TECNIS IOL ZCT300 (REF ZCT300U155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 15.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553231), received between Nov 7, 2016 and Feb 7, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (2 reports).
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
- Unintended Movement2
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2018Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ROTATION HAD OCCURRED AND WAS FOUND DURING THE PATIENT'S POST OP FOLLOW UP VISIT. THEREFORE, THE SURGEON PLANNED AN IOL REPOSITIONING SURGERY ON (B)(6) 2018. THE INTRAOCULAR LENS WAS PLACED AT 88 DEGREES THE DAY OF SURGERY ((B)(6) 2017) AND WAS MEASURED AT A FOLLOW-UP VISIT ((B)(6) 2018) AT 101 DEGREES WHICH ACCOUNTS FOR A 13-DEGREE DIFFERENCE. IT WAS REPORTED THAT THE PATIENT OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Code Available
MAUDE report 7249131 ↗MalfunctionNov 7, 2016Unintended Movement; Unintended Movement
THE INTRAOCULAR LENS WAS IMPLANTED IN THE RIGHT EYE, AND IT WAS NOTED THAT THERE WAS LENS MISALIGNMENT OF 46 DEGREES BETWEEN THE OPERATIVE PLACEMENT AND THE LENS POSITION AT THE 6 MONTH VISIT. PATIENT HAS NO COMPLAINTS WITH THEIR VISION AND NO SECONDARY SURGERY IS PLANNED. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION OR RELATED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6081110 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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