPTIC HAD POPPED OUT. ANOTHER IOL OF THE SAME MODEL AND DIOPTER WAS USED AS A BACKUP REPLACEMENT WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE IOL WAS NOT FULLY INSERTED INTO THE PATIENT'S LEFT EYE. ANOTHER IOL WAS USED AND IMPLANTED INSTEAD. NO FORCE WAS APPLIED TO DELIVER THE IOL. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A POSITIVE PATIENT OUTCOME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24297478 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS TORN OR THE HAPTIC PART WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE MALFUNCTION WAS OBSERVED PRIOR TO INSERTION. THERE WAS NO PATIENT INJURY. THE IOL AND CARTRIDGE DID NOT TOUCH THE EYE. A BACKUP IOL OF THE SAME MODEL WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THE PRODUCT IS NOT AVAILABLE TO RETURN SINCE CUSTOMER STATED THAT THEY DON'T HAVE IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214751 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE BECAUSE THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. IT IS UNKNOWN WHETHER THE ISSUE AFFECTED THE PATIENT¿S DAILY ACTIVITIES. THE REPLACEMENT LENS WAS THE SAME MODEL WITH A LOWER POWER (17.0D). IT IS UNKNOWN IF THE PROCEDURE WAS DELAYED OR WHETHER AN UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. IT IS ALSO UNKNOWN WHETHER THE PATIENT SOUGHT ADDITIONAL MEDICAL ATTENTION OR RECEIVED MEDICATION BEYOND THE STANDARD OF CARE. THE PATIENT OUTCOME STATUS WAS NOT PROVIDED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24104064 ↗
• MalfunctionDec 16, 2025Break; Crack; Break; Crack

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS DEFECTIVE, AND THE SURGEON WAS UNABLE TO GET THE SHOOTER INTO THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824391 ↗
• MalfunctionSep 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE EYE BUT WAS SUBSEQUENTLY REMOVED DUE TO THE HAPTIC BREAKING OFF AFTER INSERTION. THIS REQUIRED AN INCISION ENLARGEMENT. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. THERE WERE NO REPORTED PATIENT INJURIES, AND THE PATIENT¿S OUTCOME WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 23096236 ↗
• MalfunctionAug 20, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE LENS WAS USED AS A BACK UP LENS AFTER THE FIRST LENS WAS REMOVED (SERIAL (B)(6)). AFTER INSERTION, THE OPHTHALMOLOGIST OBSERVED DEBRIS ON THE LEADING EDGE, THOUGH IT WAS NOT PROMINENT. LENS WAS LEFT IN THE PATIENT'S EYE. NO INJURY OR FURTHER INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853166 ↗
• MalfunctionAug 20, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED INVOLVING THE INSERTION OF AN INTRAOCULAR LENS (IOL). AFTER INSERTION, THE OPHTHALMOLOGIST OBSERVED DEBRIS ON THE LEADING AND TRAILING EDGES OF THE LENS. DESPITE VARIOUS ATTEMPTS, THE DEBRIS COULD NOT BE SATISFACTORILY REMOVED, LEADING TO THE REMOVAL OF THE IOL BY BISECTING IT. A SECOND IOL OF THE SAME MODEL AND DIOPTER (SERIAL (B)(6) WAS THEN INSERTED. NO INJURY OR FURTHER INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853163 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS WAS NOT USED DUE TO VITRECTOMY. UPON FURTHER FOLLOW UP IT WAS STATED THAT THE LENS WAS EXPLANTED DUE TO THE VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22437226 ↗
• 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. BALANCED SALT SOLUTION (BSS) WAS USED IN THE INJECTOR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006393 ↗
• MalfunctionMay 9, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS KINKED, SO THE LENS COULD NOT ADVANCE FORWARD. THERE WAS NO PATIENT INJURY. THE DEFECTIVE PRODUCT WAS RECEIVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998411 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED IOL WAS DEFECTIVE AND WASTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965320 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED CORNEAL EDEMA, REQUIRED MEDICATION AND FACED DELAYED HEALING FOLLOWING LENS IMPLANTATION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Corneal Edema

