TECNIS IOL ZCT600 (REF ZCT600U130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 13.0D CYL6.00 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604025), received between Mar 21, 2017 and Jul 9, 2020 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision2
- No Code Available2
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT HAVING A HISTORY OF KERATOCONUS, THEREFORE, IT IS DIFFICULT TO GET ACCURATE MEASUREMENTS. THE LENS WAS NOT THE RIGHT FIT FOR THE PATIENT AFTER ALL. THE PATIENT HAD BLURRY VISION AND HAD A HARD TIME READING. THE INCISION WAS ENLARGED, UNPLANNED SUTURES, AND AN ANTERIOR VITRECTOMY WERE REQUIRED. THE REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED WITH A DIFFERENT MODEL AND LOWER DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available; Vitrectomy
MAUDE report 10253878 ↗InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT600 13.0 DIOPTER WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO PATIENT EXPERIENCING BLURRY VISION. IT WAS ALSO REPORTED THAT THE PATIENT'S VISION WAS AFFECTING THEIR DRIVING AND READING. THE PATIENT STATED THAT THE LEFT EYE HAD TO BE CLOSED TO BE ABLE TO READ. PATIENT'S VISUAL ACUITY WAS 20/60. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 12.0 DIOPTER. THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT AND NO POST-OP INJURY REPORTED FOR THIS EVENT.
Patient problems: Blurred Vision; No Code Available
MAUDE report 6421465 ↗
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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