PURESEE IOL DEN00V (REF DEN00VU215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474806481), received between Aug 11, 2023 and Jul 29, 2026 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the preloaded Johnson and Johnson (JnJ) Intraocular lens (IOL) was implanted into the patient¿s right eye. The patient experienced blurry vision and dysphotopsia. Reportedly, the device did not cause or contribute to the event. The IOL was explanted and replaced with the same model but different diopter, model DEN00V 22.0 diopter. The patient¿s outcome is unknown. No further information is available.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50072421 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE CLINICAL STUDY INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT MENTIONED SEVERE CLOUDINESS AT THE ONE WEEK FIRST FOLLOW-UP VISIT. THERE WERE 0.5 CELLS NOTED IN THE ANTERIOR CHAMBER. THE SITE HAD PERFORMED OPTICAL COHERENCE TOMOGRAPHY (OCT) AND CONFIRMED THAT THE MACULA WAS NORMAL. WHEN THE PATIENT RETURNED ON AN UNSCHEDULED VISIT ON (B)(6) 2022, THE VISUAL ACUITY WAS 20/25 AND NO CELLS WERE SEEN IN THE ANTERIOR CHAMBER. THE PATIENT STILL COMPLAINED OF VISUAL SYMPTOMS. THE SITE PLANNED TO BRING THE PATIENT BACK FOR ADDITIONAL ASSESSMENTS IN TWO WEEKS TO DETERMINE IF POSSIBLE SURGICAL INTERVENTION WAS NECESSARY. THE PATIENT¿S LEFT EYE (SECOND EYE) CATARACT SURGERY HAD BEEN POSTPONED. THROUGH FOLLOW UP IT WAS LEARNED THAT THE VISUAL SYMPTOMS OBSERVED WERE MODERATE CLOUDY/HAZY/FILMY/FOGGY VISION. THE ONSET OF SYMPTOMS WERE OBSERVED ON (B)(6) 2022. THE TARGET REFRACTIVE VALUE PRE-OPERATIVE (PRE-INITIAL IMPLANT) WAS -0.09. FINAL REFRACTIVE VALUES POST-OPERATIVE (POST-INITIAL IMPLANT) WERE SPHERE: -00.75; CYLINDER: 00.75; AXIS: 125 AT ONE MONTH VISIT (B)(6) 2023, AND SPHERE: -0.50; CYLINDER: 0.50; AXIS: 145 AT AN UNSCHEDULED VISIT (B)(6) 2

  Patient problems: Blurred Vision; Inflammation; Visual Impairment

  MAUDE report 17508232 ↗