TECNIS IOL DIU375 (REF DIU375U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474748347), received between Mar 10, 2022 and Aug 2, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2022Unstable; Unstable

  A MALE PATIENT REPORTED THAT HE WAS IMPLANTED WITH A LOWER END INTRAOCULAR LENS (IOL) INSTEAD OF GETTING A BETTER IOL. THAT THE PHYSICIAN TOLD HIM, HE WOULD NOT WEAR GLASSES ANYMORE, BUT THE PATIENT IS STILL WEARING GLASSES AND IS NOT SATISFIED WITH HIS VISION. THE PATIENT SAW HIS DOCTOR RECENTLY AND WAS INFORMED THAT THE LENS IN THE RIGHT EYE HAS ROTATED 11 DEGREES AND THE LENS IN THE LEFT EYE HAS ROTATED 6 DEGREES. THE PATIENT STATED THAT HE IS EXPERIENCING BLURRY VISION, FLOATERS AND STARBURST IN BOTH EYES. THE PATIENT HAS DIFFICULTIES WITH DRIVING, READING AND SEEING THINGS; HOWEVER, HE ACCEPTS THAT HE IS STILL ABLE TO DO HIS DAILY TASKS ALTHOUGH SOMETIMES WITH DIFFICULTY. THE PATIENT WAS SEEN BY HIS DOCTOR ON (B)(6) 2022 WHICH RE-ROTATION AND FLATTENING OF THE RIGHT EYE LENS WAS PERFORMED DURING THAT VISIT. NO ACTION WAS TAKEN WITH THE LEFT EYE. THE PATIENT INDICATED THAT THE RE-ROTATION HAS NOT MADE MUCH DIFFERENCE. THE PATIENT IS SCHEDULED TO SEE HIS DOCTOR AGAIN ON (B)(6) 2022. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Vitreous Floaters

  MAUDE report 15153831 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S VISION WAS NOT CRISP, HAD BLURRY DISTANCE VISION, AND GLARE AT NIGHT AFTER THE IMPLANTATION OF THE TECNIS EYHANCE INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE. THE PATIENT'S OUTCOME WAS MYOPIC. THE SYMPTOMS WERE FIRST REPORTED TO THE SURGEON AT 1 DAY POST-OPERATIVE (OP) VISIT. VISUAL ACUITY (VA) PRE-OP: 20/30 -2 AND VA POST-OP: 20/30. LASIK WAS DONE STATUS POST, BUT THE PATIENT'S VISION DID NOT IMPROVE. THUS, AN EXPLANT WAS PERFORMED. THE INCISION WAS ENLARGED, HOWEVER, SUTURES AND A VITRECTOMY WERE NOT REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 13726439 ↗