TECNIS SIMPLICITY DIB00 (REF DIB00U0120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474731592), received between Mar 15, 2022 and Mar 23, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT UPON OPENING THE PRODUCT PACKAGING, THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS FOUND TO BE MALFUNCTIONING. NO PATIENT CONTACT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664146 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT THE IMPLANTED LENS WAS CRACKED AND HAD PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913659 ↗
• MalfunctionMay 16, 2025Break; Crack; Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Jam; Operating System Becomes Nonfunctional; Break; Crack; Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Jam; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT WHEN ADVANCING THE PRELOADED INTRAOCULAR LENS (IOL), THE DOCTOR FELT RESISTANCE AND IT WAS INCREASINGLY DIFFICULT THEN THE LENS STARTED TO BULGE OUT OF THE SIDE OF THE CARTRIDGE. THE CARTRIDGE TIP WAS IN CONTACT WITH PATIENT'S EYE. THE PROCEDURE WAS COMPLETED WITH DIB00 LENS WITH 11.50 DIOPTER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039594 ↗
• MalfunctionMay 15, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON HAD NOTICED A SCRATCH/DIVOT ON THE PRELOADED INTRAOCULAR LENS (IOL) ONCE IT WAS IMPLANTED. THE LENS WAS SUBSEQUENTLY CUT OUT REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THE TECH DIDN¿T NOTICE ANYTHING WHILE ADVANCING BUT THE SURGEON SAID HE DID NOTICE SOME RESISTANCE WHEN HE BEGIN ADVANCING THE PLUNGER AND THE DIVOT WAS ONLY NOTICED ONCE IMPLANTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030780 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE SUSPECT IOL WAS EXPLANTED DUE TO UNKNOWN REASONS AND THE EXPLANTED IOL WAS REPLACED WITH A ZA9003 12.0 DIOPTER IOL. THERE WAS NO VITRECTOMY REQUIRED DURING THE LENS EXCHANGE PROCEDURE. IT IS UNKNOWN IF MEDICAL ATTENTION WAS REQUIRED OR IF MEDICATION WAS PRESCRIBED (OUTSIDE OF STANDARD CARE). PATIENT STATUS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 20636959 ↗
• MalfunctionNov 21, 2023Material Split, Cut or Torn; Ejection Problem; Material Split, Cut or Torn; Ejection Problem

  IT WAS REPORTED THAT THE PATIENT MOVED DURING THE IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, CAUSING MISFIRE AND THE LENS TORE WHILE REMOVING FROM OPENING. THERE WAS PATIENT CONTACT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF ANY PATIENT INJURY. A BACK-UP LENS WAS USED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PROCEDURE NOTE FROM THE SURGEON DOES NOT DISCLOSE ANY ADDITIONAL INFORMATION, ONLY THAT ANOTHER LENS WAS OPENED AND PLACED. THERE IS NO NOTATION THAT THE TORN IMPLANT WAS PLACED IN ANY PART OF THE EYE ITSELF OR WHEN OR HOW IT WAS DAMAGED. THE ONLY STATEMENT THAT THE SURGEON MADE WAS DURING THE PROCEDURE WHEN IT WAS STATED THAT IT WAS TORN AND NEEDED TO BE REPLACED BECAUSE THE PATIENT MOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183476 ↗
• InjuryMay 12, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH. THE IOL WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE. UPON INSERTION THE LENS WAS NOTICED TO HAVE A ¿SPOT¿ WHICH CUSTOMER CLARIFIED TO BE A SCRATCH ON THE LENS. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO A SCRATCH, DIVET OR DEFECT IN THE CENTER OF THE IOL. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT. THE OUTCOME DOES NOT INTERFERE WITH ACTIVITIES OF DAILY LIFE. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED OR IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925025 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH BILATERAL INTRAOCULAR LENSES (IOLS) VISITED HIS DOCTOR¿S OFFICE ON (B)(6) 2022, AND THE PATIENT WAS TOLD THAT BOTH LENSES WERE CLOUDY AND WOULD HAVE TO BE REMOVED. PATIENT CANNOT SEE CLEARLY. PATIENT IS OCCASIONALLY TAKING DROPS FOR DRY EYE. THROUGH FOLLOW-UP, THE PATIENT EXPLAINED THAT HE WAS NOT ABLE TO SEE CLEAR AND THE DOCTOR TOLD HIM IT WAS DUE TO HIS POUCH BEING CLOUDY LIKE A CATARACT. THE PATIENT STARTED NOTICING THE BLURRY VISION RIGHT AFTER THE RIGHT EYE WAS DONE, MAY TIME FRAME. THEREFORE, A YTTRIUM ALUMINUM GARNET (YAG) WAS PERFORMED ON BOTH EYES ON (B)(6) 2022. THE PATIENT CONFIRMED THAT THE INITIAL REPORT "OF OCCASIONALLY TAKING DROPS FOR DRY EYE" WERE STANDARD OF CARE DROPS POST SURGERY. THE PATIENT STATED THAT HE HAS HAD A HISTORY OF DRY EYE AND THINKS IT WAS DUE TO HIS LASIK PROCEDURE PERFORMED SOMETIME IN 1998 PRIOR TO IOL IMPLANT. HE HAS OCCASIONALLY BEEN TAKING OVER-THE-COUNTER (OTC) EYE DROPS FOR DRY EYE. THE PATIENT ALSO HAS HAD TEAR DUCT PLUGS TO HELP WITH THE DRY EYES WHICH WERE PERFORMED SOMETIME IN JUNE OR JULY 2022. NO OTHER TREATMENTS HAVE BEEN PROVIDED AND THE LENSES REMAIN IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15577644 ↗
• MalfunctionApr 15, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS (IOL) DEVICE IS DEFECTIVE. A BRIEF DESCRIPTION OF THE EVENT REVEALED THAT THE PLUNGER BROKE THROUGH THE TIP AND CRACKED THE PLASTIC DURING ADVANCEMENT OF LENS. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE CARTRIDGE TIP WAS DAMAGED AND LENS WAS ALSO DAMAGED. THERE WAS NO PATIENT INJURY REPORTED AND NO INTERVENTION WAS REQUIRED. THE SAME PROCEDURE WAS COMPLETED USING A BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS UNKNOWN. THE IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. HOWEVER, THE SURGEON PROVIDED PHOTOGRAPHS OF THE SUSPECT DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121961 ↗
• MalfunctionMar 15, 2022Crack; Crack

  IT WAS REPORTED THAT UPON INSERTION, THE TIP OF PRELOADED INTRAOCULAR LENS (IOL) DEVICE WAS BROKEN. THE INCISION WAS ENLARGED, HOWEVER, SUTURES AND A VITRECTOMY WERE NOT REQUIRED. THE IOL WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE AS IT WAS NOT DEFECTIVE. IT TOOK EXTRA MANEUVERING USING MICRO-FORCEPS TO GET THE LENS POSITIONED CORRECTLY. THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13773022 ↗