TECNIS IOL DXW225 (REF DXW225U210)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 21.0D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474764170), received between Oct 14, 2024 and Feb 6, 2025 — classified as 2 injuries, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Blurred Vision1
- Capsular Bag Tear1
- Eye Injury1
- Flashers1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 21329641 ↗MalfunctionDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A POSSIBLE BURR ON THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL). CURRENTLY, THE LENS HAS NOT BEEN EXPLANTED, AND THERE ARE NO IMMEDIATE PLANS TO EXPLANT THE LENS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO EVIDENT BURR ON LEAD HAPTIC HOWEVER LENS WAS INSERTED AND ROTATED INTO PLACE, WHILE I/A OUT VISCOELASTIC BAG HAD BROKEN EVEN WITH NO I/A CONTACT. THE LENS WILL BE EXPLANTED IN A FEW MONTHS AFTER BAG STABILIZES. THE PATIENTS VISION WAS POOR. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Capsular Bag Tear
MAUDE report 21019990 ↗InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE TORIC LENS HAD EXPLANTED DUE TO A PATIENT COMPLAINT ABOUT SEVERE STARBURST AFFECTING NIGHT DRIVING. THE PATIENT UNDERWENT AN IOL EXCHANGE AND ANOTHER J&J LENS WAS SUCCESSFULLY IMPLANTED WITH NO FURTHER COMPLICATIONS. ADDITIONAL INFORMATION SUGGESTED THAT THE PATIENT'S GLARE WAS GONE POST-SURGERY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Flashers; Visual Disturbances
MAUDE report 20447461 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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