TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811270), received between Sep 25, 2024 and Sep 8, 2026 — classified as 3 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679877 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO BLURRY AND NON-CRISP VISION FOLLOWING THE INITIAL LENS IMPLANTATION. THE ORIGINAL LENS WAS REPLACED WITH A DIB00 LENS WITH 19.0 DIOPTER. NO CONCOMITANT JOHNSON & JOHNSON PRODUCTS WERE UTILIZED DURING THE PROCEDURE THAT CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO HARM TO THE PATIENT OR USER REPORTED. THE PRODUCT IS NOT AVAILABLE FOR RETURN OR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 24723027 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY PATIENT REPORTS COMPLAINTS CONSISTENT OF BLURRY NEAR VISION, GLARE HALOS, AND STARBURSTS THAT HAVE NOT IMPROVED OVER TIME OR WITH DRY EYE THERAPY. THERE IS NO PATIENT HARM. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Dry Eye(s); Flashers; Halo; Visual Disturbances

  MAUDE report 24646379 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT WHO HAD A MULTIFOCAL INTRAOCULAR LENS (IOL) IN HIS LEFT EYE REPORTED THAT HIS SIGHT IS EXTREMELY BLURRY, WORSE AT NIGHT WHICH HAS NOT IMPROVED SINCE THE SURGERY. THE PATIENT MENTIONED HE HAS SOME RETINAL PATHOLOGY. THE PATIENT SOMETIMES SEES CLEAR AND SOMETIMES DOES NOT. TODAY ((B)(6) 2024), WHEN THE PATIENT WENT OUT IN (B)(6), THE AIR OUTSIDE WAS CLEAR, HE WAS ABLE TO SEE EVERYTHING CLEARLY. THEN WHEN HE RETURNED HOME, IT WAS NOT CLEAR AND HE WOULD SEE BLURRY. THE PATIENT SAW HIS DOCTOR TWO WEEKS AGO ((B)(6) 2024) WHO ADVISED THE PATIENT TO USE OVER THE COUNTER, REFRESH TEARS EYE DROP WHICH THE PATIENT CLAIMED HE CANNOT TELL ANY DIFFERENCE. THE PATIENT INDICATED WHEN HE TALKED TO OTHERS ABOUT DRY EYE, THEY STATE THAT THEY WOULD FEEL IT WHEN THEIR EYES ARE DRY, BUT THE PATIENT DOES NOT FEEL HIS EYES ARE DRY. THE PATIENT CONFIRMED HE IS ABLE TO PERFORM HIS DAILY ACTIVITIES AND HE WORKS AS HE HAS TOO, BUT AT NIGHT TIME, HE DOES NOT DRIVE SINCE HE CANNOT SEE WHEN IT IS DARK. SO, THE PATIENT WALKS TO STORES AT NIGHT TIME AND DOES NOT DRIVE. THE PATIENT IS HAVING A POST-OP APPOINTMENT ON (B)(6) 2024. SINCE THE LENS IS A MULTIFOCAL TORIC, THE PATIENT EXPECTED TO SEE NEAR,

  Patient problems: Blurred Vision

  MAUDE report 20302968 ↗