TECNIS IOL DIU150 (REF DIU150U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474746534), received between Aug 24, 2021 and Aug 7, 2026 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Break; Failure to Fold

  It was reported that during handling prior to insertion, the doctor observed that the leading haptic of a single piece preloaded Toric intraocular lens (IOL) was inverted and the did not look right. There was no patient contact. The product was discarded, and a backup IOL of the same model was successfully used to complete the procedure. Direction for use was followed. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184249 ↗
• MalfunctionDec 18, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT WHEN INSERTING THE PRELOADED TORIC MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S RIGHT EYE, BOTH THE SURGEON AND SCRUB TECHNICIAN OBSERVED THAT THE LENS WAS COMING OUT OF THE LOADER BACKWARDS. THE LENS WAS IMMEDIATELY REMOVED AND ANOTHER LENS WAS INSERTED. THERE WAS PATIENT CONTACT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE LENS WAS FULLY DELIVERED AND THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. IT IS UNKNOWN IF ANY UNPLANNED SURGICAL INTERVENTION OR ADDITIONAL SURGICAL MANEUVERS OUTSIDE THE NORMAL STANDARD OF PRACTICE WERE REQUIRED OR IF THERE ARE ANY PLANNED SURGICAL INTERVENTIONS. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838658 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED LENS HAD CRACKED AND SLIGHTLY MELTED DURING IMPLANTATION. THE LENS WAS FULLY INSERTED, REMOVED AND REPLACED WITH AN UNKNOWN IOL DURING THE SAME PROCEDURE. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381356 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD MISSHAPED. THERE IS NO INFORMATION AVAILABLE FOR REPLACEMENT LENS. THERE WAS NO PATIENT CONTACT. THE LENS HAS BEEN DESTROYED AND DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18126480 ↗
• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED THAT THERE WAS A DEFECT ON THE PRELOADED INTRAOCULAR LENS (IOL). THE ISSUE WAS NOT DUE TO USE ERROR. BALANCED SALT SOLUTION (BSS) WAS USED WITH NO ADDITIVES AT ROOM TEMPERATURE. THERE WERE NO DELAYS IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS. THE LENS WAS FULLY INSERTED AND THEN CUT OUT OF THE RIGHT EYE AND AN UNPLANNED INCISION ENLARGEMENT WAS REQUIRED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17769362 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT DOCTOR HAD EXPLANTED INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 17263353 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED THAT THE DEFECTIVE INTRAOCULAR LENS (IOL) WAS WASTED. IT IS UNKNOWN IF THE PRODUCT HAD PATIENT CONTACT. IT WAS INDICATED THAT THE DEVICE IS NOT BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892448 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING REFRACTIVE SURPRISE WITH ASTIGMATISM AND A HISTORY OF LASIK. THE INCISION WAS ENLARGED, AND ONE SUTURE WAS PLACED. THERE WAS NO CAPSULE TEAR REPORTED AND NO VITRECTOMY. CUSTOMER PLANS ON RETURNING THE EXPLANTED IOL. THE REPLACEMENT LENS IS A DIFFERENT MODEL BUT SAME DIOPTER, DIB00 19.5 DIOPTER. REPORTEDLY, THE CUSTOMER DOES NOT HAVE INFORMATION ON THE PATIENT¿S POST-OPERATIVE CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16500317 ↗
• MalfunctionFeb 28, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE FULLY INSERTED INTRAOCULAR LENS (IOL) HAD A LARGE SCRATCH ON THE POSTERIOR SIDE OF THE OPTIC. THE LENS REMAINS IMPLANTED. THE SURGEON IS NOT SURE YET IF IT WILL REQUIRE AN EXCHANGE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT IT IS DIFFICULT TO TELL IF THERE IS ANY IMPACT TO THE PATIENT'S VISION DUE TO THIS ISSUE BECAUSE THE PATIENT HAS MACULAR DEGENERATION, SO ALTHOUGH THE VISION DOES NOT CORRECT TO 20/20, IT COULD BE DUE TO THE MACULA. THERE WAS NO PATIENT INJURY. THERE IS NO INDICATION OF ANY MEDICAL OR SURGICAL INTERVENTIONS. THERE IS THE POSSIBILITY OF AN IOL EXCHANGE, BUT THAT WILL NOT BE DONE AS OF NOW. PATIENT OUTCOME IS 20/30 VISUAL ACUITY. THERE ARE NO PLANNED INTERVENTIONS AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457555 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE RIGHT EYE, A REFRACTIVE ERROR (MYOPIC, RESIDUAL ASTIGMATISM) WAS IDENTIFIED AT POST-OPERATIVE VISITS. PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/30 CORRECTED (CC). POST-OPERATIVE VA WAS 20/40 UNCORRECTED (SC) AND 20/20- CC. THE PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THE IOL WAS EXPLANTED FROM THE EYE. THERE WAS NO REQUIRED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THERE WAS NO DELAY IN PROCEDURE. THE END USER DID NOT SEEK MEDICAL ATTENTION AND IT IS UNKNOWN IF MEDICATION WAS PRESCRIBED. THROUGH FOLLOW-UP IT WAS LEARNED THAT SYMPTOMS STARTED ON (B)(6)2022. THE PATIENT HAD A 16-CUT RADIAL KERATOTOMY (RK) PROCEDURE DONE YEARS AGO. THE PATIENT'S PRE-OPERATIVE VA WAS 20/30- UNCORRECTED. THE PATIENT WAS APPROXIMATELY 1.0 D MYOPIC WITH RESIDUAL ASTIGMATISM. THE DOCTOR NOTED THAT THE CUTS FROM THE RK MAKE IT DIFFICULT TO CHOOSE A LENS. THIS PATIENT HAS BEEN CONSISTENTLY NEAR SIGHTED, SO THE DOCTOR CHOSE A WEAKER POWER AND TORIC LENS TO ADDRESS THE ASTIGMATISM. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL DIU, DIFFERENT CYLINDER OF 3.00 AND DIFFERENT DI

