TECNIS SIMPLICITY DIB00 (REF DIB00U0250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474731868), received between Jun 16, 2021 and Jun 1, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS LEFT EYE. AFTER THE IMPLANT THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON MODEL, RX LAL 23.5. THE PATIENT WAS NOT HARMED THEIR FINAL OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25352715 ↗
• InjuryOct 16, 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 OPERATIVE EYE. FOR UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, ALCON. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23319704 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A MYOPIC SURPRISE WITH A MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE. THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY. THE PATIENT'S STATUS WAS REPORTED AS UNKNOWN, AND NO FURTHER DETAILS REGARDING IMPAIRMENT OR RECOVERY WERE PROVIDED. THERE WAS NO INDICATION OF UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, AND NO DELAY IN THE PROCEDURE WAS REPORTED. THROUGH ADDITIONAL INFORMATION, IT WAS LEARNED THAT THE PATIENT WAS DISSATISFIED WITH THE DISTANCE VISION AND THE SURGEON HAD TARGETED -2.50 MYOPIC. THE LENS IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22786503 ↗
• MalfunctionMay 17, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WERE STUCK TOGETHER INSIDE THE EYE. THE DOCTOR HAD TO MANUALLY SEPARATE THEM. THERE WERE NO FURTHER COMPLICATIONS, AND HE WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040978 ↗
• MalfunctionMay 11, 2024Break; Break

  IT WAS REPORTED THERE WAS AN ISSUE WITH THE DIB00 MODEL INTRAOCULAR LENS (IOL) AND IT WAS NOT PUT INTO THE PATIENT. EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19295468 ↗
• MalfunctionJan 25, 2024Break; Crack; Mechanical Problem; Failure to Advance; Operating System Becomes Nonfunctional; Break; Crack; Mechanical Problem; Failure to Advance; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) INJECTOR FAILED AND THE LENS WAS DAMAGED. THE SURGEON STATED IT SEEMED THE PLUNGER WENT ON TOP OF THE LENS BEFORE GOING INTO THE EYE. THE TIP OF THE INJECTOR WAS SPLIT WHEN THE SURGEON TRIED TO FULLY EXPEL THE LENS. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE NURSE LOADED THE IOL AS STANDARD AND IT DIDN¿T GO INTO THE EYE. IT WAS ALSO REPORTED THERE WAS A PLUNGER ROD ISSUE AND THERE WAS NO PATIENT CONTACT. THE ISSUE WAS OBSERVED PRIOR TO INSERTION. THE LENS IS NOT AVAILABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584949 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD CATARACT SURGERY (B)(6) 2022 AND WAS UNHAPPY WITH THE LENS DUE TO THEM EXPERIENCING BLURRY VISION AND HALOS. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THERE WAS NO INCISION ENLARGEMENT, SUTURES, VITRECTOMY AND NO DELAY IN PROCEDURE. REPORTEDLY, THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16401741 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING POSITIVE AND NEGATIVE DYSPHOTOPSIA WITH INTRAOCULAR LENS (IOL) IN HER RIGHT EYE POST IOL IMPLANT. THE PATIENT DESCRIBED EXPERIENCING A VIBRATION IN HER EYE SINCE SURGERY. SHE SAID IT IS NOT VISIBLE TO SOMEONE LOOKING AT HER. IT IS RELATED TO HOW HER EYE IS CATCHING THE REFLECTION OF LIGHT WITH THE NEW LENS. SHE FEELS HER BRAIN IS NOT ADAPTING TO THE NEW LENS. SHE STATED SHE SEES DARK SPOTS THAT ARE MORE LIKE MAGNIFIED WATER DROPLETS OR BLACK LINES WITH A HALO BEHIND IT. THE PATIENT SEES AS A GHOST IMAGE ON HER LEFT SIDE, THAT IS NOT JUST IN THE CORNER, BUT CLOSER TO THE INSIDE TOO. WHEN SHE BLINKS IT FEELS LIKE IT IS OUT OF FOCUS. SHE SAID IT IS NOT, DOUBLE VISION, BUT A GHOST VISION. THIS MAKES HER FEEL ANXIOUS AND DIZZY. SHE IS CONCERNED ABOUT DRIVING. SHE SAID SHE CAN DRIVE, BUT DOES NOT FEEL COMFORTABLE DOING SO BECAUSE THE ABERRATIONS MAKE HER FEEL LIKE SHE CAN NOT SEE. THE PATIENT MENTIONED SHE EXPERIENCED A LOT OF EDEMA AFTER SURGERY. SHE SPOKE TO HER DOCTOR, WHO SAID THE LENS IS ATTACHED CORRECTLY AND SHE IS HEALING PERFECTLY. HE DID NOT KNOW WHAT WAS CAUSING HER VISUAL DISTURBANCES, BUT WAS GOING TO REACH OUT TO JOHNSON & JO

