TECNIS IOL DIU225 (REF DIU225U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474747166), received between Aug 25, 2022 and Dec 10, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF BLURRY VISION AND OVERCORRECTION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; INFORMATION REGARDING THE REPLACEMENT IOL WAS NOT PROVIDED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THE FOLLOWING ARE ALL UNKNOWNS: INCISION ENLARGEMENT, MEDICAL ATTENTION, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), PROCEDURAL DELAYS, SUTURES, AND VITRECTOMY. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23774940 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES, THE PATIENT EXPERIENCED GLARE FROM HEADLIGHTS AND BRIGHT LIGHT DISBURSEMENTS SURROUNDING OBJECTS AT NIGHT AND WHILE DRIVING, ALONG WITH GIANT SIZE LIGHT AREAS BEING EMITTED FROM THE LENS AT NIGHT DIMINISHING THE ABILITY TO PERCEIVE SPEED AND DISTANCE. THE PATIENT ALSO EXPERIENCED PERIPHERAL GLARE FROM OFFICE BACKGROUND LIGHTING AND PERIPHERAL LIGHT FROM THE SUN WHICH CAUSED THE LENS EDGE TO BE NOTICEABLE CAUSING VISION TO HAVE PERIMETER INTERFERENCE FROM THE LENS. ADDITIONALLY, THE PATIENT EXPERIENCED SEEING BRIGHT SPOTS AND HALOS AROUND LIGHTS APPEARING DURING COMPUTER MONITOR USE AND IT WAS NOTED THAT THE LENSES FAIL TO FUNCTION WITH LED COMPUTER MONITOR SPECTRUM. THE PATIENT FURTHER REPORTED THAT THE CENTER PRISM OF BOTH OPTICS IS APPARENT AND INTERFERES WITH VISION WHILE WORKING. THE SYMPTOMS WERE FIRST NOTED IMMEDIATELY AFTER SURGERY, WHICH WAS REPORTED TO THE DOCTOR WITHIN HOURS. THE PATIENT SOUGHT A SECOND AND THIRD CLINICAL OPINION, WHICH INDICATED THAT SURGERY WOULD NOT RESOLVE THE ISSUES. NO INTERVENTIONS WERE INDICATED OR REPORTED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23589849 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT REPORTED BLURRINESS, HE CAN SEE DISTANCE BUT CAN NOT READ AND HIS DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. HE CAN SEE REALLY GOOD UP CLOSE, BUT ANYTHING MIDRANGE IS NOT GOOD AT ALL AND THAT IS WHAT BOTHERS HIM. HE NEEDS TO BE ABOUT 12 INCHES AWAY FROM THE SCREEN TO SEE WELL. THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE; THE INFORMATION REGARDING A REPLACEMENT IOL IS UNKNOWN. THERE WAS NO MEDICAL ATTENTION, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. VISION PRE-OPERATIVE WAS REPORTED AS 20/200 HOWEVER, VISION POST-OPERATIVE IS UNKNOWN. PATIENT PROGNOSIS POST LENS EXCHANGE IS ALSO UNKNOWN. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22391996 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DISLOCATED POST IMPLANTATION. THE IOL WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 21329510 ↗
• MalfunctionJan 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS IMPLANTED, BUT THE HAPTICS WERE STUCK TOGETHER. THE SURGEON HAD TO USE A SECOND INSTRUMENT TO SEPARATE THE HAPTICS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085884 ↗
• InjuryOct 25, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  THE SURGERY CENTER REPORTED LENS MALFUNCTION DURING INSERTION OF A MONOFOCAL TORIC INTRAOCULAR LENS (IOL) INTO A PATIENT'S RIGHT EYE. THAT HAPTICS STUCK TOGETHER ON THE PRELOADED IOL. THE LENS WAS ABLE TO BE MANIPULATED TO WHERE HAPTICS OPENED, BUT THE HAPTICS POPPED OPEN AN CAUSED A CAPSULAR TEAR. THE DOCTOR WAS NOT ABLE TO ROTATE THE LENS INTO POSITION WITHOUT CAUSING IT TO FALL TO BACK OF THE EYE. A VITRECTOMY WAS PERFORMED AND THE PATIENT IS STABLE (IT IS NOT 20/30 UNCORRECTED POST-OP, DAY-3). PATIENT TO BE CORRECTED WITH GLASSES. RETINA EXAM DONE AND EYE LOOKS GOOD. THE VISCOELASTIC PRODUCT USED AT ROOM TEMPERATURE, IMMEDIATELY AFTER PREPARING. THE ISSUE DID NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES. NO OTHER SURGICAL OR MEDICAL INTERVENTIONS REQUIRED OR ARE PLANNED AND THEY ARE STILL OBSERVING THE PATIENT. THE PATIENT'S OUTCOME STATUS WAS INDICATED TO HAVING ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Macular Edema

  MAUDE report 20534927 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE. THE REASON FOR THE EXPLANT WAS NEGATIVE DYSPHOTOPSIA. THE ISSUE WAS NOTICED DURING A POSTOP EXAM. DIRECTIONS FOR USE WERE FOLLOWED. THE IOL WAS REPLACED WITH A NON JNJ LENS MODEL SOFTEC HDO +20.75 DIOPTER. THE PATIENT HAS FULLY RECOVERED. THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. THE REPORTED SYMPTOMS LASTED 4 MONTHS AND 26 DAYS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19795066 ↗
• MalfunctionApr 16, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS HAD A MISSING ENTIRE HAPTIC, AND THE SURGEON COULD NOT REMOVE THE LENS DUE TO ZONULAR WEAKNESS. ISSUE FIRST IDENTIFIED DURING IMPLANTATION AND APPLICATION. IT IS UNKNOWN IF THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Zonular Dehiscence

  MAUDE report 19113492 ↗
• MalfunctionAug 25, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT UPON INSERTION INTO THE PATIENT'S LEFT EYE THE INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE LENS WAS FULLY INSERTED AND REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER AS THE REPLACEMENT LENS. THERE WAS NO PATIENT INJURY. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299268 ↗