TECNIS IOL DXW300 (REF DXW300U155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 15.5D 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 05050474765245), received between Jan 13, 2025 and Jan 13, 2025 — 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
- Blurred Vision1
- Flashers1
- Halo1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DXW300 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE BEEN IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT IS UNHAPPY WITH THE LENSES THAT WERE IMPLANTED. PATIENT DESCRIBED EXPERIENCING VISUAL FLUTTERING IN HIS VISION SINCE IMPLANTATION, SIMILAR TO A STROBE LIGHT. IT IS ESPECIALLY HARD WHEN HE READS. POOR NIGHT VISION. AT NIGHT, THE PATIENT DOES NOT SEE MUCH LIGHT. HE PROVIDED EXAMPLES OF DIFFICULTY WALKING HIS DOG AT NIGHT AND TROUBLE GETTING OUT OF BED IN THE NIGHT WITHOUT BEING ABLE TO SEE. PATIENT EXPERIENCES DIFFICULTIES WITH DRIVING AND SEES HALOS. HE HAD CATARACT SURGERY, TO ELIMINATE AN ASTIGMATISM. HE WORE GLASSES AND OVER THE YEARS, HIS PRESCRIPTION REMAINED UNCHANGED. HE'S NOW HAVING TROUBLE OBTAINING GLASSES TO ASSIST HIS VISUAL ISSUES. PATIENT SHOWS NO SYMPTOMS OF GLAUCOMA, MACULAR DEGENERATION, OR DRY EYE. EYE PRESSURE IS GOOD: 11 AND 13. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, CLAREON CCA020 LENS. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. THE SUSPECT IOL IS NOT A
Patient problems: Blurred Vision; Flashers; Halo
MAUDE report 21146376 ↗
Other intraocular lens devices
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- 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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