TECNIS IOL ZMB00 (REF ZMB00U0160)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 16.0 US · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474535541), received between Jan 18, 2017 and Jan 18, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- Blurred Vision1
- Inflammation1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
A PATIENT CONTACTED AMO TO REPORT THAT HE EXPERIENCED SWELLING AND THAT THE LENS DOES NOT SEEM TO BE CENTERED. THE PATIENT SAW HIS DOCTOR WHO INFORMED HIM HE HAD INFLAMMATION FOLLOWING IMPLANT OF THE INTRAOCULAR LENS (IOL) IN HIS LEFT EYE. THE DOCTOR PRESCRIBED DUREZOL 4 TIMES PER DAY FOR A WEEK AND HAD TAKEN THE PATIENT OFF OF TWO OTHER MEDICATIONS. THE PATIENT HAD EXPERIENCED BLURRY VISION AND DURING A VISIT WITH THE DOCTOR, WAS TOLD BY THE DOCTOR THAT THE LENS HAD MOVED AND WAS MAYBE DUE TO INFLAMMATION. THE DOCTOR CHOSE TO TAKE A WAIT AND SEE APPROACH BEFORE DETERMINING IF A RE-CENTERING OF THE LENS WAS NEEDED. FURTHER INFORMATION WAS RECEIVED FROM THE PATIENT WHO REPORTS THAT HE IS SEEING BETTER THAN EVER AND NO LONGER HAS ISSUES WITH HIS VISION. EVERYTHING WAS FEELING BETTER ON (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Inflammation; Swelling
MAUDE report 6259265 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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