TECNIS IOL ZMB00 (REF ZMB00U0235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 23.5 US · 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 05050474535695), received between Sep 11, 2016 and Oct 3, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Split, Cut or Torn1
Patient problems
- No Code Available2
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2018Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
IT WAS REPORTED THAT MODEL ZMB00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS) FELL APART IN PATIENT'S EYE AND HAD TO BE REMOVED IN PIECES. AN INCISION ENLARGEMENT WAS PERFORMED. THE DOCTOR REPLACED IT WITH THE SAME SIZE AND MODEL LENS. THERE WAS NO DAMAGE NOR INJURY TO THE PATIENT'S EYE. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 7930321 ↗InjurySep 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON PERFORMED AN EXPLANT OF A MODEL ZMB00 INTRAOCULAR LENS DUE TO DYSPHOTOPSIA. THE REPLACEMENT LENS USED WAS FROM ANOTHER MANUFACTURER, +23.5 DIOPTER. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 5942102 ↗
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 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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