TECNIS IOL DXR00V (REF DXR00VU165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474761728), received between Jun 14, 2023 and Jun 29, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 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 LEFT EYE. THE PATIENT WAS BOTHERED BY HALOS AT NIGHT. THEIR DAILY ACTIVITIES WERE NOT IMPACTED BY THE SYMPTOMS. THE CUSTOMER REPORTED THAT THEY FOLLOWED THE DIRECTIONS FOR USE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY AND NO DELAY IN PROCEDURE. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS NEEDED. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE WAS 20/50 J1 AND POST-OPERATIVE 20/20 J1. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JNJ LENS NAME PURESEE 16.5 DIOPTER, MODEL DEN00V. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 25660433 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO HALOS AND FLOATERS THAT WERE CAUSING HEADACHES. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIB00, SAME DIOPTER). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT POST-OPERATIVE STATUS IS UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Headache; Vitreous Floaters

  MAUDE report 17836778 ↗
• MalfunctionJun 14, 2023Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  IT WAS REPORTED REGARDING THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL). THE PLUNGER WENT OVER THE IOL, THE HAPTIC BECAME LOOSE AND ULTIMATELY BROKE OFF MAKING THE LENS UNABLE TO DELIVER. THERE WAS NO PATIENT CONTACT WITH THE IOL AS THE PLUNGER WENT OVER THE LENS. THE IOL WAS WASTED. HOWEVER, THE CUSTOMER USED A BACKUP LENS TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17123138 ↗