TECNIS IOL ZCT525 (REF ZCT525U210)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 21.0D 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 05050474603592), received between Mar 16, 2017 and Oct 9, 2019 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- 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.
InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A MODEL ZCT525 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING BLURRY VISION. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCT225, 21.5 DIOPTER IOL. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, SUTURES OR VITRECTOMY REQUIRED. IT WAS NOTED THE PATIENT WAS DOING WELL POST-EXCHANGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 9170219 ↗InjuryMar 16, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) ROTATED AFTER IMPLANTATION. REPORTEDLY, THE SURGEON WAS PLANNING ON KEEPING THE LENS IN THE PATIENT'S EYE AND REPOSITIONING THE LENS IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS ROTATED BY 36 DEGREES POST IMPLANTATION BUT THE LENS WAS NOT REPOSITIONED. THE PATIENT UNDERWENT A PRK (PHOTOREFRACTIVE KERATECTOMY) PROCEDURE INSTEAD. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6411931 ↗
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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