TECNIS SIMPLICITY DIB00 (REF DIB00U0125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474731608), received between Sep 10, 2021 and May 16, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Break; Mechanical Jam; Break; Mechanical Jam

  DURING DEPLOYMENT BUT PRIOR TO PATIENT CONTACT, THE DIB00 MODEL INTRAOCULAR LENS (IOL) CRUSHED-UP AND WAS STUCK IN THE TIP OF THE CARTRIDGE. BALANCED SALT SOLUTION (BSS) WAS USED AND THERE WAS NO DELAY BEFORE DEVICE HANDOFF TO THE DOCTOR. THERE WAS NO DEFECT TO THE DEVICE OR THE TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. THE SUSPECT IOL IS AVAILABLE FOR RETURN HOWEVER, THE DELIVERY SYSTEM IS NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040883 ↗
• MalfunctionApr 25, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT WHEN PRELOADED INTRAOCULAR LENS (IOL) LENS WAS INJECTED INTO THE EYE IT DID NOT INSERT AND WAS STUCK. THE LENS WAS PARTIALLY INSERTED AND REMOVED AS IT WAS DAMAGED. A BACK UP LENS WAS USED. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912074 ↗
• InjuryJan 27, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED AND SUBSEQUENTLY REPLACED WITH A NEW LENS. THE SURGEON WAS INJECTING THE MONOFOCAL INTRAOCULAR LENS (IOL) AND HEARD A CRACK WHILE WAS INJECTING THE LENS, BUT THE LENS WAS ALREADY IN THE EYE. THERE WAS A SCRATCH ON THE OPTIC CENTER AND THE SURGEON COULD NOT RUB IT OFF. THERE WAS IATROGENIC IRIS DAMAGE AND BLEEDING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; Hyphema

  MAUDE report 21248668 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120607 ↗
• MalfunctionSep 11, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A SCRUB TECH PREPARED THE INTRAOCULAR LENS (IOL) FOR INSERTION. MD ATTEMPTED TO IMPLANT IOL. IOL UNLOADED ITSELF FROM CARTRIDGE. LENS REMOVED. NEW IOL IMPLANTED WITH NO FURTHER ISSUES. IT WAS STATED THAT THERE WAS NO STUCK IN CARTRIDGE. THERE WAS NO INCISION ENLARGEMENT AND VITRECTOMY. NO SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT FULLY RECOVERED. IT WAS LEARNED THAT THE IOL WAS LOADED INTO OUR INSERTER INSTRUMENT. THE IOL ITSELF ONLY MADE PATIENT CONTACT, BUT NO FULL INSERTION OCCURRED. THE SCRUB TECH HANDED PRELOADED IOL TO THE SURGEON. THE TIP OF THE PRELOADED INSERTER WAS INSERTED INTO THE PATIENT'S RIGHT EYE. THE SURGEON ATTEMPTED TO ADVANCE THE IOL INTO PATIENT'S RIGHT EYE. UPON DOING SO, THE LENS UNLOADED ITSELF FROM THE PRELOADED DEVICE. A NEW PRELOADED IOL DEVICE WAS OPENED AND HANDED TO THE SURGEON. THE NEW LENS WAS SUCCESSFULLY INSERTED WITH NO FURTHER PROBLEMS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196724 ↗
• MalfunctionAug 20, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE RIGHT EYE AND THEN REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO A CRACK IN THE LENS. PROVISC WAS USED (ACCLIMATIZED FULLY TO THE OPERATING ROOM TEMPERATURE) AS A CARTRIDGE LUBRICANT. THE BACK-UP LENS WAS IMPLANTED SUCCESSFULLY (SAME MODEL AND DIOPTER). NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY. THE ISSUE WAS NOT DUE TO USE ERROR. THE PATIENT IS RECOVERING WELL. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001256 ↗
• MalfunctionApr 24, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SURGEON NOTICED A TEAR IN THE PRELOADED INTRAOCULAR LENS (IOL) BEFORE THE LENS WAS USED. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175898 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED THAT AN MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) GOT DAMAGED IN FIELD. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452281 ↗
• MalfunctionMar 29, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED DURING IMPLANTATION, THE BACK HAPTIC OF THE DIB00 INTRAOCULAR LENS (IOL) MALFUNCTIONED AND THE LENS WOULD NOT RELEASE FROM THE PRE-LOADED CARTRIDGE. THE CARTRIDGE TIP HAD PATIENT CONTACT. THERE WAS NO VITRECTOMY, NO MEDICAL ATTENTION REQUIRED, AND NO MEDICATION PRESCRIBED HOWEVER IT IS UNKNOWN IF THERE WAS INCISION ENLARGEMENT OR SUTURE(S). REPLACEMENT LENS INFORMATION IS UNKNOWN. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640864 ↗
• MalfunctionFeb 23, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOTICED TO BE DAMAGED AFTER IT WAS IMPLANTED IN THE LEFT EYE. THE IOL WAS REMOVED AND REPLACED WITHIN THE SAME PROCEDURE WITH A BACKUP OF THE SAME MODEL AND DIOPTER. THE SUSPECT IOL WAS DISCARDED AND THEREFORE WILL NOT BE RETURNED. THERE WAS NO INJURY REPORTED AND NO MEDICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. REPORTEDLY, POST-OPERATIVELY THE PATIENT IS DOING EXCELLENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433327 ↗
• MalfunctionJun 29, 2022Crack; Inaccurate Delivery; Crack; Inaccurate Delivery