  Patient problems: Visual Impairment

  MAUDE report 15684972 ↗
• MalfunctionJul 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) LOOKED TORN AS THE CARTRIDGE TOUCHED THE PATIENT'S LEFT EYE, THEREFORE, THE SURGEON STOPPED. THERE WAS NO PATIENT INJURY AND ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042679 ↗
• MalfunctionJun 16, 2022Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRELOADED DEVICE HAD FAULTY PLUNGER AND THE TRAILING HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS KINKED. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON & JOHNSON DIB00 LENS. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14723028 ↗
• MalfunctionMay 25, 2022Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SEAL WAS BROKEN WHEN AN INTRAOCULAR LENS (IOL) ARRIVED. THE CUSTOMER DID NOT TRUST THE STERILITY SINCE THE INNER WRAP IS A SINGLE WRAP. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493793 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SEAL WAS BROKEN WHEN IT ARRIVED. THE CUSTOMER DID NOT TRUST THE STERILITY SINCE THE INNER WRAP IS A SINGLE WRAP. THERE WAS NO REPORTED PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491779 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS EYHANCE INTRAOCULAR LENS (IOL) EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO MECHANICAL COMPLICATIONS. THE PATIENT DID NOT SEE AS CLEARLY AS THEY WOULD LIKE TO. THE REPLACEMENT LENS IS THE SAME MODEL BUT A HIGHER DIOPTER (22.0). THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. REPORTEDLY THE PATIENT IS DOING GOOD POST EXCHANGE. THE LENS WAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 13462562 ↗
• InjurySep 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  RECEIVED REPORT INDICATING THAT THE INTRAOCULAR LENS (IOL) MODEL DIU150 WAS EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO MECHANICAL COMPLICATIONS. THE EXPLANTED IOL WAS REPLACED WITH MODEL ZCU150 DIOPTER 19.0. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED. AT THE TIME OF THIS REPORT IT WAS STATED THAT THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510856 ↗
• MalfunctionAug 24, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD BENT OR BROKEN HAPTIC. THE LENS WAS INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND THE PATIENT HAD RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362566 ↗