TECNIS IOL ZCT525 (REF ZCT525U225)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 22.5D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474603622), received between Oct 17, 2017 and Aug 28, 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 18, 2026.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
- Unintended Movement1
Patient problems
- No Code Available2
- Blurred Vision1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT525 +22.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO AN INCORRECT REFRACTION. REPORTEDLY, ANOTHER LENS WITH THE SAME MODEL BUT DIFFERENT DIOPTER SIZE, WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7821947 ↗InjuryOct 17, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A ZCT525 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017 AND ROTATED TO 135 DEGREES FROM THE TARGET DEGREE OF 100, WHICH WAS A DIFFERENCE OF 35 DEGREES. IN ADDITION, THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/70 AND SHE COMPLAINED OF BLURRY VISION. THEREFORE, A SECOND SURGERY WAS PERFORMED ON (B)(6) 2017 TO ROTATE THE LENS BACK TO THE 100 DEGREE TARGET. POST-OPERATIVELY, THE LENS MOVED TO 110 DEGREES AND THE PATIENT'S VISUAL ACUITY WAS 20/30. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 6956762 ↗
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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