TECNIS SIMPLICITY DIB00 (REF DIB00U0170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05050474731691), received between Sep 21, 2021 and Jul 10, 2026 — classified as 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788654 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE FOLLOWING CATARACT SURGERY WITH A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, WHICH LED TO AN IOL EXCHANGE PROCEDURE. THE ORIGINAL IOL WAS REPLACED WITH AN IOL OF THE SAME MODEL WITH A 23.0 DIOPTER. THE EXPLANTED IOL WAS NOT TORN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25523307 ↗
• MalfunctionFeb 26, 2026Scratched Material; Ejection Problem

  IT WAS REPORTED THAT DURING A ROUTINE PROCEDURE, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. DURING DELIVERY, THE SECOND HALF OF THE OPTIC AND THE TRAILING HAPTIC BECAME CAUGHT IN THE INCISION. A SECONDARY INSTRUMENT WAS USED TO ADVANCE THE LENS THROUGH THE WOUND AND INTO THE CAPSULAR BAG. AFTER IMPLANTATION, A CONTINUOUS SCRATCH WAS OBSERVED ALONG THE OPTIC EDGE. THE PATIENT HAD NO PRE-EXISTING OCULAR CONDITIONS. THE SURGEON CHOSE NOT TO EXPLANT THE LENS, AS THE PATIENT IS SATISFIED WITH THE OUTCOME, HAS 20/20 VISION, AND THE INCLUSION-LIKE SPOTS ARE LOCATED OUTSIDE THE VISUAL AXIS. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT, AND NO FURTHER ACTION IS PLANNED AT THIS TIME. THE COMPLAINT DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465108 ↗
• InjuryApr 2, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED LENS WAS FULLY INSERTED AND THEN REMOVED IN THE SAME PROCEDURE DUE TO A CRACKED LENS. THE PROCEDURE WAS COMPLETED USING UNKNOWN BACKUP LENS. SUTURES ARE REQUIRED. THE PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756390 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS A BAD LENS WHICH WAS CRACKED AT THE HAPTIC JUNCTION. THE LARGE CRACK WAS NOTICED UPON IMPLANTATION. THE IOL WAS CUT WITH LENS CUTTERS AND REMOVED AND REPLACED. THE REPLACEMENT LENS WAS THE SAME MODEL AND DIOPTER AND WAS SUCCESSFULLY IMPLANTED IN THE CAPSULAR BAG. REPORTEDLY, THE REPLACEMENT LENS WAS INTACT WITHOUT ANY VISIBLE DEFECT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694452 ↗
• InjuryMar 14, 2025Adverse 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 EXPLANTED FROM PATIENT'S EYE. THE ISSUE WAS NOTICED AFTER IMPLANTATION/APPLICATION OF THE LENS. THE LENS WAS REMOVED IN THE SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO PATENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21612207 ↗
• MalfunctionJan 21, 2025Break; Contamination; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Scratched Material; Break; Contamination; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Scratched Material

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS HAD AN ISSUE NOTICED ON THE IOL AFTER IMPLANTATION. THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE WITH ANOTHER IDENTICAL MODEL OF THE JOHNSON & JOHNSON (J&J) INTRAOCULAR LENS (IOL). THE PATIENT FULLY RECOVERED AND THERE WERE NO UNPLANNED INCISIONS, SUTURES, OR VITRECTOMY INVOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21203555 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT THE LENS WAS DEFECTIVE. THE PATIENT'S CONTACT INFORMATION IS UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170711 ↗
• MalfunctionJan 10, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE TIP OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS BENT AND THE LENS WOULD NOT ADVANCE CORRECTLY. THERE WAS PATIENT CONTACT BUT THERE WAS NO ISSUES OR INJURY TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126934 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. THE SHIPPING BOX AND THE PRODUCT BOX WERE BOTH FINE. HOWEVER, THE LENS IN THE PRODUCT BOX WAS DAMAGED. THE ISSUE WAS NOTICED UPON OPENING THE BOX. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859309 ↗
• MalfunctionOct 10, 2024Break; Break

