TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500215)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 21.5D 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
- 8
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474811386), received between Jun 13, 2024 and Mar 6, 2026 — classified as 6 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Scratched Material3
- Physical Resistance/Sticking1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision2
- Halo2
- Discomfort1
- Eye Injury1
- Visual Disturbances1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2026Scratched Material; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE AND SUBSEQUENTLY EXPLANTED DURING THE SAME SURGERY DUE TO A SCRATCHED LENS AND HAPTICS THAT WERE STUCK TOGETHER, AS SHOWN IN THE ATTACHED PHOTOS. ADDITIONAL INFORMATION CONFIRMED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP LENS OF THE SAME MODEL AND DIOPTER. THE PATIENT IS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24536304 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) IN THE LEFT EYE WAS EXCHANGED FOR AN UNKNOWN REASON. THE REPLACEMENT LENS WAS ANOTHER JOHNSON & JOHNSON MODEL OF THE SAME TYPE BUT WITH A DIFFERENT DIOPTER (DRT150 +22.5). NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS, SUCH AS INCISION ENLARGEMENT OR SUTURING, WERE PERFORMED. PREOPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) WAS 20/50-1, AND POSTOPERATIVE UNCORRECTED VISUAL ACUITY IMPROVED TO 20/25-2. THE PATIENT¿S CONDITION WAS REPORTED AS IMPROVING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 24214631 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO THE PATIENT EXPERIENCING HALOS AND BLURRED VISION IN THE LEFT EYE. THE ORIGINAL LENS WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL; DIFFERENT MODEL AND DIOPTER (DRN00V, 20.5 D). POST-OPERATIVELY, THE PATIENT¿S SYMPTOMS IMPROVED, AND VISUAL ACUITY INCREASED FROM 20/30 PRE-OPERATIVELY TO 20/20 POST-OPERATIVELY. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NONE ARE ANTICIPATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Halo
MAUDE report 23351515 ↗InjuryJun 20, 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 THE PATIENT'S RIGHT EYE DUE TO RESIDUAL HYPEROPIA. THE ISSUE WAS IDENTIFIED DURING THE POST-OP EXAMINATION. THE BEST CORRECTED VISUAL ACUITY PRE-OP WAS 20/20, AND THE BEST CORRECTED VISUAL ACUITY POST-OP WAS 20/20. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDIAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 22302037 ↗InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED AND REPLACED WITH AN LAL+ LENS BECAUSE THE PATIENT COMPLAINED AT EVERY ADDITIONAL POST-OPERATIVE VISIT ABOUT THE QUALITY OF VISION, LACK OF RANGE OF FOCUS, HALOS, AND GLARE WHEN DRIVING AT NIGHT. REPORTEDLY THE DEVICE DID NOT WORK AS INTENDED AND THE PATIENT WAS UNABLE TO PERFORM ONE OR MORE DAILY ACTIVITIES POST-SURGERY. THE EXPLANT WAS SUCCESSFUL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Discomfort; Halo; Visual Disturbances
MAUDE report 21590631 ↗InjuryFeb 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 EYE. DUE TO COMPLAINTS OF AN ARTIFACT IN HIS PERIPHERAL VISION AND STRUGGLING WITH INTERMEDIATE VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 23.0 DIOPTER IOL. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS DOING GOOD. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Vitreous Floaters
MAUDE report 21465266 ↗MalfunctionOct 25, 2024Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material
IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS NOTICED WITH A SCRATCH, THE CAUSE IS TO BE DETERMINED BUT POTENTIALLY DUE TO SIMPLICITY INJECTOR AND LENS BEING FORCED THROUGH, AND THEN IOL WAS EXPLANTED. THE DOCTOR THEN IMPLANTED THE SAME MODEL AND DIOPTER SIZE IOL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539733 ↗InjuryJun 13, 2024Scratched Material; Scratched Material
IT WAS REPORTED AFTER IMPLANTING THE DRT150 MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE. DAMAGE ON THE IOL WAS NOTED, DAMAGE WAS STATED TO BE A SCRATCH. THE SURGEON EXPLANTED THE DAMAGED LENS AND IMPLANTED ANOTHER IOL WITH THE SAME MODEL AND POWER. IT WAS CLARIFIED THE PATIENT WAS INITIALLY BROUGHT TO POST-OP AND ABOUT ONE (1) HOUR LATER WAS TAKEN BACK INTO THE OPERATING ROOM TO EXPLANT THE IOL AND IMPLANT THE 2ND IOL. THE SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS OR INJURIES TO THE PATIENT. PHOTO OF THE IOL IS AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525951 ↗
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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