TECNIS IOL DIU150 (REF DIU150U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474746497), received between Sep 9, 2021 and Jul 2, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) REQUIRED EXPLANTATION FOLLOWING SURGERY DUE TO BLURRED VISION OBSERVED DURING POSTOPERATIVE EXAMINATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25698890 ↗
• InjuryApr 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS PUSHED OUT AFTER BEING INSERTED INTO THE LEFT EYE OF A PATIENT DUE TO HIGH PRESSURE IN THE PATIENT'S EYE. A BACKUP LENS WAS IMPLANTED AFTER THE EYE PRESSURE WAS REDUCED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES OR VITRECTOMY, AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED SIMBRINZA EYE DROPS (THREE TIMES DAILY) AND DIAMOX 500 MG (THREE TIMES DAILY). THE DIRECTIONS FOR USE WERE FOLLOWED. THE REPORTED ISSUE DID NOT IMPACT THE PATIENT¿S ACTIVITIES OF DAILY LIVING, AND THE PATIENT WAS CONFIRMED TO HAVE FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 24852966 ↗
• MalfunctionMay 10, 2025Contamination; Contamination

  WHEN LOADING THE DIU150 MODEL INTRAOCULAR LENS (IOL), THE SURGICAL TECHNICIAN NOTICED THERE WAS A "SPEC" IN THE SHAFT OF THE LENS CARTRIDGE, IN FRONT OF THE IOL. UNDER THE MICROSCOPE, THE DOCTOR DID NOT SEE THE "FLECK" OF DEBRIS IN THE LENS CARTRIDGE AND PROCEEDED TO IMPLANT THE IOL. AS HE INSERTED THE DELIVERY SYSTEM INTO THE CLEAR CORNEAL INCISION (CCI), AND STARTED TO TURN THE HANDLE CLOCKWISE, THE DOCTOR NOTICED THE "MATERIAL" SHOOT INTO THE ANTERIOR CHAMBER. HE STOPPED AS THE FIRST HAPTIC CAME THROUGH AND PULLED THE INJECTOR OUT OF THE EYE. THE SURGEON REMOVED THE MATERIAL WITH A MCPHERSON FORCEPS. THERE IS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. THE PROCEDURE COMPLETED SUCCESSFULLY USING A BACK-UP DIU150 17.5 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS DOING FINE, NO CONCERNS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999690 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE.. THE PATIENT EXPERIENCED A REFRACTIVE ERROR FOR APPROXIMATELY TWO MONTHS. THE IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL BUT SAME DIOPTER, MODEL DIU225, 17.5 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS AN INCISION ENLARGEMENT, SUTURES, VITRECTOMY OR DELAY IN PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21692849 ↗
• MalfunctionJun 21, 2024Scratched Material; Scratched Material

  IT IS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD BEEN SCRATCHED, AND THE LENS CAME OUT OF THE BOX SCRATCHED. THERE WAS NO PATIENT CONTACT. THE LENS WAS DISCARDED. ADDITIONAL INFORMATION WAS RECIEVED AND IT WAS LEARNT THAT LENS WAS REPLACED WITH ANOTHER J&J LENS WITH THE SAME DIOPTER AND MODEL IOL. THE PATIENT¿S OUTCOME IS UNKNOWN. REPORTEDLY THERE WAS NO ISSUE WITH THE BOX BEING DAMAGED AND NO BREACH OR POTENTIAL BREACH IN THE STERILITY OF THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589125 ↗
• InjuryMay 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO RESIDUAL REFRACTIVE ERROR. THE INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY SUCH AS A CAPSULE TEAR. THE REPLACEMENT LENS IS A DIFFERENT JNJ MODEL, DIB00 17.0 DIOPTER. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 19295974 ↗
• MalfunctionSep 9, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON NOTICED SCRATCH ON THE OUTER PORTION OF THE PRELOADED INTRAOCULAR LENS (IOL) AFTER IMPLANTATION INTO PATIENT'S OPERATIVE EYE. THE DOCTOR DECIDED TO KEEP THE LENS IMPLANTED AS THE SCRATCH WAS NOT IN PATIENT'S SIGHT. NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12449066 ↗