TECNIS IOL DXR00V (REF DXR00VU275)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SIMPLCTY TECNIS SYMF ERV OB 27.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474761940), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED INTRALOCULAR (IOL) LENS WAS EXPLANTED FROM PATIENT'S FROM LEFT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ LENS IN A SECONDARY PROCEDURE. THE PATIENT IS GOOD. FROM ADDITIONAL INFORMATION IT WAS LEARNED THAT THE PATIENT HAD LOTS OF GLARES. THE PRE-OP BEST CORRECTED VISUAL ACUITY IS DC120/100-2 AND THE POST-OP (POST-INITIAL IMPLANT) BEST CORRECTED VISUAL ACUITY, IS 20/30-1. THE INTENDED/TARGETED POST-OPERATIVE REFRACTION (FOR INITIAL IMPLANT) IS (S) -0.75 (CYL)-1.00 (A) 19. BSS WAS USED IN AS CARTRIDGE LUBRICATION AND WAS USED AT ROOM TEMPERATURE. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 18937869 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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