PURESEE IOL DEN00V (REF DEN00VU145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS PURESEE SIMPLICITY 14.5D · Class 3 · Implant
All models of PURESEE IOL (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474806344), received between Aug 4, 2026 and Aug 11, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Contamination1
Patient problems
- Blurred Vision1
- Inflammation1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Contamination
Patient problems: Inflammation
MAUDE report 50202248 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implanted extended depth of focus (EDOF) intraocular lens (IOL) in the left eye (OS) was associated with inadequate near and intermediate vision despite excellent distance visual outcomes. The reported visual difficulties impacted the patient's reading and work activities. The physician reported dissatisfaction with the lens performance and indicated that the lens had been explanted. The patient did not experience a loss of ¿2 lines of best spectacle-corrected visual acuity (BSCVA) and was not overcorrected or under corrected. Pre-operative refraction was reported as -3.00 -0.50 x 178 with a pre-operative BSCVA of 20/30+2. Post-operative uncorrected visual acuity (UCVA) was reported as distance visual acuity (DVA) 20/20 and near visual acuity (NVA) J8. Post-operative refraction was +0.25 -0.25 x 053, with a post-operative BSCVA of 20/20 and an intended target refraction of +0.04. Post-operative findings reportedly suggested a questionable hyperopic target or landing.The explanted lens was exchanged for a non-Johnson & Johnson trifocal intraocular lens (IOL) with a power of +15.0 diopters (D) and add powers of +1.75 D and +3.50 D. No additional unplanned or m
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 50136056 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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