TECNIS IOL DXW225 (REF DXW225U185)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 18.5D 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 05050474764125), received between Mar 29, 2024 and Mar 29, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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
- Application Program Problem: Dose Calculation Error1
Patient problems
- Blurred Vision1
- Headache1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
IT WAS REPORTED THAT DUE TO A TRANSCRIPTION ERROR THE INTRAOCULAR LENS USED ON THE PATIENT WAS OF INCORRECT POWER RESULTING IN THE PATIENT BEING OVERCORRECED BY 6 DIOPTERS. THE PATIENT COULD NOT FOCUS, READ, OR PERFORM A JOB AND SUFFERED HEADACHES DUE TO ANISOMETROPIA. THE LENS WAS EXPLANTED ON FEBRUARY 28 AND A REPLACEMENT IOL (JNJ, DIFFERENT DIOPTER) WAS IMPLANTE. THERE WAS NO INJURY, AND NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Headache; Visual Impairment
MAUDE report 19006112 ↗
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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