TECNIS SIMPLICITY DIB00 (REF DIB00U0245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474731851), received between Sep 27, 2021 and Aug 27, 2025 — classified as 6 injuries, 9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS WAS WASTED DUE TO CAPSULE RUPTURE. ADDITIONAL INFORMATION INDICATED THAT THE DETAILS WERE NOT RECORDED, AND THE LENS WAS DISPOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22909406 ↗
• MalfunctionJul 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LENS HAD A TRAILING HAPTIC SEVERED DURING INSERTION. THE LENS WAS FULLY INSERTED AND REMAINS IN THE EYE, APPEARING TO BE POSITIONED WELL. THE PATIENT HAS BEEN INFORMED, AND THE DOCTOR IS MONITORING THE SITUATION. ADDITIONAL INFORMATION REVEALED THAT THERE WAS NO USER ERROR, AND THE PATIENT IS DOING WELL. NO MEDICAL INTERVENTIONS OR INJURIES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613225 ↗
• MalfunctionMar 5, 2025Crack; Crack

  A COMPLAINT WAS REPORTED REGARDING THE DIB00 CARTRIDGE TIP, WHICH CRACKED DURING LENS INSERTION. AS THE LENS IS ADVANCED, THE CARTRIDGE TENDS TO CRACK NEAR THE TIP, RAISING CONCERNS ABOUT POTENTIAL INJURY TO PATIENT. DESPITE THE CRACK, THE LENS WAS SUCCESSFULLY IMPLANTED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT. IT WAS INDICATED THAT THE SURGEON HAS EXPERIENCED ADDITIONAL SIMILAR INCIDENTS. NO FURTHER INFORMATION WAS PROVIDED. TROUGH FOLLOW UPS, THE ACCOUNT MENTIONED THAT THEY USE BALANCED SALT SOLUTION (BSS) AT ROOM TEMPERATURE, WHICH IS INTRODUCED FROM THE CARTRIDGE CANOPY. THEY DO NOT OPEN THE LENS UNTIL THE END OF PHACOEMULSIFICATION; AT THAT POINT, THEY OPEN THE LENS AND PREPARE IT FOR USE. THE DWELL TIME IS 3 TO 4 MINUTES, AND THE SURGICAL TECHNICIAN PERFORMS THE INITIAL ADVANCEMENT. THE TECHNICIAN BELIEVES THAT THE DOCTOR APPLIES A ¼ TWIST DURING THE ADVANCEMENT PROCESS. IT WAS CONFIRMED THAT THERE HAVE BEEN NO INJURIES IN ANY OF THE CASES, NO INTERVENTIONS HAVE BEEN REQUIRED, AND THE LENSES HAVE BEEN SUCCESSFULLY IMPLANTED AND REMAIN IN PLACE TO DATE. ADDITIONALLY, THE PATIENTS OUTCOME HAVE BEEN GOOD. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT PERTAINS TO THE L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532107 ↗
• InjuryDec 6, 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 REMOVED AND REPLACED WITH SULCUS LENS IN THE SAME PROCEDURE AS THERE WAS POSTERIOR CAPSULE TEAR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 20869903 ↗
• MalfunctionNov 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS MALFUNCTIONED AFTER INSERTING INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658641 ↗
• MalfunctionOct 8, 2024Break; Break

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN WASTED DUE TO A DEFECTIVE HAPTIC. THERE WAS NO PATIENT CONTACT WITH THE DIB00 IOL. A BACK-UP DIB00 24.5 DIOPTER IOL WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DURING THE PROCEDURE THERE WAS NO INCISION ENLARGEMENT, SERIOUS PATIENT INJURY, NO SUTURE(S), NOR VITRECTOMY. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS SURGERY COMPLETED WITH NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20404310 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE AS THE PATIENT STATED HE HAD BLURRY VISION UNABLE TO ADAPT TO LENS. THE PATIENT WAS UNHAPPY WITH THE RESULTS OF VISION. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL, BUT LOWER DIOPTER (+23.5D). THERE WERE NO MEDICAL AND/OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 19621010 ↗
