TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474811362), received between May 13, 2025 and Mar 14, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2026Scratched Material

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, NOTING THAT IT APPEARED TO HAVE MARKS ACROSS ITS SURFACE, DESCRIBED AS ¿LIKE A BEAR CLAWED IT. THE LENS WAS INITIALLY IMPLANTED INTO THE PATIENT'S LEFT EYE , BUT ONCE THE SURGEON RECOGNIZED THE MARKS, IT WAS REMOVED AND REPLACED WITH ANOTHER LENS SAME MODEL AND DIOPTER. ACCOUNT STATED THAT NO PATIENT INJURY WAS REPORTED. NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS¿SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES¿WERE REQUIRED. THE PATIENT WAS RECOVERING WELL WITH NO POST-OPERATIVE ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600370 ↗
• InjuryDec 18, 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). POST OPERATIVELY, THE PATIENT REPORTS HER VISION HAS SLIGHTLY IMPROVED FROM BLURRY TO FUZZY SINCE THE INITIAL SURGERY. SHE IS UNABLE TO READ, HER EYE STINGS, AND FEELS TIRED; SHE DESCRIBED IT AS LIKE SHE HAD AN EYELASH IN HER EYE. AFTER RESTING, HER EYES FEEL BETTER BUT VISION IS STILL FUZZY. THE PATIENT ALSO REPORTS SENSITIVITY TO BRIGHT COLORS, WHICH HAS LED HER TO UNSCREW LIGHT BULBS IN HER HOME TO EASE THE DISCOMFORT. THE PATIENT ALSO EXPERIENCES DRY EYE, WHICH SHE WAS INFORMED IS A SIDE EFFECT, AND USES EYE DROPS FOR RELIEF AND SHE TAKES GABAPENTIN FOR OSTEOARTHRITIS. HER OPHTHALMOLOGIST CONFIRMED THAT THE LENSES WERE PLACED CORRECTLY, ADVISING THAT IT MAY TAKE 3-6 MONTHS FOR HER BRAIN TO ADJUST TO THE IMPLANTS. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Dry Eye(s); Eye Pain

  MAUDE report 23846914 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PRELOADED MULTIFOCAL IOL (MODEL DRT) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. POSTOPERATIVELY, THE PATIENT EXPERIENCED DYSPHOTOPSIA WITH HALOS AND HAZY VISION, RESULTING IN DISSATISFACTION. IT WAS CONFIRMED THAT THE ISSUE DID NOT IMPACT PATIENT'S DAILY ACTIVITIES. THE LENS WAS EXPLANTED DURING A SECONDARY PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. PRE-OP REFRACTION: 0.75/0.25/030; POST-OP REFRACTION: +0.25/-1.25-170. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR ADDITIONAL MEDICATIONS WERE REQUIRED. THE PATIENT¿S OUTCOME IS GOOD AND NO INJURY REPORTED. NO FURTHER DETAILS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 23810444 ↗
• InjuryNov 25, 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 COMPLAINTS OF BLURRED VISION, GLARE AT BOTH DISTANCES AND READING, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 21.5 IOL. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/40 AND POST-OPERATIVE WAS 20/30. THE PATIENT¿S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE EXPLANT PROCEDURE. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED AND BCVA POST-OPERATIVE WAS 20/20-2. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23641040 ↗
• InjuryNov 14, 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). DUE TO COMPLAINTS OF A REFRACTIVE MIS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER ODYSSEY LENS OF A DIFFERENT POWER, IOL MODEL INFORMATION WAS NOT PROVIDED. THERE WERE NO COMPLICATIONS DURING THE LENS EXCHANGE PROCEDURE. 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 23563087 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED, TORIC II INTRAOCULAR LENS (IOL) WAS IMPLANTED DURING CATARACT SURGERY IN THE LEFT EYE. POSTOPERATIVELY, THE PATIENT EXPERIENCED INTOLERABLE GLARE AND POOR-QUALITY VISION THAT COULD NOT BE CORRECTED BEYOND 20/40, EVEN WITH GLASSES. THESE SYMPTOMS AFFECTED THE PATIENT¿S ABILITY TO PERFORM DAILY ACTIVITIES, INCLUDING DRIVING AT NIGHT. ATTEMPTS TO ADAPT, SUCH AS WALKING AROUND THE CLINIC WITH TRIAL FRAMES, DID NOT RESOLVE THE ISSUE, AND THE PATIENT REPORTED A DECREASE IN VISUAL ACUITY. A SLIT-LAMP EXAMINATION IDENTIFIED VISUALLY SIGNIFICANT LENS OPACITY AS A PRIMARY FACTOR CONTRIBUTING TO THE REDUCED VISUAL ACUITY. IT WAS INDICATED THAT THE PATIENT HAS NATURALLY OCCURRING ASTIGMATISM AND WANTED TO HAVE REDUCED DEPENDENCE ON GLASSES. THEREFORE, ELECTED TO PROCEED WITH THE LENS EXPLANTATION. THE ORIGINAL LENS WAS EXPLANTED AND REPLACED WITH COMPETITOR'S TORIC LENS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO PATIENT INJURY WAS REPORTED DURING THE EXPLANTATION, AND NO ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 23441041 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED, TORIC II INTRAOCULAR LENS (IOL) WAS IMPLANTED DURING CATARACT EXTRACTION SURGERY WITHOUT COMPLICATIONS. FOLLOWING THE PROCEDURE, THE PATIENT REPORTED PERSISTENT DRY EYE SYMPTOMS THAT DID NOT RESPOND TO EYE DROPS OR OINTMENTS, AS WELL AS ONGOING HEADACHES AND PAIN DURING READING. IT WAS CONFIRMED THAT THE EYE DROPS AND OINTMENTS WERE PART OF THE STANDARD OF CARE. SUBSEQUENTLY, THE PATIENT SOUGHT A SECOND OPINION AND OPTED TO UNDERGO BILATERAL INTRAOCULAR LENS EXCHANGE FOR BOTH LENSES. IT IS UNKNOWN IF THE PATIENT HAD ANY DEBILITATING OR PRE-EXISTING CONDITIONS. THE PATIENT OUTCOME POST EXPLANT IS UNKNOWN. NO FURTHER INFORMATION PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Dry Eye(s); Eye Pain; Headache

  MAUDE report 23439809 ↗
• InjuryJun 19, 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'S READING VISION GOES IN AND OUT. THE SHADOWS AND HALOS WERE REALLY BAD AT NIGHT. THE ISSUE WAS IDENTIFIED DURING POST -OP VISIT. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 22290579 ↗
• InjuryMay 13, 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 PATIENT REPORTED VISION NOT BEING AS SHARP, HARD TIME ADJUSTING/FOCUSING, AND -0.36D MYOPIC MISS. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 19.0 DIOPTER IOL. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22012566 ↗