TECNIS IOL ZMB00 (REF ZMB00U0135)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 13.5 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 05050474535497), received between May 5, 2017 and Aug 5, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Incorrect Measurement” (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
- Incorrect Measurement1
Patient problems
- No Code Available2
- Halo1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2020Incorrect Measurement; Incorrect Measurement
THE SURGERY CENTER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE PATIENT'S RIGHT EYE (OD) AS THE LENS WAS THE WRONG SIZE. A REPLACEMENT LENS OF THE SAME MODEL, BUT LOWER DIOPTER (11.5) WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 10370878 ↗InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT AN EXPLANT OF A MODEL ZMB00 (13.5 DIOPTER) INTRAOCULAR LENS (IOL) WAS PERFORMED ON THE RIGHT EYE (OD) OF A FEMALE PATIENT BECAUSE OF MECHANICAL FAILURE. A VITRECTOMY AND NEW INCISION WERE REQUIRED. THE LEADING HAPTIC WAS AMPUTATED AND THE OPTIC WAS BISECTED. THE LENS WAS REMOVED IN TWO PIECES. THERE WAS NO SUTURE REQUIRED AND NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP IT WAS CLARIFIED THAT THE REPORTED MECHANICAL FAILURE WAS THAT THE PATIENT EXPERIENCED BAD HALOS AND GLARE WITH THE LENS. THE NEW INCISION WAS DONE DUE TO THE LENS BEING IMPLANTED IN THE PATIENT'S EYE FOR THREE (3) YEARS SO NEW INCISION WAS MADE TO GET THE LENS OUT. THE VITRECTOMY WAS BECAUSE OF REMOVING THE LENS AND THE PATIENT HAD PREVIOUSLY HAD A YAG CAPSULOTOMY.
Patient problems: Halo; No Code Available; Vitrectomy
MAUDE report 6549543 ↗
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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