TECNIS IOL DXR00V (REF DXR00VU235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLCTY TECNIS SYMF ERV OB 23.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474761865), received between May 10, 2025 and Aug 29, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision1
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT INITIALLY REPORTED A PLANNED EXPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) DRIVEN BY THE PATIENT'S PREFERENCE FOR IMPROVED NEAR VISION. ADDITIONALLY, IT WAS NOTED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE ON (B)(6) 2025 DUE TO POOR NEAR VISION. THE REPLACEMENT LENS WAS A DIFFERENT MODEL (DRN00V), BUT OF THE SAME DIOPTER AS THE ORIGINAL LENS. NO UNPLANNED SURGICAL INTERVENTIONS OCCURRED, AND NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE REQUIRED. THERE WAS NO REPORT OF PATIENT INJURY. POST-OPERATIVELY, THE PATIENT'S VISION WAS GOOD AT 20/40, AS ASSESSED ON DAY-ONE. NO FURTHER DETAILS HAVE BEEN PROVIDED.
Patient problems: Blurred Vision
MAUDE report 22926486 ↗InjuryMay 10, 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). DUE TO COMPLAINTS OF MECHANICAL COMPLICATIONS - DRIVING ISSUES AND HALOS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, RX SIGHT LIGHT ADJUSTABLE LENS. THERE WAS NO MEDICAL INTERVENTION, NO PATIENT INJURY, AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST-LENS EXCHANGE WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 21999708 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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