TECNIS SIMPLICITY DIB00 (REF DIB00U0150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474731653), received between Aug 19, 2021 and May 29, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25333626 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FULLY INSERTED PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS CUT OUT AND REMOVED FROM A PATIENT¿S RIGHT EYE. FOLLOWING REMOVAL, A NON¿JOHNSON & JOHNSON THREE-PIECE IOL OF 14.5 DIOPTER WAS IMPLANTED AFTER AN UNPLANNED POST-VITRECTOMY PROCEDURE. THE COMPLAINT LENS WAS DISCARDED AFTER REMOVAL AND IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION INDICATED THAT A POSTERIOR CAPSULAR RUPTURE OCCURRED AFTER INSERTION OF THE COMPLAINT IOL, NECESSITATING REMOVAL OF THE LENS DURING THE SAME SURGICAL PROCEDURE AND REQUIRING AN UNPLANNED VITRECTOMY. THE LENS REMOVAL WAS NOT DUE TO PATIENT ANATOMY OR PRE-EXISTING CONDITIONS. NO DAMAGE WAS OBSERVED TO THE CARTRIDGE TIP OR TO THE OPTIC OR HAPTICS OF THE LENS. A THREE-PIECE IOL WAS REQUIRED DUE TO THE CAPSULAR RUPTURE. THE SURGEON DID NOT APPLY EXCESS FORCE DURING LENS DELIVERY. SUTURES WERE PLACED TO PREVENT INJURY AND WERE NOT PART OF THE SURGEON¿S STANDARD PRACTICE. AT THIS TIME, IT REMAINS UNDETERMINED WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24584887 ↗
• MalfunctionMar 2, 2026Contamination

  UNDER A MICROSCOPE, AN ADDITIONAL PIECE OF ACRYLIC WAS OBSERVED ON THE DIB00 MODEL INTRAOCULAR LENS (IOL) AFTER ITS IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER IOL WITH THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION DURING THE PROCEDURE. PATIENT PROGNOSIS WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477708 ↗
• MalfunctionAug 1, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE LENS WAS WASTED DUE TO BEING LOADED INCORRECTLY DURING IMPLANTATION. ADDITIONAL INFORMATION REVEALED THAT THE LENS WAS INSERTED INTO THE EYE, DOCTOR REPORTED IT WAS LOADED INCORRECTLY, LENS REMOVED AND NEW LENS PLACED. THERE WAS NO HARM TO THE PATIENT AND PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690639 ↗
• MalfunctionJul 8, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED BY THE INJECTOR DURING THE PROCEDURE. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP LENS OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS SUCH AS A CAPSULE TEARS, VITRECTOMIES, OR SUTURES. THE CUSTOMER SUGGESTED THAT THE ISSUE MIGHT HAVE BEEN RELATED TO USE ERROR, AS BALANCED SALT SOLUTION WAS USED DURING THE PROCEDURE. HOWEVER, IT WAS CLARIFIED THAT THE USE OF BALANCED SALT SOLUTION IS CONSISTENT WITH THE DIRECTIONS FOR USE AND DOES NOT CONSTITUTE A USE ERROR. THE CUSTOMER ALSO MENTIONED THAT, FOLLOWING CONSULTATION WITH A JOHNSON AND JOHNSON REPRESENTATIVE, THE ISSUE STOPPED OCCURRING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437273 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT EYE HAD A TEAR IN THEIR CAPSULAR BAG. THE LENS WAS REMOVED AND REPLACED WITH A 3 PC LENS IN THE SAME PROCEDURE- THERE WAS NOTHING WRONG WITH THE INJECTOR OR LENS. THE LENS WAS IN THE PATIENT FOR LESS THAN 20 SECONDS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 21972256 ↗
• MalfunctionMar 26, 2025Device Difficult to Setup or Prepare; Mechanical Jam; Scratched Material; Device Difficult to Setup or Prepare; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE SHOOTER COULD NOT BE ADVANCED. THE TECHNICIAN ADVANCED THE LENS FOR THE DOCTOR BUT NOTICED A LOT OF RESISTANCE. SHE INFORMED THE DOCTOR OF THE RESISTANCE AND THEN HANDED THE DEVICE TO THE DOCTOR. THE DOCTOR ALSO FELT RESISTANCE AND FELT UNCOMFORTABLE USING THE DEVICE. THE SURGEON DECIDED NOT TO USE THE PRODUCT. THE PRODUCT WAS STUCK IN THE CARTRIDGE AND DID NOT HAVE ANY PATIENT CONTACT. THE TECHNICIAN PUSHED THE IOL THRU IN THE STERILE FIELD. WHEN THEY EXAMINED THE IOL UNDER A MICROSCOPE, THEY NOTICED A SCRATCH. THEY CANNOT TELL IF THE SCRATCH WAS ALREADY THERE PRIOR TO ADVANCING THE LENS. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY INCISION ENLARGEMENT OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701904 ↗
• MalfunctionNov 22, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) PLUNGER WENT STRAIGHT THROUGH THE LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764632 ↗
• MalfunctionAug 23, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) BOX IS DAMAGED AND THE WHITE SEAL IS SLIGHTLY BROKEN. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. IT IS UNKNOWN IF THE OUTER PACKAGING WAS SEALED, AND IT IS UNKNOWN IF THE STERILITY OF THE INNER PACKAGE/INNER POUCH COMPROMISED BECAUSE OF THIS ISSUE. IT WAS CONFIRMED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS AND THERE WAS NO PATIENT INJURY. THE SHIPPING BOX IS NOT AVAILABLE AS IT WAS DISPOSED OF. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056301 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND REMOVED DURING THE SAME PROCEDURE LENS WAS DAMAGED AND CRACKED AND REPLACED WITH THE SAME MODEL AND SAME DIOPTER LENS. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION AND APPLICATION OF THE LENS. THE BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OP WAS 20/40. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO USE ERROR. 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 18995333 ↗
• MalfunctionMar 23, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS WAS BEING PLACED IN THE EYE WHEN DOCTOR NOTICED A SMALL PIECE OF FOREIGN MATTER ON THE LENS. THE MATTER WAS DESCRIBED AS A BLACK FLECK. THE LENS WAS IMPLANTED INTO THE EYE BEFORE THEY NOTICED THE FOREIGN MATERIAL SO THE LENS WAS THEN CUT IN HALF AND REMOVED FROM THE EYE. IT WAS REPLACED WITH ANOTHER JNJ LENS OF THE SAME POWER. THE DOCTOR EXPRESSED THAT IT WAS ODD AND THEY'VE NEVER SEEN ANYTHING LIKE THAT IN THE PRELOADED DEVICE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES. THE PATIENT IS DOING WELL WITHOUT ANY ILL AFFECT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965841 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT THE TECNIS SIMPLICITY EYHANCE PRE-LOADED INTRAOCULAR LENS (IOL) WAS FRACTURED PER SURGEON WHICH WAS NOT RELATED TO USE ERROR. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034382 ↗
• MalfunctionJun 6, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAS A SCRATCH. THE SCRATCH WAS NOTICED AFTER THE IOL WAS IMPLANTED. THE IOL WAS LEFT IN THE EYE AND WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. DOCTOR WILL TAKE ACTION IF IT PROVES PROBLEMATIC. DOCTOR IS IN FOURTH YEAR OF RESIDENCY. REPORTEDLY THERE WAS NO SURGICAL OR MEDICAL INTERVENTION SUCH AS YTTRIUM-ALUMINUM GARNET LASER TREATMENT (YAG), EXPLANT OR LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17068118 ↗
• MalfunctionJun 7, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) LOOKED LIKE IT WAS FUSED TOGETHER AT THE TIP OF THE DEVICE AND WOULD NOT ALLOW THE LENS TO COME OUT. THERE WAS NO PATIENT CONTACT AND THE EVENT WAS OBSERVED DURING HANDLING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628667 ↗
• MalfunctionApr 15, 2022Crack; Inaccurate Delivery; Crack; Inaccurate Delivery