  Patient problems: Blurred Vision; Flashers; Halo; Insufficient Information; Swelling/ Edema; Visual Disturbances

  MAUDE report 14350294 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE OF THE PRELOADED INTRAOCULAR LENS DEVICE BROKE/ CRACKED. THERE WAS PATIENT CONTACT ONLY WITH THE CARTRIDGE. THE EVENT WAS OBSERVED WHILE INSERTING INTO THE EYE AND THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488727 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A TECNIS EYHANCE INTRAOCULAR LENS (IOL), MODEL DIB00, IMPLANTED IN THE LEFT EYE ON (B)(6) 2021 EXPERIENCED UNEXPECTED POST-OP REFRACTION. A BRIEF DESCRIPTION OF THE EVENT PROVIDED THAT THE PATIENT ENDED UP MYOPIC AND WAS NOT HAPPY WITH THE RESULTS. FOLLOW-UP WITH THE ACCOUNT REVEALED THAT THE SURGEON IMPLANTED A PIGGY-BACK JOHNSON AND JOHNSON IOL MODEL AR40M IN A SECONDARY PROCEDURE ON (B)(6) 2021. THERE WERE NO INJURIES REPORTED AND THE PATIENT IS DOING WELL. THE PATIENT HAS NOT RETURNED FOR FURTHER TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12333609 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DIB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO REFRACTIVE MISS AND ALSO DUE TO PATIENT COMPLAINING OF NOT BEING ABLE TO SEE DISTANCE WELL. SUTURES WERE PERFORMED AND NO OTHER MEDICAL/ SURGICAL INTERVENTIONS LIKE VITRECTOMY OR INCISION ENLARGEMENT WAS DONE. SYMPTOMS OF PATIENT SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITIES OF LIFE. ADDITIONAL DETAILS RECEIVED STATES THAT PATIENT HAD FLOATERS, VISION WAS BLURRY, SLIGHT PAIN AND HEADACHE. THE REPLACEMENT LENS USED IS A SAME MODEL BUT DIFFERENT DIOPTER LENS. PATIENT WAS DOING BETTER AFTER THE IMPLANTATION OF THE REPLACEMENT LENS. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): RIGHT EYE 20/50. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/50 WANTED 20/60 AND WEEK AND FEW DAYS LATER, (B)(6) 2021, NEGATIVE -2 SAW BETTER AT CLOSE THEN AT DISTANCE. WAS AIMING FOR DISTANCE. TARGET REFRACTIVE VALUE PRE-OP (PRE-INITIAL IMPLANT): 20/60. FINAL REFRACTIVE VALUE POST-OP (POST-INITIAL IMPLANT): NEGATIVE 2 SAW BETTER AT CLOSE THEN AT DISTANCE. WAS AIMING FOR DISTANCE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Eye Pain; Headache; Visual Impairment; Vitreous Floaters

  MAUDE report 12013743 ↗