TECNIS IOL ZCT525 (REF ZCT525U115)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 11.5D 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474603400), received between Sep 7, 2018 and Sep 7, 2018 — classified as 1 injury.
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
- Unintended Movement1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2018Unintended Movement; Unintended Movement
THE SURGERY CENTER REPORTED OF AN UNEXPECTED POST-OP OUTCOME DUE TO A POSSIBLE ROTATION OF A TORIC INTRAOCULAR LENS (IOL), MODEL ZCT525 (11.5 DIOPTER). IT WAS INDICATED THAT THE INITIAL POSITION OF THE IOL TARGETED AT 87 DEGREES UPON IMPLANTATION THE PATIENT PRESENTED AS 20/30 AFTER CATARACT SURGERY ON DAY ONE. THE PATIENT THEN PROCEEDED TO SAY IT WAS ALMOST AS IF SHE NOTICED THE LENS ROTATED ITSELF, NOW HER VISION IN THAT EYE, LEFT EYE (OS) IS 20/80 JUST UNDER 1-MONTH POSTOP. IT WAS INDICATED THAT THE DOCTOR WANTS TO ROTATE THE LENS AROUND 13-20 DEGREES TO GIVE THE PATIENT OPTIMAL VISION. PRE-OPERATIVE REFRACTION: -1300 +200 X 085. POST-OP REFRACTION -100 +150 X 150. BEST CORRECTED VISUAL ACUITY (BCVA): 20/30. ON (B)(6) 2018 VISIT, THE CURRENT ORIENTATION OF IOL: WAS REPORTED TO BE 82 DEGREES. IT WAS INDICATED THAT THE INITIAL POSITION OF THE LENS WAS TARGETED AT 87 DEGREES UPON IMPLANTATION; HOWEVER, THE ACCOUNT WAS NOT SURE IF THAT WAS THE POSITION AT WHICH THE IOL WAS ACTUALLY PLACED. THE CURRENT POSITION OF THE LENS WAS REPORTED TO BE 87 DEGREES. THE ACCOUNT CONSULTED WITH THE J&J SURGICAL MEDICAL AFFAIRS AND AFTER REVIEWING THE PATIENT DATA, MEDICAL AFFAIRE DETERMINED IT APPE
Patient problems: No Code Available
MAUDE report 7855160 ↗
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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