TECNIS IOL DIU150 (REF DIU150U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474746572), received between May 27, 2021 and May 15, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break; Ejection Problem

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIU150, THE TRAILING HAPTIC BECAME STUCK IN THE INJECTOR. THE PHYSICIAN WAS ABLE TO RELEASE THE HAPTIC USING A SECONDARY INSTRUMENT AND SUCCESSFULLY IMPLANT THE LENS; HOWEVER, THE HAPTIC APPEARED SLIGHTLY DEFORMED/STRAIGHTENED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194257 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT HAD AN UNACCEPTABLE MYOPIC REFRACTIVE SURPRISE, TARGET WAS -0.25 BUT THE PATIENT ENDED UP -1.25 D. BEST CORRECTED VISUAL ACUITY (BSVA) PRE-OPERATIVE WAS 20/30-2 AND POST-OPERATIVE WAS 20/20-2. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT ALSO REPORTED EXTREME DIFFICULTY PLAYING GOLF, AN IMPORTANT ACTIVITY OF DAILY LIVING (ADL), DUE TO THE INABILITY TO WEAR GLASSES WHILE PLAYING AS IT INTERFERES WITH HIS GAME. THE PATIENT WAS TEMPORARILY IMPAIRED AS A RESULT. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIU150 20.5 IOL. THERE WERE NO COMPLICATIONS, NO INCISION ENLARGEMENT, AND NO SERIOUS PATIENT INJURY DURING THE IOL EXPLANT PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 24178290 ↗
• MalfunctionDec 30, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS SHRIVELED AND HARDENED WHILE ADVANCING (WAS NOT SMOOTH). THE DOCTOR REQUESTED A NEW IOL. THERE WAS NO PATIENT CONTACT. NO FORCE WAS APPLIED DURING THE DELIVERY OF THE LENS. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE OPTIC, HAPTIC, OR CARTRIDGE TIP. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT IOL OF THE SAME MODEL AND DIOPTER. IT WAS REPORTED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926199 ↗
• MalfunctionNov 20, 2025Break; Wrong Label; Break; Wrong Label

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. THE PATIENT EXPERIENCED A REFRACTIVE OUTCOME OF -7 WHEN TARGETING PLANO. ADDITIONAL BIOMETRY CONFIRMED THE CORRECT LENS WAS SELECTED, BUT THE RESULTS WERE INCONSISTENT. IT WAS SUGGESTED THAT THE LENS MAY HAVE BEEN MISLABELED OR DEFECTIVE. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. THE DETAILS REGARDING AN UNPLANNED INCISION ENLARGEMENT, UNPLANNED SUTURES, UNPLANNED VITRECTOMY, OR PROCEDURAL DELAYS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23612917 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS BENT INSIDE THE INSERTER. THE ISSUE WAS NOTICED PRIOR TO INSERTION INTO THE EYE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612827 ↗
• MalfunctionDec 3, 2024Material Fragmentation; Material Fragmentation

  FOLLOWING INSERTION OF THE PRE-LOADED DIU150 MODEL INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC WAS COMPLETELY SEVERED. THE IOL WAS REMOVED FROM THE PATIENT'S EYE AND A LARGER INCISION WAS NECESSARY DURING THE PROCEDURE. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED USING ANOTHER IOL. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 20829091 ↗
• InjuryNov 14, 2024Adverse 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 PATIENT'S RIGHT EYE DUE TO REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED AND REPLACED WITH THE SAME MODEL LENS WITH 4.50 DIOPTER IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20686224 ↗
• MalfunctionOct 24, 2024Scratched Material; Scratched Material

  THE PRE-LOADED DIU150 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN SCRATCHED UPON INSERTION AND THERE WAS PATIENT CONTACT WITH THE IOL. THERE WAS NO PATIENT HARM, NO INCISION ENLARGEMENT, AND NO VITRECTOMY. A SIMILAR IOL WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519539 ↗
• InjuryOct 19, 2023Adverse 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 RIGHT EYE DUE TO THE PATIENT'S COMPLAINT OF "SEEING SHADOWS". ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DCB00, SAME DIOPTER). ONE 10-0 NYLON SUTURE WAS USED TO CLOSE THE WOUND DUE TO INCISION ENLARGEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT TOLERATED THE PROCEDURE WELL AND IS HAPPY WITH THE LEVEL OF VISION. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17971147 ↗
• InjuryJul 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE MECHANICAL COMPLICATIONS OF THE IOL. ANOTHER JOHNSON AND JOHNSON LENS OF MODEL DIU225, 21.0 DIOPTER WAS USED AS A REPLACEMENT LENS. THERE WAS AN INCISION ENLARGEMENT, BUT NO OTHER INTERVENTIONS REPORTED. THERE WAS NO PATIENT INJURY. THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17417999 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NEEDED DIFFERENT DIOPTER INTRAOCULAR LENS (IOL) HENCE LENS WAS EXPLANTED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. PATIENT DOING WELL POST-OP AND NO INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15979747 ↗
• MalfunctionOct 14, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE SURGEON WAS INJECTING AN INTRAOCULAR LENS (IOL) IT SOMEHOW TWISTED WHEN COMING OUT OF THE INJECTOR AND DID NOT SIT CORRECTLY ONCE COMPLETELY IN THE EYE. THE SURGEON DID NOT LIKE THE WAY THE LENS WAS, SO HE REMOVED IT AND PLACED ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) AS A REPLACEMENT. NO OTHER MEDICAL INTERVENTIONS WERE DONE. PATIENT IS DOING GOOD POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611869 ↗
• InjuryJan 19, 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 FROM THE RIGHT EYE DUE TO BLURRY VISION. THE BLURRY VISION WAS SECONDARY TO CORNEAL SCAR AND THE PATIENT HAD A SMALL AMOUNT OF MYOPIA. THE PATIENT'S PRE-OPERATIVE CORRECTED VISUAL ACUITY WAS 20/40 + 3. THE PATIENT'S POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS 20/25. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO DELAY IN THE PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (ZCB00 DIFFERENT MODEL AND DIFFERENT DIOPTER OF +20.5) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Corneal Clouding/Hazing; Visual Disturbances; Visual Impairment

  MAUDE report 13289888 ↗
• MalfunctionSep 9, 2021Crack; Failure to Advance; Mechanical Jam; Scratched Material; Crack; Failure to Advance; Mechanical Jam; Scratched Material

  IT WAS REPORTED THE PRE-LOADED INTRAOCULAR LENS (IOL) HAD LENS SCRATCH, LOADING, STUCK IN CARTRIDGE AND CARTRIDGE TIP CRACKED/DEFORMED ISSUES. THE CARTRIDGE TIP HAD CONTACT WITH THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE PROCEDURE WAS COMPLETED USING ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12444839 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A POST-LASIK PATIENT ENDED UP OFF TARGET AND AN EXPLANT/EXCHANGE OF THE INTRAOCULAR LENS (IOL) FOR A BETTER POWER IOL IS PLANNED. THROUGH FOLLOW-UP EXPLANT OF THE IOL WAS CONFIRMED. REPORTEDLY, THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11891984 ↗