TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474811331), received between May 12, 2025 and Feb 13, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionFeb 13, 2026Break; Crack

  IT WAS REPORTED THAT THE INJECTOR ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) SPLIT UPON INSERTION OF THE LENS RESULTING IN THE IOL BEING FRACTURED. THE FRACTURED ON THE LENS OCCURRED PRIOR TO INSERTING INTO THE EYE. CONSEQUENTLY, THE IOL WAS REMOVED WITH NO HARM TO THE PATIENT. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP TO GET ADDITIONAL DETAILS, BUT A RESPONSE HAS NOT BEEN RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340173 ↗
• MalfunctionFeb 13, 2026Break; Crack

  IT WAS REPORTED THAT THE INJECTOR ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) SPLIT UPON INSERTION OF THE LENS RESULTING IN THE IOL BEING FRACTURED. THE FRACTURED ON THE LENS OCCURRED PRIOR TO INSERTING INTO THE EYE. CONSEQUENTLY, THE IOL WAS REMOVED WITH NO HARM TO THE PATIENT. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP TO GET ADDITIONAL DETAILS, BUT A RESPONSE HAS NOT BEEN RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340162 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE ISSUE WAS IDENTIFIED DURING THE FOLLOW-UP EXAMINATION. THE IOL REMAINS IMPLANTED, AND THE DOCTOR HAS NO PLANS TO REMOVE IT. THERE WAS NO UNPLANNED INCISION ENLARGEMENT AND NO SUTURES. IT IS UNKNOWN IF THERE WAS AN UNPLANNED VITRECTOMY. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S POST-OPERATIVE VISUAL ACUITY OUTCOME IS UNKNOWN. REPORTEDLY, NO OTHER PATIENTS RECEIVED THIS LENS, AND NO OTHER ISSUES WERE REPORTED IN THE OPERATING ROOM. THE PATIENT STATES THAT THE EYE IS SORE AND PAINFUL. VISION IS BAD. THE PATIENT¿S VISUAL OUTCOME WAS REPORTED AS ¿CURRENTLY BEING TREATED.¿ THE FOLLOWING TREATMENT WAS REQUIRED FOR TASS. TOPICAL, SYSTEMIC, AND INTRAOCULAR MEDICATION, NO SUBCONJUNCTIVAL. PRESCRIPTION AND OVER THE COUNTER MEDICATION WAS REQUIRED. THE CUSTOMER DID NOT INDICATE IF THE MEDICATION WAS REQUIRED TO PRECLUDE PERMANENT INJURY AND DOSAGES WERE NOT PROVIDED. NO CULTURE OR PCR (POLYMERASE CHAIN REACTION) WAS PERFORMED. THE CUSTOMER DID NOT OBSERVE A PATTERN IN THEIR CASES AND ON THE DAY OF SURG

  Patient problems: Blurred Vision; Eye Pain; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 23327912 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD COMPLAINTS OF BLURRY VISION, HALOS, AND HAD DIFFICULTY DRIVING AT NIGHT. THE PRELOADED LENS WAS EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH THE SAME MODEL BUT WITH A LOWER DIOPTER CYLINDER POWER. THE PATIENT'S VISUAL ACUITY IS 20/25. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 22919517 ↗
• InjuryJul 2, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED, BUT VITREOUS ENTERED THE ANTERIOR CHAMBER, CAUSING THE IOL NOT TO SIT PROPERLY. THE IOL WAS PLACED AND THEN REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A IOL FROM ANOTHER MANUFACTURER. ADDITIONAL INFORMATION REVEALED THAT THE LENS DIDN¿T SEEM NORMAL AND WAS JAMMED IN THE CARTRIDGE. IT CAME OUT OF THE DEVICE DEFORMED AND UNUSABLE. THE PATIENT REQUIRED INCISION ENLARGEMENT AND AN UNPLANNED VITRECTOMY DUE TO A POSTERIOR CAPSULE TEAR. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22387289 ↗
• InjuryMay 12, 2025Adverse 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 PATIENT'S LEFT EYE AS THE PATIENT COMPLAINED OF VISION BEING VERY BLURRY AFTER 8 FEET. DAYTIME HALOS AROUND BRIGHT LIGHTS, AND HORRIBLE HALOS AT NIGHT. LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS IN SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WERE NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE BEST CORRECTED VISUAL ACUITY PRE-OP WAS 20/25, AND BEST CORRECTED VISUAL ACUITY POST-OP WAS 20/20. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 22006967 ↗