TECNIS IOL DXW300 (REF DXW300U200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 20.0D CYL3.00 · 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 05050474765337), received between Aug 23, 2024 and Aug 23, 2024 — 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
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENTS BOTH RIGHT AND LEFT EYE. THE DIRECTIONS FOR USE WERE FOLLOWED. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT REPORTED GLARE AND HALOS. AS OF JUNE 20, 2024, THE PATIENT'S OUTCOME WAS REPORTED AS FULLY RECOVERED. HOWEVER, IT WAS ALSO REPORTED THAT THE PATIENT IS SCHEDULED FOR AN EXPLANT. THE EXPLANT FOR BOTH EYES SUBSEQUENTLY OCCURRED. THE SERIAL NUMBERS WERE PROVIDED BUT THE EYE WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THE MDR FOR SERIAL # (B)(6) IS CAPTURED IN MANUFACTURER REPORT NUMBER 3012236936-2024-0002362 . THE OTHER EYE SERIAL #: (B)(6) IS CAPTURED IN MANUFACTURER REPORT NUMBER 3012236936-2024-0002363.
Patient problems: Halo; Visual Disturbances
MAUDE report 20057991 ↗
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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