  MAUDE report 21867726 ↗
• MalfunctionApr 17, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED LENS ENCOUNTERED RESISTANCE UPON INSERTION INTO THE EYE. THE LENS WAS REMOVED AND A NEW LENS WAS SUCCESSFULLY INSERTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862523 ↗
• MalfunctionApr 17, 2025Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) DID NOT DEPLOY WELL WITH THE INSERTER AND THE IOL DID NOT UNFOLD. THE IOL WAS INSERTED AND THEN REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859154 ↗
• MalfunctionMar 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED AND THEN REMOVED FROM THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646920 ↗
• MalfunctionJan 31, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A DEFECT IN IT NEAR THE NOZZLE, SO WHEN ADVANCING THE LENS DOWN THE CARTRIDGE THE PLASTIC STARTED TO BULGE OUT AND THE LENS BEGAN TO UNFOLD SLIGHTLY THROUGH THE OPENING ON THE SIDE OF THE CARTRIDGE. THE INJECTOR DID COME INTO CONTACT WITH THE PATIENT. ANOTHER JOHNSON & JOHNSON LENS WAS IMPLANTED WITHOUT INCIDENT. THERE WAS NO DELAY IN PROCEDURE. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284927 ↗
• MalfunctionJan 21, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FAULTY. THE LENS WAS SCRATCHED OR HAD A FAULTY HAPTIC. THE PATIENT IS DOING FINE. BACK UP LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO PATIENT. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE SCRATCH WAS NOTICED AFTER INJECTING THE LENS INTO THE EYE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21202124 ↗
• MalfunctionJan 3, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS BALLED UP IN THE CARTRIDGE. THE LENS WAS ALREADY IN THE PLUNGER AND WOULD NOT DEPLOY. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067839 ↗
• MalfunctionDec 26, 2024Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND HAD TO BE REMOVED FROM PATIENT'S RIGHT EYE AS THE PATIENT AS THERE WAS A GASH FOUND IN THE LENS AND A SCRATCH WAS NOTICED IN THE MIDDLE OF THE LENS. THE ISSUE WAS NOTICED AFTER INSERTION. THERE WAS NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS GOOD POST-OP. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS WAS REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER LENS IN THE SAME PROCEDURE. UPON UNFOLDING THE EYE THE DEFECTIVE WAS NOTICED. THE TRAILING HAPTIC DID NOT REQUIRE ANY MANIPULATION. THERE WAS NO USE ERROR. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021686 ↗
• InjuryDec 4, 2024Manufacturing, Packaging or Shipping Problem; Ejection Problem; Manufacturing, Packaging or Shipping Problem; Ejection Problem

  WHEN INSERTING THE PRELOADED DIB00 INTRAOCULAR LENS (IOL), IT WAS REPORTED TO HAVE BEEN RECEIVED UPSIDE DOWN INSIDE THE CARTRIDGE. THE DOCTOR HAD TO MANUALLY CORRECT THE LENS POSITION AND IOL WAS IMPLANTED IN THE PATIENT'S EYE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN. ATTEMPTS WERE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839827 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED OF SOMETHING IN THE EYE CAUSING INFLAMMATION IN THREE PATIENTS WHICH WERE IMPLANTED WITH THE MONOFOCAL INTRAOCULAR LENSES (IOLS). THAT DURING THE POST-OP EXAMINATION, THE DOCTOR NOTICED SOMETHING GOING ON WITHIN EYE. IT IS UNKNOWN IF THE ISSUE SIGNIFICANTLY AFFECTED PATIENTS' DAILY ACTIVITIES. TREATED WITH STEROIDS AND CONTINUED EVALUATION OF EYE. ON 11/11/2024, THE DOCTOR CONFIRMED THAT ALL PATIENTS ARE DOING WELL AND RECOVERING FROM POST-OP IRITIS RECURRENCE. NO PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO PATIENT #2. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER TWO PATIENTS.

  Patient problems: Uveitis

  MAUDE report 20806004 ↗
• MalfunctionNov 27, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRE-LOADED LENS WAS INCORRECTLY LOADED INTO THE PRODUCT INJECTOR AND INSERTED INTO THE EYE, CAUSING THE HAPTIC TO TWIST. THIS WAS NOTICED DURING THE INSERTION INTO THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800556 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) WAS WASTED BECAUSE THE LENS BROKE WHEN ENGAGED. THEY BELIEVE THIS OCCURRED BECAUSE THE DEFECT LENS INSERTER BROKE THE LENS. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS WITH THE SAME MODEL AND DIOPTER. THERE WERE NO PATIENT COMPLICATIONS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657433 ↗