TECNIS IOL DXR00V (REF DXR00VU130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLCTY TECNIS SYMF ERV OB 13.0D · 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 05050474761650), received between Feb 26, 2024 and Feb 7, 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
- Halo2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRE-LOADED DXR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE. DUE TO COMPLAINTS OF POWER MISS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DXR00V 12.0 DIOPTER IOL. THE PATIENT ALSO HAD COMPLAINTS OF HALOS AND BLURRY VISION THAT SHE COULD NOT ADAPT TO. THE FOLLOWING ARE ALL UNKNOWNS: PATIENT INJURY, MEDICAL INTERVENTION, AND SURGICAL INTERVENTION. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS DOING WELL NOW WITH A VISUAL ACUITY OF 20/25+1 (J1) OD AND 20/30-1 (J1) OS. NO FURTHER INFORMATION IS AVAILABLE. 03-FEB-2025 PRODUCT INVESTIGATION (B)(4) WAS COMPLETED WITHOUT DEVICE VISUAL INSPECTION AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WAS IDENTIFIED. RESULTS WERE INCLUDED IN THE INITIAL REPORT SUBMISSION.
Patient problems: Blurred Vision; Halo; Visual Impairment
MAUDE report 21332648 ↗InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO HALO. IT IS UNKNOWN IF A BACKUP IOL WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. PATIENT STATUS POST-PROCEDURE IS GOOD. NO FURTHER INFORMATION PROVIDED.
Patient problems: Halo
MAUDE report 18784950 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- 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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