SENSAR IOLRecalls & 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
- Adverse event reports
- 1,213
- Deaths reported
- 0
- Injuries reported
- 423
- Recalls
- 0
We found 112 models of SENSAR IOL by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 1,213 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2016 and Sep 30, 2026 — classified as 423 injuries, 790 malfunctions.
The most frequently reported specific device problem is “Break” (609 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 SENSAR IOL problems
Device problems
- Break609
- Adverse Event Without Identified Device or Use Problem196
- Material Fragmentation105
- Scratched Material56
- Use of Device Problem42
- Appropriate Device Problem Term/Code Not Available34
- Device Dislodged or Dislocated32
- Contamination23
Patient problems
- No Clinical Signs, Symptoms or Conditions640
- No Code Available163
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available115
- Capsular Bag Tear70
- No Consequences Or Impact To Patient65
- No Known Impact Or Consequence To Patient62
- No Patient Involvement42
- Eye Injury39
SENSAR IOL models
112 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- SENSAR IOL AR40eintraocular lens57 reports
- SENSAR IOL AR40eintraocular lens49 reports
- SENSAR IOL AR40eintraocular lens47 reports
- SENSAR IOL AR40eintraocular lens45 reports
- SENSAR IOL AR40eintraocular lens39 reports
- SENSAR IOL AR40eintraocular lens38 reports
- SENSAR IOL AR40eintraocular lens37 reports
- SENSAR IOL AR40eintraocular lens35 reports
- SENSAR IOL AR40eintraocular lens35 reports
- SENSAR IOL AR40eintraocular lens31 reports
- SENSAR IOL AR40Eintraocular lens29 reports
- SENSAR IOL AR40eintraocular lens29 reports
- SENSAR IOL AR40Eintraocular lens25 reports
- SENSAR IOL AAB00intraocular lens25 reports
- SENSAR IOL AR40eintraocular lens22 reports
- SENSAR IOL AAB00intraocular lens21 reports
- SENSAR IOL AR40Mintraocular lens20 reports
- SENSAR IOL AR40eintraocular lens20 reports
- SENSAR IOL AR40eintraocular lens19 reports
- SENSAR IOL AAB00intraocular lens19 reports
- SENSAR IOL AAB00intraocular lens18 reports
- SENSAR IOL AR40Mintraocular lens17 reports
- SENSAR IOL AAB00intraocular lens17 reports
- SENSAR IOL AR40eintraocular lens16 reports
- SENSAR IOL AAB00intraocular lens16 reports
- SENSAR IOL AR40Eintraocular lens15 reports
- SENSAR IOL AR40Eintraocular lens15 reports
- SENSAR IOL AR40Eintraocular lens14 reports
- SENSAR IOL AAB00intraocular lens14 reports
- SENSAR IOL AAB00intraocular lens13 reports
- SENSAR IOL AAB00intraocular lens13 reports
- SENSAR IOL AAB00intraocular lens13 reports
- SENSAR IOL AR40Mintraocular lens12 reports
- SENSAR IOL AR40eintraocular lens12 reports
- SENSAR IOL AR40eintraocular lens12 reports
- SENSAR IOL AR40Mintraocular lens12 reports
- SENSAR IOL AAB00intraocular lens12 reports
- SENSAR IOL AR40eintraocular lens11 reports
- SENSAR IOL AR40eintraocular lens11 reports
- SENSAR IOL AAB00intraocular lens11 reports
- SENSAR IOL AR40Mintraocular lens10 reports
- SENSAR IOL AR40eintraocular lens10 reports
- SENSAR IOL AR40eintraocular lens10 reports
- SENSAR IOL AR40eintraocular lens10 reports
- SENSAR IOL AR40Mintraocular lens9 reports
- SENSAR IOL AR40eintraocular lens9 reports
- SENSAR IOL AAB00intraocular lens9 reports
- SENSAR IOL AR40Mintraocular lens8 reports
- SENSAR IOL AR40eintraocular lens8 reports
- SENSAR IOL AR40eintraocular lens8 reports
- SENSAR IOL AR40eintraocular lens8 reports
- SENSAR IOL AR40Eintraocular lens8 reports
- SENSAR IOL AR40Eintraocular lens7 reports
- SENSAR IOL AR40eintraocular lens7 reports
- SENSAR IOL AR40eintraocular lens7 reports
- SENSAR IOL AR40eintraocular lens7 reports
- SENSAR IOL AR40Mintraocular lens7 reports
- SENSAR IOL AAB00intraocular lens7 reports
- SENSAR IOL AR40eintraocular lens6 reports
- SENSAR IOL AR40Eintraocular lens6 reports
- SENSAR IOL AAB00intraocular lens6 reports
- SENSAR IOL AAB00intraocular lens6 reports
- SENSAR IOL AAB00intraocular lens6 reports
- SENSAR IOL AR40Mintraocular lens5 reports
- SENSAR IOL AR40eintraocular lens5 reports
- SENSAR IOL AR40eintraocular lens5 reports
- SENSAR IOL AR40eintraocular lens5 reports
- SENSAR IOL AR40Mintraocular lens5 reports
- SENSAR IOL AAB00intraocular lens5 reports
- SENSAR IOL AR40eintraocular lens4 reports
- SENSAR IOL AR40Mintraocular lens4 reports
- SENSAR IOL AR40Mintraocular lens4 reports
- SENSAR IOL AAB00intraocular lens4 reports
- SENSAR IOL AAB00intraocular lens4 reports
- SENSAR IOL AR40Mintraocular lens3 reports
- SENSAR IOL AR40Mintraocular lens3 reports
- SENSAR IOL AR40eintraocular lens3 reports
- SENSAR IOL AR40Mintraocular lens3 reports
