TECNIS IOL ZCT525 (REF ZCT525U195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 19.5D CYL5.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474603561), received between Apr 27, 2017 and Jul 10, 2018 — 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 18, 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
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2018Unintended Movement; Unintended Movement
REPORTEDLY, A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE. THE LENS WAS PLACED AT 94 DEGREES AT IMPLANT AND WAS MEASURED AT THE 6-MONTH STUDY VISIT ON (B)(6) 2018, AT 84 DEGREES. THERE WAS NO INJURY OR PATIENT COMPLICATION. THE LENS ROTATION DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE FOR THE PATIENT. THE PRODUCT WILL BE RETURNED AS IT REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7674767 ↗InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT225 16.5 DIOPTER WAS EXPLANTED FROM A MALE PATIENT''S LEFT EYE DUE TO RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXPLANTED WITH NO COMPLICATIONS, NO INJURY AND NO ADDITIONAL PROCEDURES. THE LENS WAS REPLACED WITH A ZCT600 WITH A HIGHER DIOPTER SIZE. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6526686 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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