TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500230)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 23.0D CYL1.50 · Class 3 · Implant
All models of TECNIS ODYSSEY TORIC II IOL (106)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474811416), received between Apr 30, 2025 and Apr 16, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Material Split, Cut or Torn1
Patient problems
- Visual Disturbances2
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Adverse 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 EXPERIENCED VISION ISSUES, WHICH LED TO A LENS ROTATION ON (B)(6) 2026; HOWEVER, THE ISSUE PERSISTED. ON (B)(6) 2026, AN IOL EXCHANGE WAS PERFORMED AND A DRT150 23.5D IOL WAS IMPLANTED. THERE WERE NO SUTURES DURING THE EXPLANT PROCEDURE AND THE PATIENT TOLERATED THE EXCHANGE PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 24902603 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WILL BE REMOVED AS THE PATIENT COMPLAINED OF POOR VISION. THIS ISSUE WAS IDENTIFIED AFTER THE LENS WAS IMPLANTED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026, INDICATING THAT THE PATIENT HAD AN EXPLANT PERFORMED, AS THE DEVICE WAS RECEIVED FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 24731569 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT¿S COMPLAINT OF DYSPHOTOPSIA. THE REPLACEMENT LENS WAS A JOHNSON & JOHNSON DIB00, 23.0 DIOPTER LENS. NO MEDICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Disturbances
MAUDE report 24464386 ↗InjuryMay 23, 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 WAS INTOLERANT OF MULTI-FOCAL SIDE-EFFECTS. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ LENS IN A SECONDARY PROCEDURE. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 22079496 ↗MalfunctionApr 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE AS THE FOCAL POINT OF THE OPTIC OF THE LENS WAS TORN. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939755 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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