TECNIS IOL DXR00V (REF DXR00VU205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474761803), received between Jun 29, 2022 and Feb 26, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED NIGHT DRIVING DIFFICULTIES FOLLOWING IMPLANTATION OF A PRELOADED EXTENDED DEPTH OF FOCUS (EDOF) INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE VISUAL SYMPTOMS WERE CHARACTERIZED AS POOR MULTIFOCAL TOLERANCE AND WERE FIRST OBSERVED POSTOPERATIVELY. THE IMPLANTED EDOF IOL WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY PROCEDURE AND REPLACED WITH A SINGLE PIECE PRELOADED MONOFOCAL IOL WITH A POWER OF +21.0 DIOPTERS. THE PATIENT¿S PRE OPERATIVE AND POST OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) REMAINED 20/20. NO UNPLANNED SURGICAL INTERVENTIONS WERE REQUIRED, INCLUDING INCISION ENLARGEMENT, SUTURING, OR VITRECTOMY. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED, AND NO SURGICAL DELAYS WERE REPORTED. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE PRE OPERATIVE REFRACTION AS +2.50 ¿0.25 × 93 AND THE POST OPERATIVE REFRACTION AS +0.25 SPHERE. THE INTENDED TARGET REFRACTION WAS PLANO. THE PATIENT DID NOT LOSE TWO OR MORE LINES OF BSCVA AND WAS NEITHER UNDER NOR OVER CORRECTED. BASED ON THE INFORMATION PROVIDED, THE DEVICE WAS CONSIDERED TO HAVE

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24464448 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY AND DID NOT ADJUST WELL TO THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DXR00V THAT WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING MODERATE TO SEVERE BLURRED VISION, PHOTOPHOBIA, AND GLARE OF THE LEFT EYE. THE PATIENT DID NOT SHOW IMPROVEMENT OVER SEVERAL MONTHS WHICH LED TO THE DECISION TO HAVE THE LENS EXPLANTED BY ANOTHER SURGEON AT A DIFFERENT SURGERY CENTER. THE COMPLAINT DEVICE IS DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23399232 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED VISUAL DISTURBANCES AFTER THE IMPLANTATION OF PRELOADED MULTIFOCAL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS. CONSEQUENTLY, LENS WAS EXPLANTED DURING SECONDARY SURGERY AND REPLACED WITH ANOTHER MODEL LENS. THERE WAS NO REPORT OF UNPLANNED VITRECTOMY AND SUTURES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 22366400 ↗
• InjuryMay 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE AROUND (B)(6) 2024. THE PATIENT SAID HIS WHOLE GOAL WAS TO BE ABLE TO READ WITHOUT GLASSES. INSTEAD, HE STILL HAS MANY GLASSES THAT HE USES TO READ. THE PATIENT SAID THAT HE MAY NOT HAVE TOLD HIS DOCTOR THAT HIS GOAL WAS TO BE ABLE TO READ WITHOUT GLASSES. THE PATIENT EXPERIENCED BLURRED VISION IN HIS RIGHT EYE WHICH HIS DOCTOR ATTRIBUTES TO HIS MACULAR DEGENERATION. THE DOCTOR EXPLAINED TO THE PATIENT THAT HIS MACULAR DEGENERATION IS NOT DUE TO THE IOL. THE ISSUE WAS FIRST NOTICED DURING A POST-OPERATIVE VISIT APPROXIMATELY ONE WEEK AFTER THE IMPLANT. INITIALLY, THE DOCTOR HAD SCHEDULED AN EXPLANT BUT WAS SUBSEQUENTLY CANCELLED. HIS DOCTOR SAID THE IOL MOVED AND IN (B)(6) 2024 THE LENS WAS REPOSITIONED. THE PATIENT SAID HE WILL SEEK A SECOND OPINION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 22102352 ↗
• InjuryApr 3, 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 OPERATIVE EYE. DUE TO UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND INFORMATION REGARDING THE REPLACEMENT IOL IS UNAVAILABLE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21767313 ↗
• MalfunctionOct 17, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT PRELOADED MULTIFOCAL LENS WAS SCRATCHED AND NOT USED DURING SURGERY. THERE WAS NO PATIENT CONTACT. A BACKUP LENS WAS SUCCESSFULLY USED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472443 ↗
• InjuryApr 12, 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'S RIGHT EYE AS THE PATIENT WAS DISSATISFIED WITH THE LENS. A MONOFOCAL LENS, MODEL ZCB00 OF 21.0 DIOPTER WAS USED AS A REPLACEMENT LENS. THERE WAS NO VITRECTOMY REQUIRED AND NO INCISION ENLARGEMENT MADE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 19097560 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HYPEROPIC SURPRISE (+1.25) AND NEGATIVE DYSPHOTOPSIA WITH AN INTRAOCULAR LENS (IOL). THEREFORE, THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE . THE SURGEON REPORTED THE PATIENT IS DOING FINE AND DOES NOT FEEL THIS WAS ANY FAULT OF THE LENS. THE SURGEON COMMENTED IT WAS QUITE REMARKABLE THAT THE PATIENT'S VISION WAS STILL 20/25 UNCORRECTED EVEN WITH SUCH A HYPER SURPRISE AND IT SHOWS IT'S TRUE EDOF (EXTENDED DEPTH OF FOCUS INTRAOCULAR) BENEFITS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT ANOTHER JOHNSON & JOHNSON AR40E LENS (DIFFERENT MODEL AND 21.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE EXPLANTED LENS WAS DISCARDED. PRE-OPERATIVE (OP) UNCORRECTED VISUAL ACUITY (UCVA) WAS: UCVA 20/200, 20/80. POST-OP UCVA 20/20 -2 (1 DAY), 20/25 +1 (1 WEEK), BCVA (BEST-CORRECTED VISUAL ACUITY) WITH MR (MANIFEST REFRACTION) 20/20. THERE WAS NO PATIENT INJURY. A CAPSULAR TENSION RING (CTR) WAS USED DURING SURGERY AS THE SURGEON USES THEM FREQUENTLY (AS A STANDARD OF CARE TO GIVE STABILITY) BECAUSE THE PATIENT HAS PHACODENESIS. THE PATIENT'S POST-OPERATIVE OUTCOME REPORTED UCVA 20/50 (1 DAY) GLARE & HALOS/LIGHT SENSITIVITY. 1 WEEK POST OP VISIT WAS SCHEDUL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment

  MAUDE report 14860691 ↗