TECNIS IOL DIU150 (REF DIU150U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474746510), received between May 14, 2022 and Feb 17, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING SEVERE BLURRY VISION WITH PRELOADED TORIC MONOFOCAL INTRAOCULAR LENSES (IOLS) IN BOTH EYES, AFFECTING BOTH DISTANCE AND NEAR VISION. THE PATIENT WAS UNABLE TO FUNCTION ADEQUATELY, AND AN IOL EXCHANGE WAS PLANNED. THESE ISSUES WERE IDENTIFIED DURING A POSTOPERATIVE EXAMINATION. NO PATIENT HARM WAS REPORTED. THE PATIENT HAD A HISTORY OF LASIK (LASER-ASSISTED INTRASTROMAL KERATOMILEUSIS) AND SIGNIFICANT SPHERICAL ABERRATIONS IN THE CORNEAS. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE LENSES IN BOTH EYES WERE EXPLANTED. THE REPLACEMENT LENSES FOR BOTH EYES ARE ANOTHER JOHNSON & JOHNSON, BUT DIFFERENT MODELS AND DIOPTERS: ZCU150 +18.5 D FOR THE RIGHT EYE AND ZCU150 +22.0 D FOR THE LEFT EYE. PREOPERATIVE REFRACTION FOR THE RIGHT EYE (OD) WAS -2.75 -0.75 × 152 WITH A BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) OF 20/15-2, WHILE POSTOPERATIVE REFRACTION WAS PLANO -0.75 × 152 WITH A BSCVA OF 20/20-1, DESCRIBED BY THE PATIENT AS BLURRY AND DOUBLE. FOR THE LEFT EYE (OS), PREOPERATIVE REFRACTION WAS -2.50 -0.25 × 052 WITH A BSCVA OF 20/15-1, WHILE POSTOPERATIVE REFRACTION WAS -1.50 -0.25 × 006 WITH A BSCVA OF 20/40-1. THE INTENDED TARG

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24370198 ↗
• InjuryJun 7, 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 THE PATIENT'S RIGHT EYE AS THE PATIENT COULD NOT ADAPT TO THE LENS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO PATIENT INJURY. PATIENT WAS UNABLE TO PERFORM ONE OR MORE DAILY ACTIVITIES POST-SURGERY. THERE WAS NO PRODUCT QUALITY ISSUE. THE DEVICE DID NOT WORK AS INTENDED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO CALCULATION ERROR. THERE WAS NO PATIENT INJURY. THE PATIENT STATES THEY WERE UNABLE TO DRIVE AT NIGHT, DUE TO THE TORIC LENS AND IT WAS RESOLVED SINCE THE LENS WAS EXCHANGE. THE LENS WAS REPLACED WITH DIB00 WITH 21.0 DIOPTER. THE PATIENT IS HAPPY WITH VISION, AND NO COMPLAINTS SINCE THE IENS WAS EXCHANGED. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22163839 ↗
• MalfunctionMar 10, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THEN REMOVED. THE DOCTOR NOTICED A SCRATCH ON THE LENS AFTER IT WAS IMPLANTED SO THE LENS WAS THEN CUT AND EXPLANTED. DOCTOR REPLACED THE LENS WITH THE SAME MODEL AND DIOPTER, SERIAL NUMBER (B)(6). REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT IMPACTED BY THIS EVENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAY IN PROCEDURE. MEDICATION OUTSIDE THE STANDARD OF CARE WAS NOT SOUGHT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18872270 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO REFRACTIVE ERROR. THE LENS WAS EXPLANTED AND REPLACED WITH LENS MODEL DIB00 17.5 DIOPTER IN A SECONDARY PROCEDURE. THERE WAS AN INCISION ENLARGEMENT. THERE WAS NO PATIENT INJURY. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. PATIENT¿S OUTCOME WAS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 18330586 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THE DIU150 MODEL INTRAOCULAR LENS (IOL) HAPTIC WAS BENT AND THERE WAS PATIENT CONTACT. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER DIU150 18.5 DIOPTER IOL DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. PATIENT OUTCOME POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574665 ↗
• MalfunctionAug 4, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THE PRELOADED JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S RIGHT EYE. A SCRATCH WAS NOTED THROUGH THE CENTER OF THE OPTIC. THE TEMPORAL INCISION WAS EXTENDED AND THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THEREFORE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP LENS. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17456744 ↗
• InjuryJul 13, 2023Unstable; Unstable

  IT IS REPORTED THAT AFTER 2 WEEKS OF INITIAL IMPLANT, DIU150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS EYE AS THE LENS COULD NOT BE CENTERED AND WAS EXCHANGED FOR AN AR40 IOL. ADDITIONAL INFORMATION RECEIVED THAT LENS WAS NOT BEING RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17317578 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOT HAPPY DUE TO EXPERIENCING BLURRY VISION AND REQUESTED FOR THE INTRAOCULAR LENS (IOL) TO BE EXPLANTED. THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AND A NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14692415 ↗
• MalfunctionMay 14, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT AND THE EVENT WAS OBSERVED DURING HANDLING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403422 ↗