TECNIS ODYSSEY TORIC II IOLRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 106 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 285
- Deaths reported
- 0
- Injuries reported
- 210
- Recalls
- 0
We found 106 models of TECNIS ODYSSEY TORIC II IOL by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 285 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2024 and Sep 30, 2026 — classified as 210 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Break” (43 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TECNIS ODYSSEY TORIC II IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem192
- Break43
- Scratched Material21
- Device Difficult to Setup or Prepare13
- Crack8
- Mechanical Jam7
- Ejection Problem5
- Application Program Problem: Dose Calculation Error4
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- Blurred Vision79
- Visual Disturbances72
- Halo61
- Visual Impairment53
- Eye Injury22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Flashers9
TECNIS ODYSSEY TORIC II IOL models
106 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular19 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular11 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular11 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular11 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular10 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular9 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular8 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular8 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular6 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular6 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular6 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular5 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular5 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular5 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular5 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular5 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular5 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular4 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular3 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular3 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular3 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular3 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular3 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular3 reports
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular3 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular2 reports
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT150Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT225Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT300Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular1 report
- TECNIS ODYSSEY TORIC II IOL DRT375Lens, multifocal intraocular1 report
Recent TECNIS ODYSSEY TORIC II IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo; Visual Disturbances
MAUDE report 50952802 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo; Visual Disturbances
MAUDE report 50926705 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50926579 ↗MalfunctionSep 25, 2026Break; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904555 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo; Visual Disturbances
MAUDE report 50903343 ↗MalfunctionSep 21, 2026Unstable
Patient problems: Visual Impairment
MAUDE report 50845495 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822390 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo
MAUDE report 50782318 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following implantation of a preloaded multifocal Toric intraocular lens (IOL) in the patient's right eye, the patient experienced halos at night and difficulty with both distance and near vision. The patient reported that halos remained present; however, her primary concern was poor near and distance vision. The patient indicated that she relied primarily on her left eye, which retained the natural lens and utilized a contact lens, for functional vision.The patient reported discussing her symptoms with the implanting physician and was advised to allow additional time for adaptation because the lens was reported to be well positioned and centered. The patient was prescribed glasses; however, no new prescription was provided, and the patient stated that her near vision was worse while wearing the glasses. The patient reported using Restasis® eye drops for dry eye management.The patient stated that she remained able to perform activities of daily living by relying on her left eye and utilizing multiple pairs of glasses and sunglasses. The patient reported that no medications outside the standard of care were prescribed and that she planned to obtain a second opini
Patient problems: Blurred Vision; Dry Eye(s); Halo; Retinal Detachment; Vitreous Floaters
MAUDE report 50735061 ↗MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679877 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the preloaded Johnson and Johnson (JnJ) Intraocular lens (IOL) was implanted into the patient¿s left eye. The patient experienced symptoms which details were not provided. The symptoms were reported as debilitating due to the effect it had on the patient¿s driving. The IOL was explanted and replaced with another Johnson and Johnson lens model DEN00V 21.0 diopter. There was no capsule tear, vitrectomy, incision enlargement or sutures. The patient¿s pre-operative uncorrected and best corrected visual acuity was reported as 20/25 -2 and post-operative. No further information was provided.
Patient problems: Eye Injury
MAUDE report 50436682 ↗MalfunctionAug 19, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333946 ↗MalfunctionAug 17, 2026Break; Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288711 ↗InjuryAug 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the preloaded Johnson and Johnson (JnJ) Intraocular lens (IOL) was implanted into the patient's right eye. The customer reported that there was a mistake in the lens power chosen for the patient. There was nothing wrong with the lens. The patient was unhappy with their vision. There were no complications such as a vitrectomy, incision enlargement or sutures. The IOL was explanted and replaced with another JnJ lens model DET150 20.5 diopter. The patient is doing well. No further information is available.
Patient problems: Visual Impairment
MAUDE report 50256402 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent bilateral implantation of preloaded multifocal intraocular lenses (IOLs), models DXW150 and DRT225. Following implantation, the patient experienced intolerance to the multifocal intraocular lenses. As a result, both lenses were explanted during secondary surgical procedures.The replacement lens for the patient's right eye was a different model with the same diopter power, DET300U285 (SN (b)(6)). The replacement lens for the patient's left eye was a different model with a 0.5 diopter difference, DET150U285 (SN (b)(6)). The patient reported difficulty reading medication labels, viewing her phone, and reading expiration dates on food packaging. No incision enlargement, sutures, vitrectomy, or procedure delays were reported. The patient's outcome status was reported as unknown.The patient's preoperative refraction prior to the original surgery was +2.75 -0.75 x 076 in the right eye and +2.25 -0.50 x 040 in the left eye, with a target postoperative refraction of plano in both eyes. The postoperative refraction was reported as +1.00 -1.50 x 100 in the right eye and plano -0.75 x 150 in the left eye. The Directions for Use (DFU) were followed, and
Patient problems: Visual Disturbances
MAUDE report 50203038 ↗
Other Johnson & Johnson Surgical Vision, Inc. products
- TECNIS IOL1,344 models · 10,702 reports · 3 recalls
- FS DISPOSABLE INTERFACE2 models · 4,239 reports
- TECNIS SIMPLICITY112 models · 2,730 reports · 1 recall
- SENSAR IOL112 models · 1,213 reports
- TECNIS CL IOL42 models · 558 reports
- TECNIS ODYSSEY IOL49 models · 389 reports
- UNFOLDER EMERALD2 models · 258 reports
- LAMINAR13 models · 203 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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