TECNIS IOL ZCT525 (REF ZCT525U240)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 24.0D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474603653), received between Dec 20, 2017 and Nov 1, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product1
- Packaging Problem1
Patient problems
- No Code Available1
- No Patient Involvement1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2018Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem
IT WAS REPORTED THAT TECHNICIAN OPENED ALL THREE STERILE POUCHES OF INTRAOCULAR LENS PACKAGING. SCRUB THREW OUTER PACKAGING AWAY. WHEN OPENED LENS HOLDER THERE WAS NO INTRAOCULAR LENS. LATER THE PACKAGING WAS REMOVED FROM TRASH AND THERE WAS INTRAOCULAR LENS FOUND IN THE SECOND STERILE POUCH WHICH WAS RIPPED. THE POUCH WAS TAPED AND WAS CIRCLED WHERE THERE WAS RIPPED AND WAS SENT BACK FOR INVESTIGATION. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8029328 ↗InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZCT525 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT''S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT WASN''T SEEING WELL, PROBABLY DUE TO AN INAPPROPRIATELY CHOSEN LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A ZCT225 23.5 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE STATUS OF THE PATIENT POST-OPERATIVELY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Impairment
MAUDE report 7136138 ↗
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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