TECNIS IOL DXR00V (REF DXR00VU140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474761674), received between Mar 29, 2023 and Oct 17, 2025 — 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.

• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE DOCTOR SAID HER PATIENT IS UNHAPPY WITH THE OUTCOME OF HER IOL AND HAD IT EXPLANTED BY A DIFFERENT SURGEON IN THE AREA. SHE DOES NOT KNOW THE DATE OF THE EXPLANT. PRIOR TO THE EXPLANT, THE PATIENT CALLED JOHNSON AND JOHNSON TO REPORT HER DISSATISFACTION. AT THAT TIME THE EVENT WAS NOT REPORTABLE. THE PATIENT REPORTED THAT AFTER HER CATARACT SURGERY SHE EXPERIENCED VISUAL DISTURBANCES AND DISCOMFORT. SHE DESCRIBED EXPERIENCING LIGHT SENSITIVITY, BOUNCING LIGHTS ON THE RIGHT SIDE NEAR LIGHT SOURCES, CONCENTRIC RINGS OF THE LENS WHILE DRIVING, SHADOWS, DOUBLE VISION RESEMBLING A DUPLICATE IMAGE IN HER RIGHT EYE, AND AN INABILITY TO SEE CLEARLY OUT OF HER RIGHT EYE. SHE ALSO NOTED A 4.5 DIOPTER DIFFERENCE BETWEEN HER EYES, DIFFICULTY DRIVING AT NIGHT, AND EYE TWITCHING IN DAYLIGHT. DESPITE BEING INFORMED THAT HER VISION WOULD IMPROVE, SHE STATED THAT IT IS WORSE THAN EXPECTED. THE PATIENT HAS CONSULTED HER EYE DOCTOR FIVE TIMES AND WAS INFORMED BY HER CURRENT SURGEON THAT AN EXCHANGE TO A MONOFOCAL LENS WOULD BE NECESSARY. HOWEVER, HER CURRE

  Patient problems: Discomfort; Foreign Body Sensation in Eye; Visual Disturbances; Visual Impairment

  MAUDE report 23327778 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO GLARE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZA9003, DIFFERENT DIOPTER, 13.5). THERE WAS NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING FINE POST-OPERATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16640810 ↗