TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811201), received between Nov 26, 2024 and Jan 26, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS BROKEN. THE PRODUCT DID NOT CONTACT THE EYE. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, SUTURES, OR MEDICATION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186180 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT WHO EXPERIENCED DOUBLE VISION, FROST FILM, HAZINESS, AND VERY BLURRED VISION ON POSTOPERATIVE DAY 8. DESPITE MEDICAL INTERVENTIONS, INCLUDING TAP AND INJECTION, THE SYMPTOMS PERSISTED, LEADING TO THE EXPLANTATION OF THE DEVICE ON (B)(6) 2025. NO REPLACEMENT LENS WAS IMPLANTED, AND THE PATIENT WAS LEFT APHAKIC, WITH NO PLANS TO IMPLANT AN ADDITIONAL LENS. THE PATIENT OUTCOME STATUS WAS REPORTED AS STILL BEING SEEN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Endophthalmitis; No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 23330934 ↗
• MalfunctionSep 11, 2025Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE ODYSSEY TORIC INTRAOCULAR LENS (IOL) GOT STUCK HALF WAY, WHILE INSERTING INTO THE PATIENT'S LEFT EYE. THE PUSHER WENT TO THE RIGHT AND PINCHED THE LENS MAKING IT STUCK. THE LENS WAS PARTIALLY INSERTED AND THE SURGEON USED FORCEPS TO PULL LENS OUT OF INCISION WITHOUT ANY INCIDENT AND PROCEDURE WAS COMPLETED WITH A BACK UP LENS. THERE WAS NO USE ERROR, THE INJECTOR MESSED UP. NO MEDICAL/SURGICAL INTERVENTION REQUIRED. UPON FURTHER FOLLOW UP, IT WAS LEARNT THAT LENS WAS PARTIALLY INSERTED AND THE SURGEON USED FORCEPS TO PULL LENS OUT OF INCISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031833 ↗
• MalfunctionNov 26, 2024Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS A FOREIGN MATERIAL PRESENT ON THE OPTIC OF THE PRELOADED TORIC INTRAOCULAR LENS (IOL) FROM THE TIME THE IOL WAS INSERTED. THE PHYSICIAN ATTEMPTED TO REMOVE THE FOREIGN OBJECT USING IRRIGATION/ASPIRATION, A HOOK, AND OTHER METHODS, BUT WAS UNABLE TO EXTRACT IT. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779898 ↗