TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500255)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC ODYSSEY TOR II SMPCY 25.5D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474811461), received between Feb 13, 2025 and Jan 30, 2026 — classified as 3 injuries.
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 Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE LENS WAS LATER EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V LENS (24.5 DIOPTER) DUE TO A MECHANICAL COMPLICATION. THE PATIENT OUTCOME WAS GOOD. BEST CORRECTED VISUAL ACUITY (BCVA) PREOPERATIVELY WAS 20/70-1, AND POSTOPERATIVELY WAS 20/60-1 WITH PINHOLE (PH) 20/40. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223069 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. POST-OPERATIVELY, THE PATIENT HAD GLARE AND HALOS AT NIGHT DESPITE HAVING GOOD VISION, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIU150 25.0 IOL. REPORTEDLY THERE WAS NO PATIENT ISSUES. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 23088958 ↗InjuryFeb 13, 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 RIGHT EYE. AS THE PATIENT HAD A HYPEROPIC MISS; +1.66 D. PATIENT WAS UNABLE TO READ IN HER DAY TO DAY BASIS (BOOK, LABELS, SIGNS, ETC.) BECAUSE THE HYPEROPIC MISS. THE LENS WAS REPLACED WITH A DRT LENS WITH 26.0 DIOPTER IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. AFTER NEW LENS THE PATIENT'S VISION WAS SLIGHTLY BLURRY BUT LATER IT IMPROVED AND IS DOING GOOD.
Patient problems: Visual Impairment
MAUDE report 21379421 ↗
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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