TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474811195), received between Dec 26, 2024 and Nov 17, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 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 SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT REPORTED ALL LETTERS/WORDS HAVE A SHADOW AURA AROUND THEM, DISTANCE AND NEAR VISION ARE NOT CLEAR, DIFFICULTY READING, HALOS AROUND LIGHTS, AND DIFFICULTY WITH GLARE. VISION PRE-OPERATIVE WAS 20/50 AND POST-OPERATIVELY WAS 20/60-2. THUS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 12.0 DIOPTER IOL. THERE WAS NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE HOWEVER IT IS UNKNOWN IF THE INCISION WAS ENLARGED OR IF SUTURES WERE REQUIRED. MEDICAL ATTENTION WAS REQUIRED AND PREDNISOLONE ACETATE MEDICATION WAS PRESCRIBED. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 23576343 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO EXCESSIVE GLARE. THE IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON LENS MODEL INVISTA INSPIRE 14.0 DIOPTER. THERE WERE NO PATIENT INJURIES SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THERE WERE NO PRESCRIBED MEDICATIONS REQUIRED TO PREVENT PERMANENT INJURY. THE PATIENT¿S OUTCOME WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 21349601 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT AND LEFT EYE THE PATIENT EXPERIENCED SEVERAL POST-OPERATIVE COMPLICATIONS. FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED NEW SYMPTOMS IN BOTH EYES, INCLUDING VISUAL HALLUCINATIONS SUCH AS SEEING GEOMETRIC SHAPES, TREES, HILLS, FACES, AND RED WRITING ON WALLS, WHICH THE SURGEON NOTED SOUNDS LIKE CHARLES BONNET SYNDROME. TO ALLEVIATE DISCOMFORT, THE PATIENT HAS BEEN WEARING SUNGLASSES FULL-TIME SINCE SURGERY. THE PATIENT SPEND SIX DAYS AT THE EMERGENCY ROOM (ER) DUE TO EMOTIONAL DISTRESS AND VISUAL DISTURBANCES (SELF-CHECKED IN). A MAGNETIC RESONANCE IMAGING (MRI) WAS CONDUCTED AND SHOWED NO ABNORMALITIES (WITHIN NORMAL LIMITS). PSYCHIATRIC CONDITIONS, HALLUCINATIONS, AND MENTAL ILLNESS WERE ALL RULED OUT. THE PATIENT HAS BEEN ADVISED TO FOLLOW UP WITH NEURO-OPHTHALMOLOGY AND THERE IS A PLAN FOR AN INTRAOCULAR LENS EXCHANGE FROM A MULTIFOCAL TO STANDARD LENS. ADDITIONALLY, THE PATIENT HAS DEVELOPED POSTERIOR VITREOUS DETACHMENT IN BOTH EYES, A NEW CONDITION SINCE THE SURGERY, AND EXPERIENCES MONOCULAR DIPLOPIA IN BOTH EYES, WHICH WAS CONFIRMED ON (B)(6) 2024. CURRENTLY, TH

  Patient problems: Distress; Visual Disturbances; Visual Impairment; Vitreous Detachment

  MAUDE report 21021311 ↗