TECNIS IOL DXR00V (REF DXR00VU180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLCTY TECNIS SYMF ERV OB 18.0D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474761759), received between Mar 2, 2024 and Nov 7, 2024 — classified as 3 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 Problem3
Patient problems
- Flashers1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2024Adverse 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 EXPLANTED BECAUSE THE PATIENT COMPLAINED OF INTOLERABLE HALOS AND GLARE AT NIGHT AND IS UNABLE TO DRIVE IN THE DARK. THE PATIENT¿S STATUS WAS REPORTED AS TEMPORARILY IMPAIRED. BOTH THEIR PRE AND POST-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) IS 20/20. THE INCISION WAS ENLARGED. SUTURES WERE USED PROPHYLACTICALLY AND MYOPIC DROPS WERE PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 20635284 ↗InjuryMar 29, 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 AND REPLACED WITH A MONOFOCAL DCB00 LENS DUE TO PATIENT COMPLAINING OF STARBURSTS. THE SURGERY WENT WELL AND NO EXTENSION OF THE INCISION, NO SUTURE AND NO SURGICAL COMPLICATION REPORTED. IT WAS NOTED THAT THE OTHER EYE STILL HAS THE PATIENTS NATURAL LENS (NO SURGERY). NO FURTHER INFORMATION WAS REPORTED.
Patient problems: Flashers
MAUDE report 19005307 ↗InjuryMar 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNEXPECTED MYOPIC RESULTS. THERE WAS NO CAPSULE TEAR, VITRECTOMY, OR SUTURES. THE IOL WAS REPLACED WITH A BAUSCH AND LOMB MONOFOCAL LENS. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 18823352 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page