TECNIS IOL ZCU225 (REF ZCU225U155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 15.5D 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
- 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 05050474658882), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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.
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Blurred Vision1
- Dry Eye(s)1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PATIENT HAS A POST OPERATIVE (OP) REFRACTION +1.50-.50X75 WITH AN INTRAOCULAR LENS (IOL). EYE EXAM USING SNELLEN CHART: OS 20/30 -1 PH: 20/20. AUTO REFRACTION: OS +1.00 -0.25 X 055. MANIFEST REFRACTION: OS +1.50 -0.50 X 075 ADD +2.50 DCC: 20/20 NCC: J1+. PATIENT REPORTS IN THE LEFT EYE, THINGS ARE NOT AS CLEAR AS THEY WERE RIGHT AFTER SURGERY. THE PATIENT IS USING EYE DROPS TO HELP WITH DRYNESS, BUT THAT HAS NOT MADE ANY CHANGES TO THE VISION. ADDITIONAL INFORMATION WAS REPORTED THAT THE IOL ROTATED 10 DEGREES. IOL AXIS PLACEMENT: 177, PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA): 20/40. AT A 3-MONTH VISIT ((B)(6) 2020), IOL AXIS PLACEMENT: 180, BCVA OS: 20/20+2. IN AN UNSCHEDULED VISIT ON (B)(6) 2020, PATIENT COMPLAINED OF BLURRY VISION. UNCORRECTED VISUAL ACUITY (UCDVA) OS: 20/30, BCDVA OS: 20/20, AND IOL AXIS PLACEMENT: 170 (10 DEGREES FROM LAST MEASURED AT 3 MONTH VISIT). AT THIS TIME, THERE ARE NO PLANS FOR INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Dry Eye(s); Therapeutic Effects, Unexpected
MAUDE report 10446144 ↗
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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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