• MalfunctionJun 18, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) FELL OUT OF THE CARTRIDGE AND TOUCHED THE PATIENT'S EYE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE TECHS HAD CONFIRMED THERE WAS A PRODUCT ISSUE. THE ISSUE WAS NOTICED DURING IMPLANTATION OF THE LENS. THE PROCEDURE WAS COMPLETED WITH A BACK UP LENS, WITH THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY. BSS (BALANCED SALT SOLUTION) WAS USED AS A CARTRIDGE LUBRICANT AT ROOM TEMPERATURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564056 ↗
• InjuryMay 23, 2024Adverse 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) IS SCHEDULED FOR AN IOL EXCHANGE DUE TO THE PATIENT EXPERIENCING RESIDUAL ASTIGMATISM AND BLURRY VISION IN THE RIGHT EYE. THROUGH FOLLOW UP IT WAS LEARNED THAT A COMPLICATION AROSE DURING THE LENS EXCHANGE PROCEDURE. THE EXPLANT WAS PERFORMED, HOWEVER, A NEW LENS WAS NOT INSERTED IN THE PATIENT'S EYE. THE PATIENT WAS LEFT APHAKIC. NO FURTHER INFORMATION WAS PROVIDED. FURTHER INFORMATION WAS PROVIDED ON (B)(6) 2024, EXPLAINING THE COMPLICATION THAT AROSE DURING THE LENS EXCHANGE PROCEDURE. IT WAS LEARNED THAT THE OLD IOL HAPTIC WAS TOO ADHERENT TO THE CAPSULAR BAG. ONE HAPTIC WAS AMPUTATED DUE TO EXCESSIVE CAPSULAR FIBROSIS AROUND THE HAPTIC. THERE WAS NO PATIENT INJURY AND THERE WAS NO DEFECT ON THE IOL. NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE LENS IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 19388816 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE IT WAS OPEN UNUSED. THE HOOK WAS STUCK UNDERNEATH THE LENS AND IT WOULD NOT COME OUT. IT WAS NOTED THAT ANOTHER IOL OF THE SAME SIZE WAS USED. CONTACT PERSON STATED THAT IOL WAS DEFECTIVE STRAIGHT OUT OF THE PACKAGE, AND THAT IT WAS CAUGHT BEFORE PATIENT CONTACT. SUSPECT IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19252488 ↗
• InjurySep 11, 2023Adverse 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) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE. THE REPLACEMENT IOL WAS ANOTHER DIFFERENT MODEL OF J&J MONOFOCAL INTRAOCULAR LENS. THE PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17726396 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DIB00 INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S LEFT EYE IN SECONDARY SURGICAL PROCEDURE AS THE PATIENT WAS UNHAPPY WITH THE READING VISION. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT WAS EXPERIENCING DYSPHOTOPSIAS POST OPERATIVELY AFTER THE INITIAL IMPLANT WITH DIB00 LENS. DURING THE EXPLANT, DIB00 LENS OF 24.5 DIOPTER WAS REPLACED WITH ZCB00 LENS OF 19 DIOPTER. THE PATIENT WAS STABLE WITH RESOLVED SYMPTOMS AND NO OTHER SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17251667 ↗
• MalfunctionMar 20, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) UNRAVELED BEFORE IMPLANTATION. THERE WAS PATIENT CONTACT. IT WAS NOTED THAT THE LENS WAS NOT REMOVED/REPLACED IN THE SAME PROCEDURE NOR WAS IT REMOVED IN A SECONDARY PROCEDURE. THERE WAS NO DELAY IN PROCEDURE. NO SUTURE, INCISION ENLARGEMENT, OR VITRECTOMY WAS REQUIRED. THERE IS NO PLANNED EXPLANT. LENS DAMAGED WAS NOTED IN THE SOURCE EMAIL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577079 ↗
• MalfunctionJul 13, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE PLUNGER OF THE PRELOADED DEVICE OVERRODE THE INTRAOCULAR LENS (IOL) AND BENT THE HAPTIC. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007705 ↗
• MalfunctionSep 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A FIBER WRAPPED AROUND IT AND THERE WAS PATIENT CONTACT WITH THE FIBER AND LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536967 ↗