TECNIS IOL ZMB00 (REF ZMB00U0170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 17.0 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 05050474535565), received between May 15, 2017 and May 15, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Torn Material” (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
- Torn Material1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2017Torn Material; Torn Material
IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE AS IT WAS STUCK IN THE CARTRIDGE. THE HAPTIC TORE. THE EVENT HAPPENED DURING HANDLING BUT PRIOR TO INSERTION. IT WAS REPORTED THAT ¿THERE WAS PATIENT CONTACT BY TOUCHING THE EYE BUT NOT INSERTED¿. DURING FOLLOW UP, IT WAS LEARNED THAT THERE WAS PATIENT CONTACT WITH THE IOL, THE IOL WAS FULLY INSERTED, THE PATIENT WAS LEFT APHAKIC, THERE WAS NO VITRECTOMY, AND THERE WAS NO INCISION ENLARGEMENT OR SUTURE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Code Available
MAUDE report 6568078 ↗
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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