- SENSAR IOL AAB00intraocular lens3 reports
- SENSAR IOL AAB00intraocular lens3 reports
- SENSAR IOL AAB00intraocular lens3 reports
- SENSAR IOL AR40Mintraocular lens2 reports
- SENSAR IOL AR40Mintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40eintraocular lens2 reports
- SENSAR IOL AR40Mintraocular lens2 reports
- SENSAR IOL AR40Mintraocular lens2 reports
- SENSAR IOL AAB00intraocular lens2 reports
- SENSAR IOL AAB00intraocular lens2 reports
- SENSAR IOL AAB00intraocular lens2 reports
- SENSAR IOL AAB00intraocular lens2 reports
- SENSAR IOL AR40eintraocular lens1 report
- SENSAR IOL AR40eintraocular lens1 report
- SENSAR IOL AR40eintraocular lens1 report
Recent SENSAR IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that, after implantation of the non-preloaded monofocal intraocular lens (IOL) using smooth McPherson forceps, a "bite" was noted near the haptic. The lens was removed and replaced during the same procedure with a lens of the same model and diopter power. No unplanned incision enlargement was reported. Information regarding unplanned vitrectomy, suturing, procedural delay, and patient outcome was unavailable. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949430 ↗MalfunctionSep 25, 2026Material Fragmentation
It was reported that a non-preloaded monofocal intraocular lens (IOL) was inserted into the patient's left eye and, during the implantation procedure, both haptics broke off inside the eye. The IOL was subsequently removed and replaced with another lens of the same model and diopter power. No unplanned vitrectomy or additional medical intervention outside the standard of care was reported. It is unknown whether unplanned sutures were required or whether the procedure was delayed. The patient outcome was unknown. It was noted that the lens was discarded. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892878 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860829 ↗InjurySep 22, 2026Difficult to Insert
It was reported that a three-piece non-preloaded monofocal intraocular lens (IOL) was opened on the back table and the haptics were observed to be bent/kinked prior to use. A backup IOL of the same model was used; however, it was implanted and subsequently removed due to positioning in the eye. The doctor then decided to perform a vitrectomy. The procedure was successfully completed using another IOL of the same model. An Emerald cartridge was used. No patient harm was reported. The ophthalmic viscosurgical device (OVD) and balanced salt solution (BSS) used were unknown. However, it was reported that the IOL was allowed to rest in the cartridge for a period of time before being handed to the doctor. No further information was provided.
Patient problems: Eye Injury
MAUDE report 50849614 ↗MalfunctionSep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830898 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830728 ↗MalfunctionSep 18, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829496 ↗MalfunctionSep 18, 2026Break; Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826402 ↗MalfunctionSep 17, 2026Break
It was reported that the standalone Intraocular Lens (IOL) was defective and could not be implanted. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805604 ↗MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762796 ↗MalfunctionAug 25, 2026Break; Difficult to Insert
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50439076 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50383130 ↗MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50244329 ↗InjuryAug 11, 2026Break
It was reported that the non-preloaded monofocal intraocular lens (IOL) was implanted in the patient's operative eye; however, following implantation, it was noted that the lens had a broken haptic. An AR40 12.0D lens was ordered, and a lens exchange was planned. Through follow up we learned that the lens was explanted on (b)(6) 2026. However, the surgeon decided to postpone implantation of a replacement lens, as the eye was not in a suitable condition to receive a new IOL at that time. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211697 ↗MalfunctionAug 7, 2026Break
It was reported that the back haptic of a non-preloaded monofocal intraocular lens (IOL) was damaged during injection. The specific nature of the haptic damage was not identified. There was patient contact . The complaint device was discarded. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184318 ↗
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
- 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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