TECNIS SIMPLICITY DIB00 (REF DIB00U0130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474731615), received between Dec 12, 2022 and Sep 18, 2026 — classified as 7 injuries, 10 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.

• MalfunctionSep 18, 2026Ejection Problem

  It was reported that the trailing haptic of the preloaded monofocal intraocular lens (IOL) was stuck in the cartridge. The physician successfully loosened the haptic and implanted the lens. No additional surgical maneuvers beyond the standard surgical technique were required to deliver or position the IOL. Provisc Ophthalmic Viscosurgical Device (OVD) was used to fill the cartridge prior to loading the lens according to the Directions for Use (DFU). No patient injury was reported. The current patient outcome was reported as standard. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820435 ↗
• MalfunctionJul 27, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024250 ↗
• MalfunctionMay 7, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DURING THE SAME PROCEDURE DUE TO THE END BULB OF THE LENS HAPTIC ADHERING TO THE OPTIC, AND A REPLACEMENT COMPETITOR LENS WAS SUCCESSFULLY INSERTED. THE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/30 PRE-OPERATIVELY TO 20/100 POST-OPERATIVELY, WITH WEEKLY IMPROVEMENT OBSERVED. AN ANTERIOR VITRECTOMY WAS REQUIRED PRIOR TO LENS IMPLANT AND WAS COMPLETED SUCCESSFULLY, WITH STANDARD SUTURES APPLIED. NO MEDICATION OUTSIDE OF STANDARD CARE WAS PRESCRIBED, AND NO FURTHER SURGICAL INTERVENTIONS ARE PLANNED. THERE WAS NO DELAY IN PROCEDURE. THE PATIENT IS CURRENTLY STABLE AND SHOWING IMPROVEMENT. THE PRODUCT IS UNAVAILABLE FOR INVESTIGATION. THE CUSTOMER HAS NO ADDITIONAL INFORMATION REGARDING THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119881 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS FULLY IMPLANTED IN THE PATIENT¿S LEFT EYE. DURING THE POSTOPERATIVE EXAMINATION, THE PATIENT WAS UNABLE TO ADAPT TO MONOVISION. THE LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A LENS OF THE SAME MODEL WITH A 1.5-DIOPTER POWER DIFFERENCE (DIB00, 11.5 D). NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PROCEDURAL DELAYS WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED. THE PATIENT FULLY RECOVERED. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 25034784 ↗
• MalfunctionApr 1, 2026Break; Failure to Advance; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) FAILED TO ADVANCE CORRECTLY, RESULTING IN LENS DAMAGE AND PLUNGER ROD ISSUE DESPITE NO CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761197 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED THEN EXPLANTED DURING A PROCEDURE. THE IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24731886 ↗
• InjuryDec 26, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, THE DIB00 MODEL INTRAOCULAR LENS (IOL) FELL INTO THE BACK OF THE PATIENT'S EYE, REQUIRING AN ANTERIOR VITRECTOMY. A LENS DEFECT WAS ALSO REPORTED. THE PROCEDURE WAS COMPLETED USING A NEW LENS; HOWEVER, IT WAS ALSO REPORTED THE IOL IS STILL IN THE PATIENT'S EYE. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 23900982 ↗
• MalfunctionFeb 24, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT DURING HANDLING/PRIOR TO INSERTION A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS MAJOR RESISTANCE WHILE INSERTING, SO THE SURGEON ABORTED AND SAW A SCRATCH ON THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454511 ↗
• MalfunctionJan 29, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS GETTING STUCK IN THE WOUND DURING IMPLANTATION. THE ISSUE WAS NOTICED DURING IMPLANTATION/APPLICATION. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269341 ↗
• MalfunctionJan 18, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS BENT. THE ISSUE WAS NOTICED AFTER THE IOL WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH AN IOL OF THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186392 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON CHANGED A MONOFOCAL INTRAOCULAR LENS (IOL) TO A NON-JOHNSON & JOHNSON LENS. THE REASON FOR THE EXCHANGE WAS NOT SPECIFIED. IT WAS INDICATED THAT THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 21098515 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A GAPING HOLE/DEFECT IN THE CENTER OF THE OPTIC. THE IOL WAS FULLY INSERTED, REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. IT WAS UNKNOWN IF DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. AND IT WAS UNKNOWN IF SUTURES AND AN INCISION ENLARGEMENT WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098373 ↗
• MalfunctionOct 17, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THERE WAS SCRATCH ON THE LENS. THERE WAS A SLIGHT INCISION ENLARGEMENT FOR REMOVING THE LENS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT SCRATCH IN THE LENS WAS NOTICED AT THE DAY OF SURGERY, AFTER THE LENS WAS IMPLANTED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH THE SAME MODEL AND SAME DIOPTER LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471885 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CAPSULE WAS BROKEN. A DIFFERENT LENS OF ANOTHER BRAND WAS USED. THERE IS NO PATIENT HARM. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 20184360 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS IS BEING RETURNED DUE TO TORN CAPSULE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18976451 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE AND THEN REMOVED. REPORTEDLY, THE PATIENT¿S CAPSULE TORE. THE HARM WAS NOT THE RESULT OF THE CONTACT WITH THE PRODUCT. THE DOCTOR PERFORMED AN ANTERIOR VITRECTOMY. A NON JOHNSON AND JOHNSON LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER INJURIES REPORTED AND NO INCISION ENLARGEMENT WAS REQUIRED. THE SUSPECT PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16665457 ↗
• MalfunctionDec 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IS BEING DEFECTIVE. THE LENS DID NOT UNFOLD WHEN IT WAS RELEASED FROM THE CARTRIDGE. IT WAS REPLACED WITH BACK-UP LENS SAME MODEL AND DIOPTER SIZE AS SUSPECT IOL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE. NO PATIENT POST-OP INJURY. IT WAS WASTED/ THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15962802 ↗