  IT WAS REPORTED THAT AS THE SURGEON ADVANCED THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE WOUND MADE ON PATIENT'S OPERATIVE EYE, A CRACKING WAS HEARD, AND THE CARTRIDGE SPLIT APART. THE BACKUP LENS TOO STARTED TO DO THE SAME THING, ALTHOUGH NOT AS BADLY AS THE FIRST LENS. THE SURGERY WAS CONTINUED WITH THE BACKUP LENS. IT WAS INDICATED THAT BALANCED SALT SOLUTION (BSS) WAS USED TO LOAD THE LENS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE FIRST LENS WHICH WAS PARTIALLY INSERTED AND REMOVED, AND A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE BACKUP LENS WHICH WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849314 ↗
• MalfunctionJun 28, 2022Crack; Crack

  IT WAS REPORTED THAT AS THE SURGEON ADVANCED THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE WOUND OF THE PATIENT'S OPERATIVE EYE, A CRACKING WAS HEARD AND THE CARTRIDGE SPLIT APART. THE SURGERY WAS COMPLETED AND THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848620 ↗
• MalfunctionDec 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TRAILING HAPTIC GOT TORN OFF DURING INSERTION OF A PRELOADED MODEL INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE. IOL WAS FULLY INSERTED INTO PATIENT'S EYE. INCISION WAS ENLARGED TO REMOVE THE LENS AND NEW IOL OF SAME MODEL AND DIOPTER WAS IMPLANTED INTO PATIENT'S EYE. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS OTHER THAN INCISION ENLARGEMENT WERE DONE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12990489 ↗
• MalfunctionSep 10, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT WHEN THE SURGEON TRIED INSERTING A DIB00 MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE IT DID NOT INSERT PROPERLY. THE LENS HAD PATIENT CONTACT, BUT DID NOT INSERT COMPLETELY INTO THE EYE. WHILE THE SURGEON WAS INSERTING THE LENS, IT BENT TO ONE SIDE AND THE SURGEON HAD TO STOP AND HALF OF THE LENS WAS OUT OF THE CARTRIDGE. PROCEDURE WAS COMPLETELY SUCCESSFULLY USING BACKUP LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THERE WAS NO DAMAGE TO THE LENS AND THAT THE ISSUE WITH THE LENS WAS THAT THE LENS BENT TO ONE SIDE DURING INSERTION. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS WERE DONE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455059 ↗