TECNIS IOL DXW300 (REF DXW300U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 16.0D CYL3.00 · 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 05050474765252), received between Jan 12, 2024 and Jan 12, 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 Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 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 RIGHT EYE DUE TO POWER SURPRISE, MARKED DEVIATION FROM MEASURED TARGET OBSERVED FIRST DURING POST-OP EXAM. THE LENS WAS EXPLANTED AND REPLACED WITH DXR00VU140 IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO PATIENT INJURY, DAILY ACTIVITIES OF THE PATIENT WERE NOT AFFECTED. THERE WAS INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE INTENDED/TARGETED POST-OPERATIVE REFRACTION (FOR INITIAL IMPLANT) WAS :-0.50. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 18507959 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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