TECNIS SIMPLICITYRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 112 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TECNIS SIMPLICITY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,730
- Deaths reported
- 0
- Injuries reported
- 575
- Recalls
- 1
We found 112 models of TECNIS SIMPLICITY by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 2,730 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2020 and Sep 30, 2026 — classified as 575 injuries, 2,155 malfunctions.
The most frequently reported specific device problem is “Break” (1,057 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
TECNIS SIMPLICITY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 19, 2026Open, Classified
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Z-1634-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported TECNIS SIMPLICITY problems
Device problems
- Break1,057
- Adverse Event Without Identified Device or Use Problem426
- Scratched Material327
- Crack256
- Ejection Problem160
- Mechanical Jam144
- Material Fragmentation135
- Inaccurate Delivery109
Patient problems
- No Clinical Signs, Symptoms or Conditions2,156
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available138
- Capsular Bag Tear131
- Blurred Vision95
- Visual Disturbances92
- Eye Injury89
- Visual Impairment77
- Corneal Edema19
TECNIS SIMPLICITY models
112 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- TECNIS SIMPLICITY DIB00intraocular lens1 recall81 reports
- TECNIS SIMPLICITY DCB00intraocular lens120 reports
- TECNIS SIMPLICITY DCB00intraocular lens114 reports
- TECNIS SIMPLICITY DCB00intraocular lens99 reports
- TECNIS SIMPLICITY DCB00intraocular lens96 reports
- TECNIS SIMPLICITY DCB00intraocular lens95 reports
- TECNIS SIMPLICITY DCB00intraocular lens95 reports
- TECNIS SIMPLICITY DCB00intraocular lens93 reports
- TECNIS SIMPLICITY DIB00intraocular lens93 reports
- TECNIS SIMPLICITY DCB00intraocular lens89 reports
- TECNIS SIMPLICITY DIB00intraocular lens79 reports
- TECNIS SIMPLICITY DIB00intraocular lens76 reports
- TECNIS SIMPLICITY DCB00intraocular lens75 reports
- TECNIS SIMPLICITY DCB00intraocular lens70 reports
- TECNIS SIMPLICITY DIB00intraocular lens70 reports
- TECNIS SIMPLICITY DIB00intraocular lens70 reports
- TECNIS SIMPLICITY DCB00intraocular lens65 reports
- TECNIS SIMPLICITY DIB00intraocular lens63 reports
- TECNIS SIMPLICITY DCB00intraocular lens60 reports
- TECNIS SIMPLICITY DIB00intraocular lens60 reports
- TECNIS SIMPLICITY DIB00intraocular lens58 reports
- TECNIS SIMPLICITY DIB00intraocular lens55 reports
- TECNIS SIMPLICITY DCB00intraocular lens50 reports
- TECNIS SIMPLICITY DCB00intraocular lens42 reports
- TECNIS SIMPLICITY DCB00intraocular lens42 reports
- TECNIS SIMPLICITY DIB00intraocular lens41 reports
- TECNIS SIMPLICITY DCB00intraocular lens33 reports
- TECNIS SIMPLICITY DIB00intraocular lens32 reports
- TECNIS SIMPLICITY DIB00intraocular lens30 reports
- TECNIS SIMPLICITY DIB00intraocular lens30 reports
- TECNIS SIMPLICITY DIB00intraocular lens29 reports
- TECNIS SIMPLICITY DIB00intraocular lens26 reports
- TECNIS SIMPLICITY DCB00intraocular lens24 reports
- TECNIS SIMPLICITY DCB00intraocular lens23 reports
- TECNIS SIMPLICITY DCB00intraocular lens23 reports
- TECNIS SIMPLICITY DCB00intraocular lens22 reports
- TECNIS SIMPLICITY DIB00intraocular lens20 reports
- TECNIS SIMPLICITY DIB00intraocular lens19 reports
- TECNIS SIMPLICITY DIB00intraocular lens18 reports
