PURESEE IOL DEN00V (REF DEN00VU150)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS PURESEE SIMPLICITY 15.0D · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474806351), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Opacification1
Patient problems
- Eye Injury1
- 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.
InjuryApr 3, 2023Break; Material Opacification; Break; Material Opacification
IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE RIGHT EYE, IT WAS DETERMINED TO BE "DEFECTIVE" AND WAS THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE. PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/40. PRE-OPERATIVE BEST CORRECTED DISTANCE VA WAS 20/30. NO INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY WAS REQUIRED AND THERE WAS NO PATIENT INJURY. THERE WAS NO DELAY IN PROCEDURE. NO MEDICAL ATTENTION OR MEDICATION WAS REQUIRED. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. THIS EVENT WAS REPORTED IN A MASKED CLINICAL STUDY.
Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 16665389 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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