TECNIS IOL DXW225 (REF DXW225U050)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 05.0D 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474763852), received between Nov 3, 2024 and Nov 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Fold, Unfold or Collapse1
- Ejection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2024Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem
THE PRE-LOADED DXW225 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN FULLY INSERTED IN THE PATIENT'S EYE HOWEVER, THE IOL WOULD NOT UNFOLD AND THE HAPTIC WAS STUCK TO THE CARTRIDGE. DURING THE SAME PROCEDURE THE SUSPECT IOL WAS REMOVED AND REPLACED WITH ANOTHER DXW225 5.0 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WERE REQUIRED DURING THE PROCEDURE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS FINE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20595715 ↗
Other intraocular lens devices
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- 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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