TECNIS IOL ZCT600 (REF ZCT600U160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 16.0D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604087), received between May 5, 2017 and Dec 2, 2020 — 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
- Blurred Vision1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) HAD ROTATED 24 DEGREES AFTER ONE WEEK POSTOP WITH MANIFEST REFRACTION (MRX) >1.6 SPHERICAL EQUIVALENT. PATIENT WAS 20/20 UNCORRECTED AT POST-OP DAY 1. AT POSTOP WEEK 1, HER VISION WAS 20/100. THE SURGEON PLANNED ON ROTATION ONLY, BUT THE PATIENT WAS -1.5 SO THE SURGEON DECIDED ON A LENS EXCHANGE WITH A LOWER DIOPTER. HOWEVER, THE OCULAR RESPONSE ANALYZER (ORA) STATED TO USE THE SAME DIOPTER 16.0 AGAIN. THE PATIENT ALSO EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH THE SAME MODEL AND DIOPTER. THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 10933213 ↗MalfunctionMay 5, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) HAD ROTATED BY 23 DEGREES POST IMPLANTATION. REPORTEDLY, THE POST-OP STATUS OF THE PATIENT WAS STABLE. THERE WERE NO INJURIES AND NO COMPLAINTS FROM THE PATIENT. TO DATE THE LENS REMAINS IMPLANTED AND THERE ARE NO PLANS TO REPOSITION THE LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6546639 ↗
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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