TECNIS IOL ZCT525 (REF ZCT525U105)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 10.5D CYL5.25 · 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 05050474603387), received between Nov 15, 2016 and May 8, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
- Unintended Movement1
Patient problems
- No Code Available2
- 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.
InjuryMay 8, 2018Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (MODEL ZCT525 +10.5 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. THERE WERE NO PATIENT COMPLICATION AND/OR RELATED INJURY. THE INTRAOCULAR LENS (IOL) ORIGINALLY PLACED AT 16 DEGREES, WAS MEASURED AT 37 DEGREES ONE DAY POST-OP ON (B)(6) 2018. REPORTEDLY, THERE ARE NO PLANS FOR IOL REPOSITIONING. THE LENS REMAINS IMPLANTED IN THE EYE. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERES WITH THE PATIENT'S DAILY ACTIVITIES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7497493 ↗InjuryNov 15, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN INCORRECT CYLINDER AND SPHERE POWER FOR THE PATIENT. THE LENS WAS REPLACED WITH THE SAME MODEL TYPE; A SLIGHTLY, SMALLER DIOPTER LENS (10.0). THE AFFECTED WAS THE RIGHT EYE. THERE WAS NO POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6105074 ↗
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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