PURESEE IOLRecalls & reported problems across all models
Johnson & Johnson Surgical Vision, Inc. · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 21 models of PURESEE IOL by Johnson & Johnson Surgical Vision, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2023 and Sep 30, 2026 — classified as 20 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 PURESEE IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Break3
- Appropriate Device Problem Term/Code Not Available2
- Contamination1
- Device Difficult to Setup or Prepare1
- Material Opacification1
- Operating System Becomes Nonfunctional1
- Scratched Material1
Patient problems
- Visual Disturbances8
- Blurred Vision7
- Visual Impairment7
- Eye Injury5
- No Clinical Signs, Symptoms or Conditions4
- Halo3
- Flashers2
- Inflammation2
PURESEE IOL models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PURESEE IOL DEN00Vintraocular lens2 reports
- PURESEE IOL DEN00Vintraocular lens2 reports
- PURESEE IOL DET150intraocular lens2 reports
- PURESEE IOL DEN00Vintraocular lens1 report
- PURESEE IOL DEN00Vintraocular lens1 report
- PURESEE IOL DEN00VExtended depth of focus intraocular lens1 report
- PURESEE IOL DEN00Vintraocular lens1 report
- PURESEE IOL DEN00VExtended depth of focus intraocular lens1 report
- PURESEE IOL DEN00Vintraocular lens1 report
- PURESEE IOL DEN00VExtended depth of focus intraocular lens1 report
- PURESEE IOL DEN00Vintraocular lens1 report
- PURESEE IOL DET150intraocular lens1 report
- PURESEE IOL DET150LENS, INTRAOCULAR, TORIC OPTICS1 report
- PURESEE IOL DET150intraocular lens1 report
- PURESEE IOL DET150LENS, INTRAOCULAR, TORIC OPTICS1 report
- PURESEE IOL DET150LENS, INTRAOCULAR, TORIC OPTICS1 report
- PURESEE IOL DET150intraocular lens1 report
- PURESEE IOL DET225Extended depth of focus intraocular lens1 report
- PURESEE IOL DET225intraocular lens1 report
- PURESEE IOL DET225intraocular lens1 report
- PURESEE IOL DET225Extended depth of focus intraocular lens1 report
Recent PURESEE 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: Eye Injury
MAUDE report 50949496 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 50938412 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a preloaded extended depth of focus (EDOF) toric intraocular lens (IOL) implanted in the patient's right eye was explanted and replaced with a preloaded multifocal intraocular lens (IOL) of a different model and power (+17.5D). The lens exchange was performed to change the implanted lens from model DET225 (+17.0D, cylinder 2.25D) to a multifocal lens. No unplanned surgical intervention or procedural complication was reported in association with the lens exchange. It is unknown whether the patient experienced limitations in daily activities, a loss of two or more lines of best spectacle-corrected visual acuity (BSCVA), overcorrection, under correction, or any adverse outcome following the procedure. The patient's current clinical status and outcome are unknown. No further information was provided.
Patient problems: Eye Injury
MAUDE report 50927055 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50904145 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Flashers; Halo; Visual Disturbances
MAUDE report 50903080 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Impairment
MAUDE report 50809412 ↗InjurySep 17, 2026Appropriate Device Problem Term/Code Not Available
It was reported that a preloaded extended depth of focus (EDOF) toric intraocular lens (IOL) was implanted in the patient's left eye (OS) during cataract surgery. Following implantation, the patient experienced hazy and blurry vision. Preoperative refraction was reported as +0.75 -1.50 x014 with a best spectacle-corrected visual acuity (BSCVA) of 20/60. Postoperative uncorrected visual acuity (UCVA) was reported as 20/30 distance vision with cloudy/blurry vision and J6 near vision. Postoperative refraction was reported as +0.25, postoperative BSCVA was 20/25, and the intended target refraction was -0.03.Clinical evaluation reportedly revealed optic atrophy in the left eye (OS) with depressed visual fields. Optical coherence tomography (OCT) findings were reported as normal, and magnetic resonance imaging (MRI) was ordered to evaluate a potential neuro-ophthalmic etiology. Subsequent follow-up information indicated that the MRI findings were normal. The physician also reported observing a prominent lathe pattern on the anterior surface of the implanted lens.The patient was reportedly dissatisfied with the visual outcome and continued to experience blurry vision following surgery. Th
Patient problems: Blurred Vision
MAUDE report 50805295 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision; Corneal Edema; Flashers; Headache; Visual Disturbances; Visual Impairment
MAUDE report 50781841 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Eye Injury
MAUDE report 50676876 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Impairment
MAUDE report 50676577 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Disturbances
MAUDE report 50507913 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that, following implantation of a preloaded multifocal intraocular lens (IOL) in the patient's left eye, the patient experienced a refractive surprise. The patient had a history of prior photorefractive keratectomy (PRK). As a result, the lens was explanted during a secondary surgical procedure and replaced with a lens of the same model with a 1.5 diopter difference (DEN00V220, Serial Number: (b)(6)). The explanted lens was discarded.Follow-up information indicated that no capsule tear, unplanned vitrectomy, or sutures were required during the procedure. No medications outside the standard of care were administered. The preoperative refraction was reported as -1.00 -0.75 × 040 with a visual acuity of 20/15, and the postoperative refraction was -0.75 -1.00 × 070 with a visual acuity of 20/15. No further information was provided.
Patient problems: Visual Impairment
MAUDE report 50479486 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo; Visual Disturbances
MAUDE report 50421502 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Halo; Visual Disturbances
MAUDE report 50421487 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411481 ↗
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
- TECNIS ODYSSEY TORIC II IOL106 models · 285 reports
- UNFOLDER EMERALD2 models · 258 reports
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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