- TECNIS SIMPLICITY DCB00intraocular lens17 reports
- TECNIS SIMPLICITY DCB00intraocular lens17 reports
- TECNIS SIMPLICITY DIB00intraocular lens17 reports
- TECNIS SIMPLICITY DIB00intraocular lens17 reports
- TECNIS SIMPLICITY DCB00intraocular lens16 reports
- TECNIS SIMPLICITY DCB00intraocular lens15 reports
- TECNIS SIMPLICITY DIB00intraocular lens15 reports
- TECNIS SIMPLICITY DCB00intraocular lens14 reports
- TECNIS SIMPLICITY DIB00intraocular lens14 reports
- TECNIS SIMPLICITY DCB00intraocular lens13 reports
- TECNIS SIMPLICITY DIB00intraocular lens13 reports
- TECNIS SIMPLICITY DCB00intraocular lens12 reports
- TECNIS SIMPLICITY DCB00intraocular lens12 reports
- TECNIS SIMPLICITY DIB00intraocular lens11 reports
- TECNIS SIMPLICITY DCB00intraocular lens10 reports
- TECNIS SIMPLICITY DIB00intraocular lens10 reports
- TECNIS SIMPLICITY DCB00intraocular lens9 reports
- TECNIS SIMPLICITY DCB00intraocular lens9 reports
- TECNIS SIMPLICITY DCB00intraocular lens9 reports
- TECNIS SIMPLICITY DCB00intraocular lens8 reports
- TECNIS SIMPLICITY DCB00intraocular lens8 reports
- TECNIS SIMPLICITY DCB00intraocular lens8 reports
- TECNIS SIMPLICITY DCB00intraocular lens7 reports
- TECNIS SIMPLICITY DIB00intraocular lens7 reports
- TECNIS SIMPLICITY DIB00intraocular lens7 reports
- TECNIS SIMPLICITY DIB00intraocular lens7 reports
- TECNIS SIMPLICITY DCB00intraocular lens6 reports
- TECNIS SIMPLICITY DCB00intraocular lens6 reports
- TECNIS SIMPLICITY DCB00intraocular lens6 reports
- TECNIS SIMPLICITY DCB00intraocular lens5 reports
- TECNIS SIMPLICITY DCB00intraocular lens5 reports
- TECNIS SIMPLICITY DIB00intraocular lens5 reports
- TECNIS SIMPLICITY DIB00intraocular lens5 reports
- TECNIS SIMPLICITY DIB00intraocular lens5 reports
- TECNIS SIMPLICITY DIB00intraocular lens5 reports
- TECNIS SIMPLICITY DCB00intraocular lens4 reports
- TECNIS SIMPLICITY DCB00intraocular lens4 reports
- TECNIS SIMPLICITY DCB00intraocular lens4 reports
- TECNIS SIMPLICITY DCB00intraocular lens4 reports
- TECNIS SIMPLICITY DCB00intraocular lens4 reports
- TECNIS SIMPLICITY DCB00intraocular lens4 reports
- TECNIS SIMPLICITY DIB00intraocular lens4 reports
- TECNIS SIMPLICITY DIB00intraocular lens4 reports
- TECNIS SIMPLICITY DIB00intraocular lens4 reports
- TECNIS SIMPLICITY DIB00intraocular lens4 reports
- TECNIS SIMPLICITY DIB00intraocular lens4 reports
- TECNIS SIMPLICITY DCB00intraocular lens3 reports
- TECNIS SIMPLICITY DCB00intraocular lens3 reports
- TECNIS SIMPLICITY DCB00intraocular lens3 reports
- TECNIS SIMPLICITY DCB00intraocular lens3 reports
- TECNIS SIMPLICITY DIB00intraocular lens3 reports
- TECNIS SIMPLICITY DIB00intraocular lens3 reports
- TECNIS SIMPLICITY DIB00intraocular lens3 reports
- TECNIS SIMPLICITY DIB00intraocular lens3 reports
- TECNIS SIMPLICITY DIB00intraocular lens3 reports
- TECNIS SIMPLICITY DIB00intraocular lens3 reports
- TECNIS SIMPLICITY DCB00intraocular lens2 reports
- TECNIS SIMPLICITY DCB00intraocular lens2 reports
- TECNIS SIMPLICITY DCB00intraocular lens2 reports
- TECNIS SIMPLICITY DCB00intraocular lens2 reports
- TECNIS SIMPLICITY DIB00intraocular lens2 reports
Recent TECNIS SIMPLICITY 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
It was reported that the preloaded monofocal intraocular lens (IOL) was explanted due to unknown reason. Additional information received indicated that the lens was discarded by operating room staff. No additional information was provided.
