PURESEE IOL DEN00V (REF DEN00VU240)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS PURESEE SIMPLICITY 24.0D · 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 05050474806535), received between Feb 21, 2023 and Feb 21, 2023 — classified as 1 malfunction.
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
- Device Difficult to Setup or Prepare1
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.
MalfunctionFeb 21, 2023Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
IT WAS REPORTED THAT IT WAS DIFFICULT TO GET THE INTRAOCULAR LENS (IOL) EJECTED FROM THE INJECTOR AND AFTER THAT THE LENS WAS SCRATCHED. FURTHER CLARIFICATION NOTED AS INITIAL RESISTANCE WHEN ADVANCING THE IOL WITH THE INSERTER THAT WENT AWAY. LIKE THE INITIAL RESISTANCE WENT AWAY. THIS WAS OBSERVED DURING IMPLANTATION/APPLICATION. FOLLOWING IMPLANTATION, DOCTOR CONFIRMED THAT THE OPTIC WAS IN FACT CRACKED INSTEAD OF SCRATCHED. THAT REQUIRED IOL REMOVAL AND REPLACEMENT DURING THE SAME PROCEDURE. BEST CORRECTED VISUAL ACUITY (BCVA) 20/30. NO OTHER ADVERSE EVENTS. THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16410112 ↗
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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