TECNIS IOL DXW225 (REF DXW225U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 16.0D 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 05050474764071), received between Jan 26, 2026 and Jan 26, 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
- Blurred Vision1
- Posterior Capsule Opacification1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
THE DXW225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DURING A FOLLOW-UP VISIT, A FILM WAS OBSERVED BEHIND BOTH LENSES, WHICH IS A KNOWN OCCURRENCE IN APPROXIMATELY 1 IN 5 PATIENTS. THE PATIENT WILL REQUIRE A LASER PROCEDURE TO ADDRESS THE ACCUMULATIONS. THE LENSES WERE NOTED TO BE IN GOOD CONDITION. THE PATIENT LATER REPORTED EXPERIENCING COLOR DISTORTION AND BLURRY VISION IN BOTH EYES STARTING IN (B)(6) 2025, THOUGH THESE ISSUES WERE NOT DEBILITATING. AN FES LASER PROCEDURE WAS PERFORMED (B)(6) 2026. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. PATIENT PROGNOSIS POST LASER PROCEDURE WAS REPORTED AS FULL SIGHT RESTORED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMANS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Posterior Capsule Opacification; Visual Disturbances
MAUDE report 24178498 ↗
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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