TECNIS IOL DXR00V (REF DXR00VU195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474761780), received between Jan 13, 2023 and Feb 23, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DYSPHOTOPSIA SYMPTOMS AFTER THE IMPLANTATION OF A PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE VISUAL SYMPTOMS WERE DESCRIBED AS HALOS AND GLARE. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY. THERE WERE NO REPORTED PATIENT HARM. THE DEVICE WAS DISCARDED AND NOT AVAILABLE TO RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24415283 ↗
• InjuryNov 12, 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 DEXTER (RIGHT EYE). PATIENT REPORTED COMPLAINTS OF INTOLERABLE GLARE, STARBURSTS, HALOS, AND NIGHT TIME VISION. PATIENT SYMPTOMS PERSISTED DESPITE MULTIPLE POST-OPERATIVE VISITS AND ATTEMPTS TO OPTIMIZE THE OCULAR SURFACE, AND REFRACTIVE ERROR, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCB00 19.5 IOL. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS MINIMAL INCISION ENLARGEMENT HOWEVER, THERE WERE NO COMPLICATIONS, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS GREAT PROGNOSIS AND VISUAL ACUITY POST-OPERATIVE WEEK 1 WAS 20/25 SANS CORRECTION (SC). THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 23538336 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH A MULTIFOCAL SYMPHONY INTRAOCULAR LENS (IOL) EXHIBITED SYMPTOMS OF DYSPHOTOPSIA. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL IOL IN SECONDARY SURGICAL PROCEDURE WITHOUT ANY COMPLICATIONS. NO ADDITIONAL MEDICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WERE REQUIRED DURING THE PROCEDURE. THE PATIENT¿S OUTCOME WAS REPORTED TO BE FINE. NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: Visual Disturbances

  MAUDE report 22689799 ↗
• InjuryFeb 18, 2025Adverse 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 THE PATIENT EXPERIENCING SPIDER WEBS AND EXCESSIVE GLARE. THE IOL WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON LENS (MODEL DRN00V, 19.5 DIOPTER). THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Vitreous Floaters

