TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 14.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474811249), received between Apr 3, 2025 and Feb 13, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 Problem1
- Break1
- Crack1
Patient problems
- Eye Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Break; Crack
IT WAS REPORTED THAT THE INJECTOR ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) SPLIT UPON INSERTION OF THE LENS RESULTING IN THE IOL BEING FRACTURED. THE FRACTURED ON THE LENS OCCURRED PRIOR TO INSERTING INTO THE EYE. CONSEQUENTLY, THE IOL WAS REMOVED WITH NO HARM TO THE PATIENT. JOHNSON AND JOHNSON PERFORMED FOLLOW-UP TO GET ADDITIONAL DETAILS, BUT A RESPONSE HAS NOT BEEN RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24340178 ↗InjuryApr 3, 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 OPERATIVE EYE. DUE TO UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 16.5 DIOPTER IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 21767715 ↗
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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