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO BE FAULTY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20424824 ↗
• MalfunctionOct 10, 2024Break; Break

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO BE FAULTY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20424275 ↗
• MalfunctionSep 16, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH. THE DOCTOR NOTICED THE SCRATCH AFTER THE IOL WAS IMPLANTED. SINCE THE SCRATCH IS IN THE PERIPHERY OF THE IOL THE DOCTOR DECIDED TO LEAVE IT. THE DOCTOR FEELS IT WILL NOT AFFECT THE PATIENT¿S VISION. THE IOL REMAINS IMPLANTED IN THE PATIENT¿S LEFT EYE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232491 ↗
• MalfunctionSep 11, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT A "BROKEN INTRAOCULAR LENS (IOL) WAS NOT COMING OUT" OF THE SIMPLICITY PRELOADED DIB00. IT WAS NOTED THAT THERE WAS PATIENT CONTACT. IT WAS LEARNED THAT THE CARTRIDGE WAS THROUGH CORNEAL INCISION INTO ANTERIOR CHAMBER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES DONE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING THE BACK-UP LENS. IT WAS A ROUTINE POSTOP COURSE, NO COMPLICATIONS, NO COMPLICATIONS. PROVISC WAS USED AS CARTRIDGE LUBRICATION WHICH WAS INTRODUCED INTO THE CARTRIDGE FROM THE CARTRIDGE CANOPY, WITH AN AVERAGE DWELL TIME OF 1 MINUTE. THE INITIAL ADVANCEMENT WAS DONE BY QUICKLY ADVANCING THE PLUNGER. THE SCRUB TECH DID THE INITIAL MOVEMENT AND FIRST TWIST. IT WAS UNINTERRUPTED ONCE PAST DWELL POSITION. WHEN ADVANCING THE LENS QUARTER TURNS WERE DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191654 ↗
• MalfunctionAug 28, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT UPON INSERTION INTO THE PATIENT'S LEFT EYE, THE PRELOADED INTRAOCULAR LENS (IOL) LEAD HAPTIC FRACTURED THE LENS, WHICH WAS REMOVED FROM THE EYE AND A SECOND IOL WAS USED (SAME MODEL AND DIOPTER). THE LENS WAS NOT STUCK IN THE CARTRIDGE. THERE WAS NO PATIENT INJURY. THERE WAS NO INDICATION OF MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING WELL POST-OPERATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086851 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNSPECIFIED REASONS. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP BUT THE CUSTOMER EXPLAINED THAT UNLESS THE PATIENT IS WITH ME, THEY ARE NOT ALLOWED TO PROVIDE ANY INFORMATION REGARDING THE PATIENT AND CASE. THEY¿RE ALSO NOT ALLOWED TO PROVIDE THE DOCTOR¿S EMAIL OR DIRECT TELEPHONE NUMBER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19736430 ↗
• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A TEAR IN THE LEADING HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694831 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DIB00 INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE. DURING POST OP EXAMINATION, PATIENT HAD ITCHING AND DIOPTER WAS ADJUSTED +1.50 AFTER WEARING CONTACT LENS POSTOPERATIVELY FOR 10 DAYS AND PATIENT REPORTED CLEARER VISION. DIB00 LENS WAS EXPLANTED DURING SECONDARY SURGERY. ADDITIONAL INFORMATION REVEALED THAT ALCON BSS WAS USED AS CARTRIDGE LUBRICATION. NO ADDITIVES USED. THERE WAS NO USE ERROR. THE REASON FOR EXPLANTING DIB00 LENS WAS STATED AS THE PATIENT WAS UNHAPPY WITH VISION. TRIED A CONTACT LENS WITH DIFFERENT DIOPTER AND PATIENT LIKED IT BETTER. IT WAS STATED THAT PATIENT COMPLAINED OF LESS THAN PERFECT VISION AND EXPERIENCED CLEARER VISION FROM A CONTACT LENS SO THE LENS WAS EXPLANTED AND NEW LENS IMPLANTED. THERE WAS NO INJURY AND NO ADDITIONAL MEDICAL/ SURGICAL INTERVENTION WERE REQUIRED. THE DIB00 LENS IS NOT BEING RETURNED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Red Eye(s)

