TECNIS IOL ZCU300 (REF ZCU300U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 14.0D CYL3.00 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474660038), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 malfunction.
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
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2020Unintended Movement; Unintended Movement
IN A CLINICAL RESEARCH STUDY, DURING A MONITORING VISIT, THE SITE NOTED AN INTRAOCULAR LENS (IOL) ROTATION OF 19 DEGREES IN THE PATIENT¿S RIGHT EYE (OD) ON (B)(6) 2020. IOL AXIS PLACEMENT: 95 PRE-OPERATION BEST CORRECTED VISUAL ACUITY (BCVA): 20/25 OD; 20/100 OS. 1-WEEK VISIT ON (B)(6) 2020: UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): OD: 20/15 -1, IOL AXIS PLACEMENT: 76. IT WAS INDICATED THAT THERE NO PLANS FOR INTERVENTION AT THIS TIME. THE SUBJECT WAS SCHEDULED TO COME IN FOR THE 3-MONTH VISIT ON (B)(6) 2020. THE SUBJECT HAD THE 3-MONTH POST-OPERATIONAL VISION ON THE RIGHT EYE (OD) ON (B)(6) 2020. THE AXIS PLACEMENT WAS REPORTED AT 79 DEGREES. THERE WAS NO PRODUCT COMPLAINT REPORTED. THE PATIENT DENIED ANY VISUAL COMPLAINTS OR SYMPTOMS. NO PLANNED INTERVENTION WAS REPORTED. THE DOCTOR DETERMINED THAT THE CHANGE IN AXIS WAS PROBABLY DUE TO HEAD TILT DAY OF SURGERY GIVEN GOOD OUTCOME OF VISUAL ACUITY. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): OD- 20/25-2, BCDVA- 20/20+1. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10445855 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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