TECNIS IOL ZLU375 (REF ZLU375U295)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 29.5D CYL3.75 · Class 3 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474691322), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2024Contamination; Contamination
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. FOLLOWING INSERTION OF LENS, THE SURGEON REPORTED TO THE OPERATING ROOM (OR) STAFF THAT THERE WAS SOME "BLACK STRINGY MATERIAL" ON THE IMPLANT. THE SURGEON WAS ABLE TO IRRIGATE THE MATERIAL OFF OF THE IMPLANT AND OUT OF THE EYE. THE SURGEON CHOSE TO LEAVE THE IMPLANT IN PLACE. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES PERFORMED. NO OTHER SURGICAL/MEDICAL INTERVENTIONS IN THE FUTURE. IT WAS NOTED THAT POST-OP PATIENT WAS 20/40 AT ONE DAY POST OP APPOINTMENT. FOLLOW UP WILL BE DONE SOON. IT WAS LEARNED THAT THERE WAS A PLANNED IRRIGATION AND ASPIRATION OF THE FOREIGN MATERIAL. NORMAL ROUTINE CATARACT PROCEDURE OCCURRED. HOWEVER, THE FOREIGN MATERIAL WILL NOT BE SENT BACK FOR EVALUATION. THE PATIENT IS DOING WELL, THERE ARE NO ISSUES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297310 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.