  MAUDE report 17241516 ↗
• MalfunctionApr 27, 2023Break; Break

  IT WAS REPORTED THE PRE-LOADED DIB00 INTRAOCULAR LENS (IOL) WAS DEFECTIVE. PATIENT WAS UNABLE TO BE STILL, THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827403 ↗
• MalfunctionMar 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ARM OF THE PRELOADED INTRAOCULAR LENS (IOL) BROKE OFF DURING INSERTION INTO THE LEFT EYE. ONLY THE CARTRIDGE TIP HAD PATIENT CONTACT. NO INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY WAS REQUIRED. THERE WAS NO SERIOUS INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632905 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT'S VISION IS "GENERALLY OUT OF FOCUS." THE PATIENT DESCRIBES THE VISION AS BLURRED, CENTRALLY OUT OF FOCUS, AND HAVING GLARE AND DIFFUSED LIGHT. THE PATIENT ALSO CANNOT READ THE DASHBOARD IN THE CAR AND EXPERIENCES "BLINDING" GLARE AT NIGHT, HOWEVER DURING THE DAY IS NOT AS BAD. THE PATIENT FEELS THE VISION IS COMPLETELY "OFF". THE ISSUE WAS NOTICED IMMEDIATELY AND DISCUSSED IT WITH THE DOCTOR AT THE FIRST POST-OPERATIVE VISIT AND ALSO A FEW WEEKS LATER. THE DOCTOR TOLD THE PATIENT THAT THE EYE LOOKS FINE AND THE SURGERY WENT FINE AND WAS UNABLE TO TELL WHAT THE ISSUE WAS. DURING THE SECOND POST-OPERATIVE VISIT, THE DOCTOR ADVISED THAT THERE COULD POSSIBLY BE NEUROPATHY IN THE EYE AND REFERRED THE PATIENT TO A SECOND DOCTOR, WHO CONFIRMED THERE IS NO NEUROPATHY, AND THE THE EYE LOOKS FINE WITH NO ISSUES. THE PATIENT WAS THEN REFERRED TO A RETINAL SPECIALIST, WHO ALSO WAS UNABLE TO FIND ANY ISSUES AND CONFIRMED THERE WERE NO PRESSURE ISSUES. THE PATIENT SAW ANOTHER DOCTOR WHO, AFTER SIX MONTHS OF WAITING FOR IMPROVEMENT, SCHEDULED AN IOL EXCHANGE ON (B)(6) 2023. THROUGH FOLLOW-UP, IT WAS

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16595277 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO THE PATIENT UNABLE TO ADAPT TO VISION/VISUAL DISTURBANCE NOTED. IT WAS REPLACED WITH SOFPORT LENS. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 15499416 ↗
• MalfunctionSep 7, 2022Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS (IOL) HAD DISTORTED HAPTIC AND THE TRAILING HAPTIC WAS NOT TUCKED AND STICKING OUT WHICH COULD NOT BE ADJUSTED. THE HAPTIC WAS FACING THE WRONG WAY WHICH COULD NOT BE TURNED/ROTATED WITHOUT SCRATCHING/DAMAGING THE LENS. THE ACCOUNT BELIEVED IT WAS BECAUSE THE HAPTIC WAS DAMAGED. THERE WAS NO OTHER ISSUE WITH THE LENS AND THE PROCEDURE WAS COMPLETED USING ANOTHER LENS. THERE WAS NO PATIENT CONTACT WITH THE ORIGINAL LENS. THERE WAS NO USER ERROR INVOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375695 ↗
• MalfunctionJul 7, 2022Mechanical Jam; Scratched Material; Mechanical Jam; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS SCRATCHED AND WAS STUCK IN CARTRIDGE. 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 14951147 ↗
• MalfunctionJun 25, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A SMALL CRACK ON THE EDGE OF THE INTRAOCULAR LENS (IOL). IOL IS IMPLANTED AND SURGEON JUST WANTED TO GIVE US A HEAD UP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14819228 ↗