  IT WAS REPORTED THAT AN EYHANCE CARTRIDGE WAS DEFECTIVE AS THE INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE. EVENTUALLY THE CARTRIDGE SPLIT OPEN. A BACKUP EYHANCE IOL WAS SUCCESSFULLY IMPLANTED. THROUGH FOLLOW-UP THE DOCTOR EXPLAINED THAT THE INJECTOR MADE A "CLICKING" SOUND AS THE DIAL WAS TURNED AND THE LENS WAS BEING ADVANCED INTO THE EYE. AS THE LENS APPROACHED THE OUTLET OF THE CARTRIDGE, THE CARTRIDGE BROKE AT ITS TIP. THIS WAS WITHDRAWN FROM THE EYE WITHOUT ANY INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121578 ↗
• MalfunctionApr 15, 2022Break; Break

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND WASTED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119477 ↗
• MalfunctionNov 8, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED DURING PRODUCT HANDLING AND PRIOR TO INSERTION THE PRE-LOADED INTRAOCULAR LENS (IOL), THE LENS WAS STUCK IN THE CARTRIDGE AND HAPTIC WAS GETTING CRUSHED; THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS AND/OR HAPTICS WAS DAMAGED IN THE PRE-LOADED DEVICE PRIOR TO PATIENT CONTACT AND THE SAME MODEL AND DIOPTER BACKUP LENS WAS USED WITH NO ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12776084 ↗
• MalfunctionAug 19, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A DIB00 MODEL INTRAOCULAR LENS(IOL) HAD BAD HAPTIC AND WOULD NOT ADVANCE. THE LENS DID NOT TOUCH/CONTACT THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY. NO MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL DETAILS RECEIVED CONFIRMS THAT HAPTIC WAS DAMAGED AND THE LENS DID NOT ADVANCE FROM STAGING PHASE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340723 ↗