TECNIS IOL DIU225 (REF DIU225U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474747159), received between Dec 8, 2022 and Mar 12, 2026 — classified as 3 injuries, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break; Use of Device Problem; Ejection Problem

  IT WAS REPORTED THAT A SINGLE-PIECE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE. DURING INSERTION, IT WAS OBSERVED THAT THE TRAILING HAPTIC BECAME ENTANGLED AROUND THE INSERTER. THE SURGEON ATTEMPTED TO DISENGAGE THE HAPTIC USING A TYER TOOL; HOWEVER, THE HAPTIC FRACTURED DURING THIS MANEUVER. THE AFFECTED IOL WAS EXPLANTED AND REPLACED WITH A BACKUP IOL OF THE SAME MODEL AND DIOPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581993 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. THE PATIENT EXPERIENCED A MYOPIC SHIFT WHICH WAS IMPACTING THEIR DAILY ACTIVITIES. THE IOL WAS EXPLANTED AND REPLACED. THE REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, OR SUTURES. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION REGARDING THIS EVENT IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 24229188 ↗
• InjuryApr 29, 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 THE PATIENT'S LEFT EYE AFTER TWO MONTHS OF IMPLANTATION. THE PATIENT REPORTED INTOLERABLE DYSPHOTOPSIA AND LOSS OF BEST CORRECTED VISION. IT WAS STATED THAT THE SYMPTOMS STARTED AS OF DAY ONE POST OP, BLURRED VISION, GHOSTING, BLUE TINT, VIBRATING EYE, HEADACHES AND HIS SIDE VISION HAD AN IRRITATING SHARP LIGHT. THESE SYMPTOMS DID NOT IMPROVE AT 1 WEEK OR AT FUTURE APPOINTMENTS. LENS WAS REPLACED WITH THE SAME MODEL AND SAME DIOPTER LENS IN A SECONDARY PROCEDURE. THERE WAS NO CALCULATION ISSUE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. PATIENT'S DAILY ACTIVITIES ARE NOT AFFECTED. THE PATIENT IS DOING GOOD. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Headache; Unspecified Eye / Vision Problem; Visual Disturbances; Visual Impairment

  MAUDE report 19210371 ↗
• MalfunctionFeb 16, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. REPORTEDLY, IT¿S UNKNOWN IF THE IOL TOUCHED THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389183 ↗
• InjuryDec 8, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED AND REMOVED FROM THE RIGHT EYE BECAUSE A VITRECTOMY WAS NEEDED. PER THE DOCTOR, THERE WAS A POSTERIOR DEFECT NOTED IN THE CAPSULAR BAG AND DUE TO INSTABILITY OF THE LENS, THE DECISION WAS MADE TO EXPLANT. THE INSTABILITY OF THE LENS WAS DUE TO A CAPSULAR DEFECT. THERE WAS NO PRODUCT ISSUE. THE ISSUE WAS FIRST OBSERVED AFTER THE LENS WAS FULLY IMPLANTED AND THEN IT WAS CUT OUT AND REPLACED WITHIN THE SAME PROCEDURE. THE INCISION WAS ENLARGED AND ONE SUTURE AND A VITRECTOMY WERE REQUIRED. A NON-JOHNSON AND JOHNSON THREE-PIECE IOL WAS IMPLANTED AS REPLACEMENT. THE REPLACEMENT LENS WAS "DIALED IN" WITHOUT ISSUE. THE DOCTOR DOES NOT KNOW IF THE "DEFECT" WAS A RESULT OF THE ATTEMPT TO IMPLANT THE IOL OR IF IT WAS A PATIENT BIOLOGICAL ISSUE. THE PATIENT WAS DOING WELL AT THE POST-OP VISIT. NO FURTHER INFORMATION IS AVAILABLE WAS PROVIDED.

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

  MAUDE report 15943491 ↗