TECNIS IOL DIU225 (REF DIU225U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474747111), received between Jan 25, 2022 and Sep 10, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEADING HAPTIC ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) TORE THE CAPSULAR BAG UPON INSERTION. THE ISSUE OCCURRED IN TWO CASES IN TWO SEPARATE SURGERY CENTERS. THIS REPORT CAPTURES THE FIRST CASE SERIAL #: (B)(6). REPORTEDLY, THE DOCTOR IS NOT DOING ANYTHING DIFFERENT. THE DOCTOR THOUGHT IT MIGHT BE HER BUT IN HER SECOND CASE WHICH IS MORE RECENT, SHE INJECTED OPHTHALMIC VISCOSURGICAL DEVICE (OVD) INTO THE CARTRIDGE AND THE BAG WAS COMPLETELY INFLATED WITH OVD. NO RESISTANCE WAS FELT UPON INSERTION. NO VITRECTOMY WAS NEEDED. THE IOL REMAINS IMPLANTED WITH NO COMPLICATIONS. WE ARE FOLLOWING-UP TO GET MORE DETAILS AND DISTINCTION BETWEEN THE TWO EVENTS HOWEVER, THE CUSTOMER HAS NOT RESPONDED. NO FURTHER INFORMATION WAS PROVIDED. NOTE. THE INFORMATION FOR THE SECOND CASE SERIAL #: (B)(6) IS BEING SUBMITTED IN A SEPARATE. MEDWATCH REPORT, CASE (B)(4).

  Patient problems: Capsular Bag Tear

  MAUDE report 20177642 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE AS THE PATIENT NOTED BLURRY VISION 1-MONTH POST OP, SEES THINGS FLOATING AND LACK OF CRISPNESS AT DISTANCE. IT WAS NOTED THAT PATIENT'S DAILY ACTIVITIES SIGNIFICANTLY AFFECTED. VISION PRE-OPERATIVE, CORRECTED WAS 20/25 AND VISION POST-OPERATIVE (BEFORE IOL EXCHANGE) WAS 20/30. THERE WAS NO VITRECTOMY PERFORMED, NO SUTURES REQUIRED AND NO DELAY IN PROCEDURE REPORTED. THE MEDICATION PRESCRIBED WAS PREDNISOLONE. THE PATIENT'S STATUS IS UNKNOWN. IT WAS INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 19188453 ↗
• MalfunctionDec 11, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN EYHANCE TORIC II INTRAOCULAR LENS (IOL) PRIOR TO ACTUAL INSERTION APPEARED SCRATCHED IN TWO SEPARATE AREAS. THIS WAS NOT BELIEVED TO HAVE OCCURRED DURING ADVANCING OR HANDLING. THIS IOL IS PRE-LOADED, SO NO CARTRIDGE WAS USED, AND NO INJECTOR HANDPIECE WAS NECESSARY. NO DAMAGE TO THE CARTRIDGE TIP. IT WAS STATED THAT OVD WAS USED. AND THAT OVD WAS ALLOWED TO ACCLIMATIZE FULLY TO OPERATING ROOM TEMPERATURE. NO DELAYS IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS IT WAS NOTED THAT THE SCRATCHES WERE TOO SMALL TO SEE DURING LOADING, AND NOT FOUND UNTIL LENS WAS VIEWED UNDER THE MICROSCOPE. THERE WAS NO PATIENT CONTACT. ANOTHER JOHNSON AND JOHNSON IOL WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302868 ↗
• InjuryMay 17, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT EYE HAD SCUFF MARKS. THE PATIENT ALSO SUFFERS FROM INDUCED BLUR FROM HIGHER ORDER ABERRATIONS WITH THE EYHANCE LENS. AN EXCHANGE IS PLANNED FOR A ZCU TORIC MODEL LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE EYHANCE LENS WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A DIFFERENT MODEL AND LOWER DIOPTER (ZCU150 18.5) JOHNSON & JOHNSON IOL. THE PATIENT WAS TAKEN TO RECOVERY WITH NO COMPLICATIONS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT'S VISION POST-OPERATIVELY DAY (POD) #1 MEASURED 20/20. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 14414644 ↗
• MalfunctionApr 22, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SIMPLICITY INTRAOCULAR LENS (IOL) HAS A SCUFF AFTER BEING INSERTED INTO THE PATIENT'S CAPSULAR BAG. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190219 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 13350801 ↗