TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 14.0D 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
- 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 05050474811232), received between Sep 9, 2025 and Jun 8, 2026 — 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 Vision3
- Visual Impairment2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Scratched Material
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS FOUND TO BE SCRATCHED AFTER IMPLANTING IT. THE SCRATCHED LENS WAS CUT OUT AND A NEW IOL OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25438637 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. THE PATIENT IS EXTREMELY UNHAPPY, BLURRY VISION, AND HAS HYPEROPIC SURPRISE. INITIALLY, THE DOCTOR PLANNED ON EXPLANTING THE LENS ON (B)(6) 2026. HOWEVER, THE IOL WAS TOO DIFFICULT TO REMOVE. THE DOCTOR REPOSITIONED IT INSTEAD AND USED SUTURES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24677990 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER THE MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT EXPERIENCED BLURRED AND HAZY VISION WITH THE MULTIFOCAL LENS AND WANTED AN IOL EXCHANGE. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY CHANGED FROM 20/25 PRE-OPERATIVELY TO 20/40 POST-OPERATIVELY. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY SURGERY AND ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIU150 14.0 DIOPTER). DURING THE PROCEDURE, AN UNPLANNED INCISION ENLARGEMENT OCCURRED; HOWEVER, NO UNPLANNED SUTURES OR VITRECTOMY WERE REQUIRED AND THERE WERE NO DELAYS IN THE PROCEDURE. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S STATUS FOLLOWING THE SURGERY IS CURRENTLY UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23575829 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ODYSSEY TORIC INTRAOCULAR LENS (IOL) EXCHANGE DUE TO DISSATISFACTION WITH NEAR/INTERMEDIATE VISION AND FELT THAT SHE COULD NOT READ WELL DESPITE A QUALITATIVE OUTCOME. THE ORIGINAL LENS WAS REPLACED WITH NON-J&J LENS. THE AFFECTED EYE WAS THE LEFT EYE (OS). PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/40 AND 20/50. POST-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY 1 DAY POST-OP IOL EXCHANGE WAS 20/30-2, J1. POST-EXCHANGE, THE PATIENT¿S UNCORRECTED AND BEST-CORRECTED VISUAL ACUITY IMPROVED FROM J2 PRE-EXCHANGE TO J1 ON POST-OP DAY 1. NO PATIENT INJURY OR DEBILITATING CONDITION. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE NOT REQUIRED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 22999865 ↗
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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