TECNIS IOL ZCT600 (REF ZCT600U125)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 12.5D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604018), received between Jun 9, 2017 and Dec 27, 2017 — classified as 1 injury, 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Unintended Movement1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SUBJECT HAD THE INTRAOCULAR LENS IMPLANTED ON (B)(6) 2017, AND A MISALIGNMENT OF 11 DEGREES FROM 93 DEGREES TO 82 DEGREES WAS NOTED AT THE 1-MONTH VISIT FOR THE LEFT EYE. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT IS STABLE AND DOESN''T WANT TO SEEK ANY TREATMENT AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: PATIENT HAD BILATERAL LENS IMPLANTS; THEREFORE, TWO REPORTS ARE BEING SUBMITTED, ONE FOR EACH IMPACTED EYE. THIS REPORT CAPTURES THE EVENT FOR THE LEFT EYE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7150191 ↗InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT600 12.5 DIOPTER WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO A DECREASE IN VISION. PATIENT IS UNABLE TO READ OR WATCH TELEVISION. THE LENS WAS REPLACED WITH A ZCT225 IOL WITH A HIGHER DIOPTER (15.5). THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Impairment
MAUDE report 6629029 ↗
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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