TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500135)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 13.5D 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474811225), received between Sep 6, 2024 and Nov 26, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Scratched Material1
Patient problems
- Blurred Vision1
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT VISIBLE MARKS OR SCRATCHES WERE FOUND ON THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) AFTER THE LENS WAS FULLY INSERTED IN THE OPERATIVE EYE. NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THERE WAS NO MEDICAL ATTENTION OR MEDICATION PRESCRIBED OUTSIDE THE STANDARD OF CARE. IT WAS REPORTED THAT THE PATIENT IS FULLY RECOVERED. DIRECTIONS FOR USE WERE FOLLOWED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657776 ↗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 DISSATISFACTION WITH NEAR VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCU150 17.0 IOL. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION DURING THE EXPLANT PROCEDURE. PATIENT'S PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 23641032 ↗InjuryMay 8, 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. THE IOL WAS EXPLANTED BECAUSE THE PATIENT WAS EXPERIENCING MYOPIA SURPRISE, NIGHT TIME DISTURBANCES WERE MORE THAN EXPECTED. THE ISSUE WAS NOTICED DURING A POST-OPERATIVE EXAMINATION. THE PATIENT¿S PRE-OPERATIVE VISUAL ACUITY WAS REPORTED AS PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) 20/25. THEIR POST-OPERATIVE BSCVA WAS NOT REPORTED. THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME MODEL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAY IN PROCEDURE. THE PATIENT DID NOT SEEK MEDICAL ATTENTION OR REQUIRE MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT IS HEALTHY AND BOTH THE SURGEON AND PATIENT ARE HAPPY WITH THE REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 21989268 ↗InjurySep 6, 2024Adverse 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. THE REASON FOR THE EXPLANT IS THE PATIENT COMPLAINED OF VISUAL DISCOMFORT, GLARE, AND HALOS. THE REPLACEMENT IOL IS A BAUSCH & LOMB SOFPORT - ADVANCED OPTICS ASPHERIC LENS, POWER 16.5 AND MODEL PC: LI61AO. THERE WAS NO INJURY SUCH AS A CAPSULE TEAR. REPORTEDLY, INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR MEDICAL WERE NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 20164615 ↗
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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