TECNIS IOL ZCU300 (REF ZCU300U120)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 12.0D 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 05050474659995), received between Jul 27, 2021 and Jul 27, 2021 — 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 16, 2026.
Most reported problems
Device problems
- Unstable1
Patient problems
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2021Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S DISTANCE VISION WAS BLURRY AND IT APPEARED DOUBLED AFTER THE IMPLANTATION OF ZCU300 MODEL INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE. AT THE 1 MONTH POST OPERATIVE (OP) VISIT, PATIENT PRESENTED WITH DIAGNOSTIC REFRACTION (DRX) +1.75 -1.25 X 55. IT WAS NOTICED THAT IOL HAD ROTATED 20 DEGREES OFF AXIS AND THE IOL WAS ROTATED BACK TO THE CORRECT AXIS ON (B)(6) 2021. POST ROTATION OF THE LENS, THE PATIENT OUTCOME WAS DRX +1.75 -0.75 X 93, WHICH WAS A HYPEROPIC RESULT AND NEEDED THE LENS TO BE EXPLANTED FROM PATIENT'S EYE IN A DIFFERENT SURGICAL PROCEDURE. THE INCISION WAS ENLARGED TO EXPLANT THE LENS FROM PATIENT'S EYE, BUT NO VITRECTOMY OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS ANOTHER TORIC LENS OF ZCU225 MODEL AND 14.0 DIOPTER. PATIENT/ USER OUTCOME: VISUAL ACUITY PRE-OPERATIVE: 20/30 -2, VISUAL ACUITY POST-OPERATIVE: 20/30 -2 DOUBLED, VISUAL ACUITY: +1.75-1.25 X 55 20/20 -1 PRE ROTATION + EXPLANT OF LENS. PATIENT WAS 20/20 UNCORRECTED DISTANCE VISION (UCDV) AT BOTH DAY 1 AND WEEK 1 POST EXPLANT AND WITH REPLACEMENT LENS. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 12229772 ↗
Other intraocular lens devices
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- 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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