  MAUDE report 21402603 ↗
• InjuryJan 31, 2025Adverse 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'S RIGHT EYE. THE PATIENT HAS REPORTED DISSATISFACTION WITH THE NEAR VISION CAPABILITIES OF THE LENS, WHICH HAS SIGNIFICANTLY IMPACTED HIS ABILITY TO PERFORM WORK-RELATED TASKS AS AN ACCOUNTANT (PATIENT IS DISAPPOINTED ON NEAR POINT). A REPLACEMENT LENS OF DIFFERENT MODEL DRN00V, BUT OF THE SAME DIOPTER AS THE ORIGINAL LENS WAS IMPLANTED. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT IS VERY HAPPY WITH THE EXCHANGE. NO CAPSULE TEAR, NO UNPLANNED VITRECTOMY, NO SUTURES AND NO MEDICATIONS OUTSIDE THE REGULAR STANDARD OF CARE WAS REQUIRED. THE ORIGINAL LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 21284651 ↗
• MalfunctionDec 27, 2024Scratched Material; Physical Resistance/Sticking; Scratched Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS HAD TO BE CUT OUT DUE TO COMPLETE MESH ON THE LENS FROM THE TRAILING HAPTIC STICKING. IT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH ANOTHER JOHNSON & JOHNSON IOL. NO INJURY OR FURTHER INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028735 ↗
• InjuryNov 19, 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 THE PATIENT'S LEFT EYE. THE REASON FOR EXPLANT WAS INDICATED THAT THE PATIENT UNHAPPY WITH QUALITY OF VISION, HALOS AND GLARE. ALTHOUGH, INITIALLY INDICATED THAT THE PATIENT WAS HAVING GLARE SO YELLOW TINTED LENS WAS PUT IN, BUT THE DOCTOR LATER CLARIFIED THAT "THE GLARE WAS NOT THERE BEFORE THE ORIGINAL LENS WAS IMPLANTED". VISUAL ISSUES OCCURRED 1 DAY POST-IMPLANT. THE REPLACEMENT LENS WAS A NON-JOHNSON & JOHNSON LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE. IT WAS CONFIRMED THAT THE PATIENT WAS FINE POST-OP. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20729222 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MULTIFOCAL LENS WAS EXPLANTED BECAUSE THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. THE LENS WAS REMOVED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH AN IOL FROM ANOTHER COMPANY. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT EXPERIENCED UNCLEAR AND BLURRY VISION AND WAS DISSATISFIED WITH THE LENS SELECTION. THE PATIENT ALSO DEVELOPED POSTERIOR CAPSULAR OPACIFICATION (PCO) AFTER THE SURGERY, WHICH WAS SUBSEQUENTLY TREATED WITH A YAG PROCEDURE. THE PATIENT IS JUST FINE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 20409649 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS EXCHANGE WAS DUE TO REFRACTIVE SURPRISE AND THE HISTORY OF MYOPIC LASIK. IT WAS REPLACED IN A SECONDARY SURGICAL PROCEDURE WITH ANOTHER LENS (MODEL DXR00V). THE PATIENT¿S OUTCOME IS UNKNOWN. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. THE LENS WAS DESTROYED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 19767097 ↗
• InjuryJun 26, 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 A PATIENT'S RIGHT EYE DUE TO DYSPHOTOPSIA. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME WAS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19620997 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AFTER THE PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENSES (IOLS) WERE IMPLANTED INTO THE RIGHT AND LEFT EYE, THE PATIENT HAS BEEN EXPERIENCING HALOS, STARBURSTS, AND GLARE. THOUGH FOLLOW-UP, IT WAS LEARNED THAT SOON AFTER THE LENSES WERE IMPLANTED, THE PATIENT BEGAN TO EXPERIENCE SEVERE STARBURST, HUGE HALOS, GLARE, AND SPIDERWEBS AT NIGHT AND IS NO LONGER ABLE TO DRIVE AT NIGHT DUE TO THESE ISSUES. THE PATIENT IS ABLE TO SEE GREAT DURING THE DAY. THE PATIENT REPORTED HAVING "A SORT OF MENTAL BREAKDOWN" BECAUSE OF THE VISUAL ISSUES. THE PATIENT IS GOING TO GET A SECOND OPINION WITH ANOTHER SURGEON TO SEE IF THE LENSES CAN BE EXCHANGED FOR MONOFOCAL LENSES. NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED. THERE ARE NO PLANNED INTERVENTIONS. THE LENSES REMAIN IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR THE LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE EVENT FOR THE RIGHT EYE.

  Patient problems: Distress; Flashers; Halo; Visual Disturbances

  MAUDE report 19244347 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF GLARE AND HALO; REPLACEMENT LENS INFORMATION IS UNKNOWN. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN. PATIENT'S OUTCOME POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17455878 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DXR00V 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OPERATIVE EYE. IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF DYSPHOTOPSIAS, SPIDERWEBBING, AND HALOES/STARBURST WHEN SEEING LIGHTS AT NIGHT WHILE DRIVING. PATIENT DOES NOT FEEL COMFORTABLE DRIVING AT NIGHT. PRE-OPERATIVE VISION: 20/25 AND POST-OPERATIVE VISION: J2, 20/60. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT WAS PRESCRIBED MEDICATION. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED STATING DXR00V IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. PATIENT STATUS AFTER DXR00V EXPLANT WAS CONFIRMED AS STILL TEMPORARILY IMPAIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Halo; Visual Disturbances; Vitreous Floaters

  MAUDE report 16185322 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DXR00VU19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO VISUAL DISCOMFORT, HAZY VISION AND REPLACED WITH A DXW150 18.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, AND NO DELAY IN PROCEDURE. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury; Visual Disturbances

  MAUDE report 16164271 ↗