TECNIS IOL DXW225 (REF DXW225U105)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 10.5D CYL2.25 · 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 05050474763968), received between Feb 3, 2026 and Feb 3, 2026 — 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
- Flashers1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DXW225, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. POSTOPERATIVELY, THE PATIENT EXPERIENCED INTOLERANCE TO GLARE AND STARBURST VISUAL EFFECTS, WHICH PREVENTED THE PATIENT FROM PERFORMING CERTAIN ACTIVITIES THAT WERE POSSIBLE PRIOR TO SURGERY, SPECIFICALLY, NIGHT DRIVING. ADDITIONAL INFORMATION CONFIRMED THAT THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. THE ORIGINAL TARGET REFRACTION WAS -0.25, AND THE ISSUE WAS DETERMINED NOT TO BE REFRACTIVE IN NATURE. THE EXPLANTED LENS WAS REPLACED WITH A ZCU150 MODEL LENS. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR MEDICATIONS BEYOND STANDARD POSTOPERATIVE CARE WERE REQUIRED. AT THE 1-DAY POSTOPERATIVE FOLLOW-UP, THE PATIENT REPORTED NO PROBLEMS, AND NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Flashers; Visual Disturbances
MAUDE report 24248800 ↗
Other intraocular lens devices
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- 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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