TECNIS IOL ZMB00 (REF ZMB00U0175)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 17.5 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 05050474535572), received between May 2, 2017 and May 2, 2017 — classified as 1 injury.
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
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 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FAILED CATARACT SURGERY LEFT A PATIENT WITH EXTREME DOUBLE VISION. THROUGH FOLLOW UP IT WAS LEARNED THAT INITIALLY, A ZMB00 17.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2014, IN THE PATIENT'S RIGHT EYE. AFTER THE IMPLANT THE PATIENT EXPERIENCED DOUBLE VISION. ON (B)(6) 2014, THE PHYSICIAN PIGGY-BACKED AN AR40M 1.0 INTRAOCULAR LENS. THIS WAS NO HELP AS THE PATIENT CONTINUED TO EXPERIENCE DOUBLE VISION. THE PHYSICIAN WILL BE FITTING THE PATIENT WITH AN EXTENDED WEAR (30 DAY) CONTACT LENS TO SEE IF THAT RESOLVES THE DOUBLE VISION. THERE HAVE BEEN NO OTHER SECONDARY MEDICAL OR SURGICAL PROCEDURES. NO INJURIES OR ISSUES OTHER THAN THE DOUBLE VISION. THE LENSES ARE STILL IMPLANTED AND THERE ARE NO PLANS TO EXPLANT AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE ZMB00 IOL IMPLANTED ON (B)(6) 2014. A SEPARATE MDR WILL BE FILED FOR THE AR40M DEVICE.
Patient problems: No Code Available
MAUDE report 6539269 ↗
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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