TECNIS IOL DXR00V (REF DXR00VU210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474761810), received between Mar 22, 2023 and Jun 12, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS (IOL) DID NOT PERFORM AS EXPECTED. THE EVENT WAS OBSERVED DURING IMPLANTATION/APPLICATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487844 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DXR00V, WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. POSTOPERATIVELY, THE PATIENT EXPERIENCED POOR BUT NOT DEBILITATING VISUAL QUALITY. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON¿JOHNSON & JOHNSON LENS. THERE WERE NO CAPSULE TEARS, UNPLANNED VITRECTOMY, SUTURES, OR MEDICATIONS BEYOND THE STANDARD OF CARE REQUIRED. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 24640642 ↗
• InjuryAug 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 INTENSE GLARE, STARBURSTS, AND HALOS AROUND LIGHTS BOTH INDOORS AND OUTDOORS. THE PATIENT IS UNABLE TO TOLERATE OUTDOOR ENVIRONMENTS, KEEPS ALL BLINDS CLOSED INDOORS, AND STATES THAT LIGHTS ARE CAUSING HEADACHES AND POSSIBLE SEIZURE ACTIVITY. THE SYMPTOMS ARE DESCRIBED AS SIGNIFICANTLY AFFECTING HER ABILITY TO CARRY OUT DAILY ACTIVITIES. THE IOL DEVICE REMAINS IMPLANTED, AND THE PATIENT HAS INDICATED THAT SHE MAY CONSIDER EXPLANTATION AND WILL PROVIDE NOTIFICATION IF THIS OCCURS. NO FURTHER INFORMATION REGARDING THE EVENT IS AVAILABLE.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 22881549 ↗
• MalfunctionMar 12, 2025Break; Break

  ACCOUNT REPORTED THERE WAS NO RESISTANCE AND HAPTIC "NOT RIGHT" INDENT IN THE CENTER OPTIC. THERE WAS NO PATIENT CONTACT AND THE ISSUE WAS NOTICED DURING HANDLING /PRIOR TO INSERTION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590057 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE PATIENT WAS UNABLE TO DRIVE AT NIGHT WITH THE SYMFONY LENS. THE ISSUE WAS FIRST IDENTIFIED AFTER IMPLANTATION. IT WAS INDICATED THAT PATIENT'S DAILY ACTIVITIES SIGNIFICANTLY AFFECTED. NO VITRECTOMY, NO SUTURES REQUIRED, UNKNOWN IF INCISION WAS ENLARGED, IF MEDICATION WAS PRESCRIBED AND IF THERE WAS A DELAY IN PROCEDURE. REPLACEMENT IOL WAS A NON JOHNSON AND JOHNSON IOL. THE PATIENT OUTCOME STATUS IS UNKNOWN; HOWEVER, IT WAS CONFIRMED THAT THERE WAS NO POST-OP PATIENT INJURY. DOCTOR DID NOT KEEP IOL AFTER REMOVAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19368300 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW MONTHS AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE, THE PATIENT EXPERIENCED DYSPHOTOPSIA AND HALOS AND COULD NOT ADJUST. THE PATIENT WILL HAVE THE LENS REMOVED. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. FURTHER INFORMATION WAS PROVIDED THAT THE IOL WAS EXPLANTED AND ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCB00 WAS IMPLANTED AS A REPLACEMENT. THE LENS THAT WAS REMOVED WAS NOT SAVED BY THE OPERATING ROOM (OR). NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19235674 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT'S RIGHT EYE. IT WAS NOTED THAT THE PATIENT WAS NOT SEEING DISTANCE AND EXPERIENCES GLARE AT NIGHT, AND ABOUT THE LAST 3 WEEKS THINGS HAVE SHIFTED. THE IMPLANTED SUSPECT IOL WAS EXPLANTED/EXCHANGED. IT WAS STATED THAT VISION PRE-OP WAS 20/25 CORRECTED, POST-OP 20/30 (BEFORE EXCHANGE), THE REPLACEMENT IOL IDENTIFIERS WERE NOT PROVIDED. NO VITRECTOMY, NO SUTURES, NO DELAY IN PROCEDURE, NO MEDICATION PRESCRIBED. IT IS UNKNOWN IF THERE WAS AN INCISION ENLARGEMENT. DIRECTIONS FOR USE (DFU) FOLLOWED. PATIENT POST-EXPLANT STATUS UNKNOWN. NO OTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19173957 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT A 3-WEEKS POST OP PATIENT WITH A SYMFONY OPTIBLUE INTRAOCULAR LENS (IOL) WAS EXPERIENCING SIGNIFICANT STARBURSTS AT NIGHT TO THE POINT WHERE SHE DOES NOT WANT TO DRIVE. THE PATIENT WAS ESSENTIALLY PLANO AND WITH AN AUTO REFRACTOR, SHE WAS -0.75 AS EXPECTED. THE OCT (OPTICAL COHERENCE TOMOGRAPHY) IS CLEAR, TOMOGRAPHY SHOWS LITTLE CYLINDER AND NO SIGNS OF DRY EYE. THE PATIENT WAS GIVEN SOME TEARS AND EVEN THOUGH PUPIL WAS NORMAL SIZED, THE PATIENT WAS GIVEN SOME VUITY EYE DROPS AND WAS ASKED TO GIVE IT FOR ANOTHER 3 WEEKS. THE PATIENT¿S NEAR OR INTERMEDIATE VISION WAS OK BUT A LITTLE LESS THAN EXPECTED WHICH COULD BE THE REASON FOR THE REFRACTION BEING SLIGHTLY PLUS. THE DOCTOR WAS HOPING TO AVOID AN EXCHANGE. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DOCTOR HAD REMOVED THE SYMFONY LENS FROM THE PATIENT AND IT WAS REPLACED WITH A COMPETITOR LENS. THERE WERE NO COMPLICATIONS WITH THE EXCHANGE INCLUDING NO VITRECTOMY OR SUTURE. THEY DO NOT HAVE THE LENS AND THE LENS IS NOT BEING RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Visual Impairment

  MAUDE report 18149861 ↗
• MalfunctionMar 22, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) BROKE AS THE DOCTOR INSERTED IT INTO THE EYE. THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL, A SYMFONY LENS. REPORTEDLY, THERE WAS NO CAPSULE TEAR, VITRECTOMY AND NO SUTURES. THE SUSPECT PRODUCT WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593085 ↗