TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474811317), received between Nov 14, 2024 and May 7, 2026 — classified as 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD IOL IMPLANTED IN LEFT EYE ON (B)(6) 2025 AND REPORTED THAT SHE DOES NOT WEAR GLASSES AS SHE IS PLEASED WITH HER VISION. HOWEVER, SHE IS EXPERIENCING HALOS, LITTLE LINES COMING OUT WHEN SHE SEES LIGHTS AT NIGHT. THIS IS OCCURRING IN BOTH EYES. THE PATIENT SAID THAT HER DOCTOR IS TESTING AND MAPPING HER EYES AND REPORTED HAVING PRK (PHOTOREFRACTIVE KERATECTOMY) WHICH SHE CALLED ¿ZAPPING¿ TWICE. ACCORDING TO THE PATIENT, THE PROCEDURE IS TO SHAVE PART OF THE CORNEA OFF. REPORTEDLY, A CONTACT LENS WAS PUT ON TOP OF IT TEMPORARILY. AT THE TIME OF THIS REPORT, THE PATIENT SAID SHE IS HAVING AN UPCOMING PROCEDURE THAT IS PROBABLY TO REMOVE THE CONTACT LENS OR PRK. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP TO GET CLARIFICATION ON THE REPORTED EVENT BUT THE CUSTOMER HAS NOT RESPONDED. NO FURTHER INFORMATION IS AVAILABLE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT'S RIGHT EYE.

  Patient problems: Flashers; Halo

  MAUDE report 25114190 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S IN THE PATIENT'S EYE. POST-OPERATIVELY THE PATIENT REPORTED SYMPTOMS OF BLURRY VISION, HALOS, GLARE, AND EYE IRRITATION, WHICH HAVE PERSISTED FOR TEN (10) MONTHS DESPITE THE USE OF PRESCRIBED EYE DROPS FOR DRY EYE. THESE ISSUES HAVE AFFECTED HER ABILITY TO READ, DRIVE, AND WORK AS A HOME HEALTH REGISTERED NURSE. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 24587525 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO PATIENT COMPLAINTS OF DIFFICULTY WITH GLARE AND BLURRED VISION WHILE DRIVING AT NIGHT, AND DIFFICULTY WITH READING, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; REPLACEMENT IOL INFORMATION IS UNKNOWN. THERE ARE NO DAILY ACTIVITIES THAT THE PATIENT CANNOT PERFORM THAT HE WAS ABLE TO PRIOR TO THE SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23733537 ↗
• InjuryAug 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF IOL MECHANICAL COMPLICATIONS, DID NOT WORK AS INTENDED, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 20.0 IOL. PATIENT'S PRE-OPERATIVE BSCVA WAS 20/40 AND REFRACTION WAS -0.75+1.00X170, POST-OPERATIVE BSCVA WAS 20/25+1 AND REFRACTION: +1.00+0.50X90. INTENDED TARGET REFRACTION WAS PLANO. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22879956 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT THE CARTRIDGE OF THE PRELOADED INTRAOCULAR LES (IOL) WAS FAULTY. THE LENS WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH SAME MODEL AND SAME DIOPTER LENS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS WAS PARTIALLY INSERTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118598 ↗
• InjuryNov 14, 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 AND REPLACED WITH NON PRELOADED INTRAOCULAR LENS ZCU225 WITH18.5D. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 20686090 ↗