Patient problems: Eye Injury
MAUDE report 50949039 ↗InjurySep 30, 2026Crack
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury
MAUDE report 50948539 ↗InjurySep 25, 2026Mechanical Jam
It was reported that a preloaded monofocal intraocular lens (IOL) would not fire/deploy from the chamber. The cartridge tip touched the patient's right eye. Unplanned sutures were required to protect the eye after attempting to insert the lens. An incision enlargement and unplanned vitrectomy were not required. Another Johnson & Johnson lens (same model and diopter) was implanted as a replacement. Patient status was reported as unknown. The product is not available to return. No other information is available.
Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 50900947 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a preloaded monofocal intraocular lens (IOL) was implanted and subsequently explanted and replaced with a 3-piece intraocular lens (IOL) (model AR40E, 15.5 diopter). The reason for the explant and replacement was not reported. Patient outcome information was unavailable. No further information was provided.
Patient problems: Eye Injury
MAUDE report 50899688 ↗MalfunctionSep 25, 2026Break
It was reported that, during implantation of a preloaded monofocal intraocular lens (IOL) in the patient's left eye, the leading haptic protruded from the injector/cartridge while the surgeon was advancing the lens for implantation. The issue was identified prior to insertion into the operative eye, during lens advancement, and no resistance was encountered. The affected IOL was not implanted, and the procedure was successfully completed using another lens of the same model and diopter. No patient injury was reported, no unplanned surgical interventions were required, and no medications outside the standard of care were prescribed. The patient was reported to have a normal prognosis and outcome. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893037 ↗MalfunctionSep 24, 2026Break
Patient problems: Prolapse
MAUDE report 50892479 ↗MalfunctionSep 24, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892420 ↗MalfunctionSep 23, 2026Scratched Material; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874888 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831501 ↗MalfunctionSep 18, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830239 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Disturbances
MAUDE report 50829688 ↗MalfunctionSep 18, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828362 ↗MalfunctionSep 18, 2026Scratched Material
It was reported that, during handling and prior to insertion, the preloaded monofocal intraocular lens (IOL) was scratched during the loading process. There was no patient contact with the device. The IOL was discarded. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821161 ↗MalfunctionSep 18, 2026Ejection Problem
It was reported that the trailing haptic of the preloaded monofocal intraocular lens (IOL) was stuck in the cartridge. The physician successfully loosened the haptic and implanted the lens. No additional surgical maneuvers beyond the standard surgical technique were required to deliver or position the IOL. Provisc Ophthalmic Viscosurgical Device (OVD) was used to fill the cartridge prior to loading the lens according to the Directions for Use (DFU). No patient injury was reported. The current patient outcome was reported as standard. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820435 ↗MalfunctionSep 17, 2026Break
It was reported that the preloaded, monofocal, Intraocular Lens (IOL) was faulty. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797178 ↗
Other Johnson & Johnson Surgical Vision, Inc. products
- TECNIS IOL1,344 models · 10,702 reports · 3 recalls
- FS DISPOSABLE INTERFACE2 models · 4,239 reports
- SENSAR IOL112 models · 1,213 reports
- TECNIS CL IOL42 models · 558 reports
- TECNIS ODYSSEY IOL49 models · 389 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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