TECNIS IOL DXW225 (REF DXW225U245)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 24.5D 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 05050474764248), received between Nov 8, 2022 and Nov 8, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Blurred Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2022Break; Break
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE SURGEON BELIEVES THE LENS WAS MISLABELED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS MORE MYOPIC THAN ANTICIPATED. THE PATIENT WAS COMPLAINING OF GLARE AND DECREASED DISTANCE VISION. THERE WAS NO PATIENT INJURY REPORTED. THERE WERE NO REPORT OF ANY VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES BEING REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT IOL. THE PATIENT OUTCOME WAS REPORTED AS BEING RIGHT ON TARGET. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT WAS OFF TARGET AND THE FORMULAS ALL LOOKED CORRECT, THEREFORE, THE SURGEON WAS THINKING THE IOL WAS MISLABELED. THERE WAS NO INCORRECT LABELS OR INCORRECT LABELING ON THE IOL BOX. THE SURGEON JUST THOUGHT BECAUSE OF THE AMOUNT OF DIOPTER THE PATIENT WAS OFF TARGET, IT LED THEM TO BELIEVE THERE WAS A MISLABEL OR DEFECT IN THE LENS. THE PATIENT DOES NOT HAVE ANY PATHOLOGY IN BOTH EYES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 15756941 ↗
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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