TECNIS IOL DIU150 (REF DIU150U130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474746404), received between Jun 17, 2022 and Apr 17, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING VISION IN BOTH EYES FOLLOWING IMPLANTATION OF PRELOADED MONOFOCAL TORIC INTRAOCULAR LENSES (IOLS). THE PATIENT REPORTED SIGNIFICANT LIGHT SENSITIVITY, PARTICULARLY AT NIGHT WHILE DRIVING, WITH HEADLIGHTS CAUSING SEVERE IRRITATION, AS WELL AS PERSISTENT DOUBLE VISION AND POOR DISTANCE VISION IN THE RIGHT EYE. THE PATIENT STATED THAT THESE SYMPTOMS BEGAN IMMEDIATELY AFTER THE SURGICAL PROCEDURES, ALTHOUGH THE EXACT SURGERY DATES WERE NOT PROVIDED. THE PATIENT ALSO REPORTED EXPERIENCING STARBURST EFFECTS PRIOR TO SURGERY; HOWEVER, FOLLOWING CATARACT SURGERY, THE STARBURSTS BECAME SIGNIFICANTLY BRIGHTER AND MORE PRONOUNCED, INCREASING SUBJECTIVELY FROM APPROXIMATELY FIVE TO FIFTY STARBURSTS, DESCRIBED AS CLEARER AND MORE VIBRANT. THE PATIENT WAS PRESCRIBED EYE DROPS, INCLUDING PREDNISOLONE ACETATE, BEGINNING ON MARCH 18, 2026, WHICH REPORTEDLY IMPROVED PAIN AND LIGHT SENSITIVITY. DURING A FOLLOW UP VISION EVALUATION ON (B)(6), 2026, THE PATIENT CONTINUED TO REPORT POOR VISION AND DOUBLE VISION IN THE RIGHT EYE, WHILE THE LEFT EYE WAS REPORTED TO HAVE GOOD VISION. THE PHYSICIAN INITIALLY SUGGESTED THAT THE INTRAOCULAR LENS IN THE RI

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 24918622 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIU150, WAS RECEIVED WITH A BLOODY FINGERPRINT ON THE BOX. THE PRODUCT WAS NOT OPENED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384721 ↗
• InjuryJun 2, 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 PATIENT'S LEFT EYE DUE TO OTHER DISORDERS OF THE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 22128569 ↗
• MalfunctionMay 20, 2025Break; Break

  FOLLOWING INSERTION THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS FOUND TO BE CRACKED WHILE UNFOLDING IN THE EYE. THE IOL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO PATIENT INJURY HOWEVER, IT IS UNKNOWN IF ANY MEDICAL INTERVENTION OR SURGICAL INTERVENTION WAS REQUIRED DURING THE PROCEDURE. THE IOL WAS PREPPED FOR ABOUT FIVE (05) MINUTES PRIOR TO INSERTION AND IT IS UNSURE IF BALANCED SALT SOLUTION (BSS) OR OPHTHALMIC VISCOSURGICAL DEVICE - VISCOELASTIC (OVD) WAS USED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS SEEMED STABLE AND NORMAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057609 ↗
• InjuryFeb 25, 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 AND REPLACED WITH THE SAME MODEL LENS WITH SAME DIOPTER IN THE SECONDARY PROCEDURE. THIS WAS DUE TO A FLIPPED CYLINDER AFTER SURGERY. THERE WAS NO PATIENT INJURY. THERE WERE NO DAILY ACTIVITIES AFFECTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462987 ↗
• InjuryJun 17, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXPLANT DUE TO THE INTRA-OCULAR LENS (IOL) IN THE RIGHT EYE ROTATING 40 DEGREES AND THE POWER BEING OFF. A REPLACEMENT LENS OF THE SAME MODE, BUT DIFFERENT DIOPTER (14.0) WAS USED. THERE WAS NO REPORTED PATIENT INJURY. THE PAIENT IS DOING GOOD POST-OP. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14725814 ↗