TECNIS IOL ZXW300 (REF ZXW300U180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMF TORIC II OB 18.0D 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 05050474733497), received between Jan 15, 2025 and Jan 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unstable1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2025Unstable; Unstable
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO REFRACTIVE SURPRISE, MYOPIC SURPRISE AND IOL MALROTATION. IT WAS INDICATED THAT ON (B)(6) 2024, THE NUMBERS LOOKED SUSPICIOUS BUT SINCE IT WAS 1-DAY POST-OP, THEY DECIDED TO WAIT LONGER. THEN ON (B)(6) 2024 THEY NOTICED THE PATIENT'S ISSUE. THE ROTATION WAS LESS THAN 10 DEGREES. THE REPLACEMENT LENS WAS OF THE SAME MODEL, BUT LOWER DIOPTER (17.5D). THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY OR COMPLICATIONS SUCH AS CAPSULE TEAR REPORTED. THE PATIENT OUTCOME ON (B)(6) 2025 WAS REPORTED TO BE -1, -0.5, 140, UNCORRECTED VISUAL ACUITY (VA) 20/50, WHICH IS WORSE THAN WHAT THE PATIENT SHOULD HAVE BEEN, WORSE MYOPIC THAN WHAT IT WAS WITH THE ORIGINAL LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 21164599 ↗
Other Extended depth of focus intraocular lens devices
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- 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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