TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474811324), received between Feb 25, 2025 and May 21, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse 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 COMPLAINED OF DYSPHOTOPSIA, HALOS AND GLARE. CONSEQUENTLY, THE IOL WAS EXPLANTED. REPORTEDLY, THERE WAS NO PATIENT OR USER HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25241353 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD IOL IMPLANTED IN RIGHT 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 LEFT EYE.

  Patient problems: Flashers; Halo

  MAUDE report 25114245 ↗
• MalfunctionApr 5, 2026Scratched Material

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS SCRATCHED UPON INSERTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787120 ↗
• 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 24586965 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF THE PRELOADED TORIC INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED BLURRY VISION. THE IMPLANTED LENS WAS SUBSEQUENTLY EXCHANGED FOR AN IOL OF A DIFFERENT POWER. THE PATIENT HAS SINCE HEALED AND IS SATISFIED WITH THE FINAL VISUAL OUTCOME. FOLLOW-UP CONFIRMED THAT AN INCORRECT IOL POWER WAS IMPLANTED IN THE RIGHT EYE, RESULTING IN UNDER CORRECTION AND A LOSS OF TWO OR MORE LINES OF BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA). PRE-OPERATIVE REFRACTION WAS -4.50 +0.50 × 45 WITH A BSCVA OF 20/20. POST-OPERATIVE REFRACTION WAS -3.00 +0.50 × 107 WITH A BSCVA OF 20/20. THE INTENDED TARGET REFRACTION WAS PLANO. THE REPLACEMENT IOL USED DURING THE EXCHANGE PROCEDURE WAS NOT A JOHNSON & JOHNSON LENS. FOLLOWING THE EXCHANGE, THE PATIENT ACHIEVED A POST-OPERATIVE VISUAL ACUITY OF 20/25. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR THE PLACEMENT OF SUTURES WERE REQUIRED. NO PRE-EXISTING CONDITIONS AFFECTING IOL POWER CALCULATION WERE REPORTED, AND NO EVIDENCE OF PATIENT HARM WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24471097 ↗
• InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DURING A SECONDARY SURGICAL PROCEDURE FOR UNKNOWN REASONS. THE FOLLOWING ARE ALSO ALL UNKNOWNS: REPLACEMENT IOL INFORMATION AND PATIENT PROGNOSIS POST LENS EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23627950 ↗
• InjuryApr 21, 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 RIGHT EYE AS THE PATIENT COMPLAINED OF STARBURST, HALOS, BLURRED VISION AT ALL DISTANCES. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH DRN00V LENS. PATIENT DOING BETTER NOW. PATIENT CLAIMED VISION WAS IMPROVING. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT LENS HAD CONTRIBUTED FOR BLURRED VISION, HALOS AND STARBURSTS. THE DAILY ACTIVITIES OF THE PATIENT WERE AFFECTED. THERE WERE NO ANY DEBILITATING CONDITIONS WITH THE PATIENT. THE REPLACED LENS HAD SATISFIED/CORRECT THE PATIENT¿S ISSUES. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Flashers; Halo

  MAUDE report 21875535 ↗
• InjuryFeb 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT PHACO PROCEDURE AND A DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE DOCTOR: HIGH MYOPE (AL=24.61), HIGH CORNEAL DIAM. (13.0) AND LARGE CAPSULAR BAG -> CTR PLACED. POST-OPERATIVELY, THE IOL TEMPORALLY DECENTERED (< 1MM) AND THERE WAS A MILD POST-OP REFRACTION ERROR. POST-OP VISUAL ACUITY WITHOUT CORRECTION (VASC) WAS REPORTED AS 20/70-. RFX WAS REPORTED AS +.75-75X175=20/30+3. PATIENT WAS PROBABLY MILDLY AMBLYOPIC OD AND WAS UNAWARE. PATIENT ALSO STATES DOING "PENCIL PUSHUPS" AT AGE 7. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT225 19.0 DIOPTER IOL. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION DURING THE EXPLANT PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS GREAT AND NEXT DAY POST-OP, VA WAS REPORTED AS 20/40 SC. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 21465260 ↗