TECNIS IOL ZXW300 (REF ZXW300U225)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMF TORIC II OB 22.5D CYL3.00 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474733589), received between Jul 10, 2023 and Jul 10, 2023 — 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- 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.
InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED INITIALLY THAT THE CUSTOMER PLANNED TO EXPLANT AN INTRAOCULAR LENS (IOL). IT WAS LEARNED LATER THAT THE IOL WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AND REASON FOR EXPLANT WAS DUE TO DECREASED VISION, HALOS, ALL THE TIME SINCE SURGERY. WORSE AT NIGHT. THE PATIENT WAS SCARED TO DRIVE ESPECIALLY AT NIGHT. PATIENT IS EVEN BOTHERED BY LIGHTS IN HER HOUSE. EXPLANTED IOL WAS REPLACED WITH A DIU300 22.5 DIOPTER POWER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THERE WAS NO PATIENT INJURY, PATIENT DOING WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 17295502 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 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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