TECNIS IOL DXR00V (REF DXR00VU200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474761797), received between May 2, 2023 and Jun 1, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Fold” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 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 PATIENTS RIGHT EYE. AFTER THE IMPLANT THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON MODEL, RX LAL 19.5. THE PATIENT WAS NOT HARMED THEIR FINAL OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25352752 ↗
• InjuryJun 1, 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 PATIENTS LEFT EYE. AFTER THE IMPLANT THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON MODEL, RX LAL 18.5. THE PATIENT WAS NOT HARMED THEIR FINAL OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25352742 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE IN A SECONDARY SURGERY DUE TO THE PATIENT BEING UNABLE TO TOLERATE THE LENS WITH SYMPTOMS OF BLURRED VISION, POSITIVE DYSPHOTOPSIA, HALOS, AND GLARE. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THERE WAS NO REPORTED PATIENT HARM. THE PATIENT¿S SYMPTOMS RESOLVED WITH THE INSERTION OF ANOTHER JOHNSON AND JOHNSON IOL (DIB00). THE PRE-OPERATIVE REFRACTION WAS RECORDED AS 0.00 +0.25 AT 0.05, WITH A PRE-OPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) OF 20/25, WHICH WAS REDUCED TO 20/40 WITH GLARE. THE POST-OPERATIVE REFRACTION WAS NOTED AS -1.00 +1.25 AT 0.05, WITH A POST-OPERATIVE BSCVA OF 20/25. THE INTENDED TARGET REFRACTION WAS PLANO. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 23829075 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DXR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS FIFTEEN (15) YEARS AGO HE HAD LASIK PERFORMED. IN 2024 HE HAD CATARACT SURGERY, IT WAS NOTED AT THAT TIME HE HAD SOME SWELLING OF CORNEA AND A LOW CELL COUNT IN THE CORNEAL LENS. PATIENT WAS PRESCRIBED MEDICATION (PREDNISONE), THAT HE HAS BEEN TAKING FOR EIGHT (08) MONTHS. HE HAS NOT BEEN ABLE TO SEE CORRECTLY OUT OF LEFT EYE, VISION IS BLURRED. HIS DOCTOR PERFORMED A PHOTOREFRACTIVE KERATECTOMY (PRK) AND TOLD HIM IF HE EXCHANGED THE LENS, HE WOULD ALSO NEED TO REPLACE THE CORNEA. AFTER THE PRK PROCEDURE, THE PATIENT EXPERIENCED LEAKING, SO HE SAW A CORNEA SPECIALIST WHO INFORMED HIM THAT THE EYE BAND AID PLACED AFTER SURGERY HAD BEEN REMOVED TOO SOON. CORNEA SPECIALIST ALSO TOLD HIM THAT HE DIDN'T NEED SURGERY, BUT INSTEAD THAT THE OPENING AND CLOSING OF HIS EYE WAS NOT ALLOWING HIS EYE TO HEAL. THE CORNEA SPECIALIST PLACED ANOTHER EYE BAND AID ON HIM AND PRESCRIBED HIM ANTIBIOTICS FOR TWO (02) MONTHS. SHE INDICATED HE HAD A CORNEA HOLE OR CORNEAL EROSION AND REFERRED HIM BACK TO HIS ORIGINAL DOCTOR. SINCE PLACING THE BAND AID ON, THE PATIENT STATED HIS EYE FEELS MORE

  Patient problems: Blurred Vision; Corneal Abrasion; Corneal Edema; Wound Dehiscence

  MAUDE report 22122962 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT LEFT EYE AS THE PATIENT COMPLAINED OF HALOS AND DECREASED VISUAL ACUITY. A NON-JOHNSON AND JOHNSON LENS OF 19.5 DIOPTER WAS USED AS A REPLACEMENT. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO PATIENT INJURY REPORTED. THE PATIENT IS DOING FINE POST EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 18598134 ↗
• InjuryMay 2, 2023Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE RIGHT EYE AND REPLACED DURING THE SAME PROCEDURE DUE TO THE LEAD HAPTIC COMING OUT AND CAUSING A TEAR IN THE CAPSULE BAG. THE ISSUE WAS OBSERVED AFTER INSERTION. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZMA00 (3-PIECE LENS), DIFFERENT DIOPTER, 19.0). THERE WAS NO PATIENT INJURY. A VITRECTOMY AND SUTURES WERE REQUIRED. NO FURTHER INFORMATION WAS REQUIRED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16857531 ↗