PURESEE IOL DEN00V (REF DEN00VU235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS PURESEE SIMPLICITY 23.5D · Class 3 · Implant
All models of PURESEE IOL (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474806528), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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