TECNIS SIMPLICITY DIB00 (REF DIB00U0160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474731677), received between Nov 16, 2021 and Jan 13, 2026 — classified as 5 injuries, 12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Crack

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS CRACKED AT THE TIP. THE ISSUE WAS NOTICED AFTER THE IOL WAS INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059574 ↗
• MalfunctionDec 19, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE LENS CARTRIDGE CONTACTED THE PATIENT¿S LEFT EYE AND THE LENS WAS INJECTED PREMATURELY, RESULTING IN INCOMPLETE INSERTION. NO EXTRA SURGICAL TECHNIQUE OR MANEUVERS OUTSIDE YOUR NORMAL STANDARD OF PRACTICE REQUIRED TO DELIVER AND/OR POSITION THE LENS. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS REQUESTED. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, PROCEDURAL DELAY, OR ADDITIONAL MEDICATION WERE REQUIRED. PATIENT FULLY RECOVERED WITH NO IMPACT ON DAILY ACTIVITIES. DIRECTIONS FOR USE WERE FOLLOWED. THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857930 ↗
• MalfunctionNov 19, 2025Break; Break

  A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS REPORTED AS DEFECTIVE; NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER (DIB00, 16.0 D). NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED ¿ SPECIFICALLY, NO CAPSULAR TEAR, UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR NEED FOR SUTURES. NO MEDICATIONS BEYOND THE STANDARD OF CARE WERE REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THE REPORTED DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596886 ↗
• MalfunctionAug 25, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE IOL WAS NOTICED TO BE SCRATCHED AFTER IT WAS INSERTED INTO THE EYE. A BACKUP LENS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891420 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE IT WAS NOTICED BY THE SURGEON THAT THE LENS WAS BROKEN INTO PIECES. THE ISSUE WAS OBSERVED DURING IMPLANTATION/APPLICATION OF THE LENS. THE LENS PIECES WERE REMOVED AND REPLACED WITH ANOTHER LENS WITH OUT ANY DIFFICULTY. THE BEST CORRECTED VISUAL ACUITY PRE-OP WAS 20/70-1 AND THE BEST CORRECTED VISUAL ACUITY POST-OP WAS 20/40-1. THERE WAS DELAY IN PROCEDURE BY FIVE MINUTES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073530 ↗
• InjuryMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A REPORT INDICATED THAT THE PRELOADED INTRAOCULAR LENS (IOL) EXHIBITED A CUT, WHICH WAS IDENTIFIED AFTER ITS INSERTION. THE PRELOADED DIB00 MODEL IOL WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE (OCULAR DEXTER) WHEN THE CUT ON THE LENS WAS DISCOVERED. DURING THE SAME PROCEDURE, THE IOL WAS REMOVED AND REPLACED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. THERE WERE NO INJURIES SUSTAINED BY THE PATIENT; HOWEVER, TWO SUTURES WERE REQUIRED DURING THE PROCEDURE. POST-OPERATIVE STATUS OF THE PATIENT WAS REPORTED AS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702755 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF POSITIVE DYSPHOTOPSIA, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. REPLACEMENT IOL INFORMATION IS UNKNOWN. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. BEST CORRECTED DISTANT VISUAL ACUITY (BCDVA): -0.50+0.50X076 20/25. PATIENT STATUS POST LENS EXCHANGE PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers

  MAUDE report 19564135 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THAT THE DOCTOR REALIZED THE INTRAOCULAR LENS (IOL) WAS TWISTED, WHEN THE LENS WAS ADVANCED, IT "TWISTED" WITHIN THE SYRINGE BEFORE INSERTION WITH THE LOADER. IT WAS STATED THAT THE LENS WAS NOT ABLE TO BE DISCHARGED, UNABLE TO ASSESS IF IT WAS DAMAGED. THE ISSUE WAS NOTICED DURING HANDLING/PRIOR TO INSERTION OF THE LENS. THERE WAS NO PATIENT CONTACT. IT WAS INDICATED THAT THE ISSUE WAS NOT DUE TO USE ERROR. THE PROCEDURE WAS COMPLETED WITH A BACKUP/REPLACEMENT IOL (THE BACK UP LENS INFORMATION IS NOT AVAILABLE). THE PATIENT OUTCOME WAS REPORTED AS EXPECTED. THE LUBRICATION USED WAS INTRODUCED FROM CARTRIDGE CANOPY. NO BLANCED SALT SOLUTION (BSS) WAS USED. THE INITIAL ADVANCEMENT WAS REPORTED AS A GENTLY ADVANCE PLUNGER. THE INITIAL MOVEMENT OF THE LENS IS DONE BY THE SCRUB TECH IF THEY ARE TRAINED, OTHERWISE THE SURGEON. SURGEON DOES THE FIRST TWIST AND COMPLETES THE REST OF THE ADVANCEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194055 ↗
• MalfunctionDec 4, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD THE TRAILING HAPTIC STUCK IN THE INSERTER AND WOULD NOT RELEASE FULLY INTO THE EYE. THE SURGEON HAD TO USE ANOTHER INSTRUMENT TO GET THE TRAILING HAPTIC OUT TO FINISH THE PROCEDURE. DURING CATARACT SURGERY THE SURGEON INDICATED HE MAKES A 2.2MM INCISION SIZE. IT WAS ALSO REPORTED THAT THE SURGEON USED EITHER VISCOELASTIC OR BSS (BALANCED SALT SOLUTION) TO LUBRICATE THE LENS. SURGEON ALSO INDICATED HE ADVANCED THE LENS COMPLETELY AS THE DIAL WAS FLUSH TO THE BODY OF THE INSERTER. THE LENS REMAINS IMPLANTED. THE PATIENT IS FINE AND THE OUTCOME IS AMAZING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263467 ↗
• MalfunctionJun 22, 2023Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE FOR THE PRELOADED JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) CRACKED AT THE TIP. THE ISSUE WAS NOTICED DURING IMPLANTATION. THE IOL DID NOT CONTACT THE EYE ONLY THE CARTRIDGE TIP. REPORTEDLY, THERE WAS NO CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187709 ↗
• MalfunctionMar 16, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED IN THE RIGHT EYE, IT WAS NOTICED THAT THE LENS HAD SEVERAL INDENTATIONS AND IRREGULARITIES WITHIN THE VISUAL AXIS, AND THEREFORE THIS LENS WAS REMOVED USING THE MICRO SURGICAL TECHNOLOGY (MST) INSTRUMENT SET AND ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL, DIFFERENT DIOPTER OF 16.5) WAS PLACED INTO THE CAPSULAR BAG. THE REPLACEMENT LENS WAS INSPECTED AND FOUND TO BE FREE OF ANY OPTICAL IRREGULARITIES. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTIONS WERE INDICATED. PATIENT STATUS IS UNKNOWN. IT WAS NOTED THAT THE LENS WAS NOT STUCK IN THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554323 ↗
• MalfunctionJan 26, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) UPON INSERTION INTO THE PATIENT'S LEFT EYE, THE IOL EJECTED PREMATURELY. A NEW LENS WAS OPENED AND INSERTED WITH NO PROBLEMS. THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250895 ↗
• MalfunctionJan 5, 2023Break; Break

  A SURGEON REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BAD. IT IS UNKNOWN IF THERE WAS A PATIENT CONTACT WITH THE DEVICE. A DCB00 MODEL LENS WAS USED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108442 ↗
• InjuryDec 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS COMPLAINTS OF DIFFICULTY SEEING TO READ STREET SIGNS AND NIGHT DRIVING. POST-OPERATIVELY, OS VISION IS ONLY CORRECTING TO 20/30-2 AS OF (B)(6) 2022 . AN IOL EXPLANT WAS PLANNED FOR A LATER DATE WITH ANOTHER DIB00, DIOPTER UNKNOWN, AS THE REPLACEMENT LENS. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LENS WAS EXPLANTED ON (B)(6) 2022 . THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15912408 ↗
• 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 DUE TO UNABLE TO ADAPT TO VISION/VISUAL DISTURBANCE NOTED. A NON-JOHNSON & JOHNSON LENS WAS USED AS THE REPLACEMENT. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15497620 ↗
• MalfunctionJul 1, 2022Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS PREPPED BY THE TECHNICIAN WITH NO ISSUES. THE LENS WAS INSERTED, IN THE RIGHT EYE, BY THE SURGEON WHEN A SCRATCH DOWN THE MIDDLE OF THE LENS WAS NOTICED. THE IOL WAS CUT INTO PIECES AND REMOVED. ANOTHER IOL OF THE SAME MODEL AND DIOPTER WAS INSERTED WITH NO ISSUES. THERE WAS NO REPORTED ISSUE WITH THE LENS STICKING OR ADVANCING DURING IMPLANTATION; HOWEVER, THE SURGEON SAID THERE WAS A LITTLE RESISTANCE DURING INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14891296 ↗
• InjuryNov 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 FULLY INSERTED AND REMOVED FROM THE PATIENT'S LEFT EYE DUE TO CAPSULE TEAR. VITRECTOMY WAS DONE. THERE WAS NO ISSUE WITH THE LENS. THERE WAS NO PATIENT INJURY REPORTED. ACCOUNT PROVIDED THAT NO BACKUP LENS WAS INSERTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12824810 ↗