TECNIS ODYSSEY IOLRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 49 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 389
- Deaths reported
- 0
- Injuries reported
- 265
- Recalls
- 0
We found 49 models of TECNIS ODYSSEY IOL by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 389 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2023 and Sep 29, 2026 — classified as 265 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Break” (54 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 IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem248
- Break54
- Scratched Material50
- Device Difficult to Setup or Prepare16
- Mechanical Jam10
- Material Split, Cut or Torn9
- Ejection Problem8
- Appropriate Device Problem Term/Code Not Available5
Patient problems
- No Clinical Signs, Symptoms or Conditions124
- Visual Disturbances97
- Blurred Vision86
- Halo85
- Visual Impairment50
- Eye Injury36
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available17
- Flashers12
TECNIS ODYSSEY IOL models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular37 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular30 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular29 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular29 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular24 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular20 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular18 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular18 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular16 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular16 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular13 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular12 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular11 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular9 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular9 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular8 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular5 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular4 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular4 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular4 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular4 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular3 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular3 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular2 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular2 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular2 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular2 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular2 reports
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
- TECNIS ODYSSEY IOL DRN00VLens, multifocal intraocular1 report
Recent TECNIS ODYSSEY IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50926896 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50926574 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50926511 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905084 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 50902755 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 50902712 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision; Halo; Pain; Visual Disturbances
MAUDE report 50885505 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830440 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Disturbances
MAUDE report 50830168 ↗MalfunctionSep 18, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827429 ↗InjurySep 10, 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 right eye. The patient experienced symptoms however, the details were not provided. The IOL was explanted and replaced with a non-Johnson and Johnson lens model LAL +19.5 diopter. The patient¿s pre-operative best corrected visual acuity (BSCVA) was reported as 20/40, post-operative 20/20. Reportedly, the directions for use were followed. There were no complications such as a vitrectomy, incision enlargement, sutures or delay in the procedure. There was no medication outside the standard of care. The patient has fully recovered. No further information was provided.
Patient problems: Eye Injury
MAUDE report 50718084 ↗MalfunctionSep 8, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680136 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo; Visual Disturbances
MAUDE report 50676585 ↗MalfunctionAug 27, 2026Scratched Material
It was reported that a preloaded multifocal intraocular lens (IOL) was observed to have a dark marking near the edge of the lens. Despite the observed marking, the lens was successfully implanted, and no patient concerns were reported. The lens remains implanted. Additional information received indicated that the issue was not related to use error, as no resistance was encountered and no excessive force was applied during lens delivery. No patient injury was reported, and no unplanned medical or surgical interventions, such as vitrectomy, incision enlargement, or sutures were required. The physician indicated that the device did not cause or contribute to the event. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479074 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a lens exchange was performed in the right eye of a patient. The implanted preloaded multifocal intraocular lens (IOL) was explanted due to the patient's complaint of halos while driving at night, which significantly interfered with daily activities. The lens was exchanged with a DEN00V +20.5D IOL. The patient's pre-operative visual acuity was reported as 20/25, and the post-operative visual acuity was reported as 20/40 at one day post-operatively. No patient injury was reported. No medical or surgical interventions associated with the event were reported, and no future interventions were planned. The patient was reported to be doing well post-operatively following the lens exchange. The explanted lens was discarded and, therefore, is not available for evaluation. No further information was provided.
Patient problems: Halo; Visual Impairment
MAUDE report 50437548 ↗
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 TORIC II IOL106 models · 285 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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