PURESEE IOL DEN00V (REF DEN00VU190)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS PURESEE SIMPLICITY 19.0D · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474806436), received between Apr 5, 2023 and Apr 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Operating System Becomes Nonfunctional” (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 16, 2026.
Most reported problems
Device problems
- Operating System Becomes Nonfunctional1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2023Operating System Becomes Nonfunctional; Scratched Material; Operating System Becomes Nonfunctional; Scratched Material
IT WAS REPORTED UPON IMPLANTATION OF THE DCB00 INTRAOCULAR LENS (IOL), THE OPTIC WAS SCRATCHED. DOCTOR HAD DIFFICULTY WITH INSERTER/PLUNGER AND STATED SCRATCH ON OPTIC WAS DUE TO THE INSERTER. IOL WAS REMOVED AND A BACK-UP IOL WAS INSERTED WITHOUT ISSUE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. THERE WAS ALSO NO PROCEDURAL DELAY, NO MEDICAL ATTENTION, AND NO MEDICATION WERE REQUIRED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. SUBJECT VISION IS 20/25-2. SLIT LAMP WAS NORMAL AND NO SUBJECT COMPLAINTS WERE REPORTED. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS FULLY INSERTED WHEN SCRATCH ON OPTIC WAS OBSERVED. THE REPLACEMENT IOL WAS THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16687060 ↗
Other Extended depth of focus intraocular lens devices
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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