TECNIS IOL DXR00V (REF DXR00VU170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLCTY TECNIS SYMF ERV OB 17.0D · 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 05050474761735), received between Feb 26, 2024 and Oct 29, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Application Program Problem: Dose Calculation Error1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Eye Injury1
- Halo1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2024Adverse 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 PATIENT'S LEFT EYE DUE TO PATIENT COMPLAINING OF VISUAL DISTURBANCE/HALOS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS HAD CONTRIBUTED FOR THE INTOLERABLE HALOS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THERE WAS NO PATIENT INJURY AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. HALOS HAVE GONE. THE SYMPTOMS HAD SIGNIFICANTLY INTERFERED WITH ONE OR MORE DAILY ACTIVITIES. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Halo
MAUDE report 20560084 ↗InjuryFeb 26, 2024Application Program Problem: Dose Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Dose Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE WRONG POWER. THE SUSPECT IOL WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON SAME MODEL HIGHER DIOPTER IOL. PATIENT STATUS POST-PROCEDURE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury; Visual Impairment
MAUDE report 18785362 ↗
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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