TECNIS IOL ZMB00 (REF ZMB00U0155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 15.5 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 05050474535534), received between Sep 12, 2018 and Sep 12, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Blurred Vision1
- 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.
InjurySep 12, 2018Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD UNSTABLE IMPLANT, WHERE THE CAPSULAR INTEGRITY OF THE PATIENT'S LEFT EYE (OS) IS NO LONGER VIABLE TO KEEP THE LENS IN POSITION. AS A RESULT, ZMB00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM PATIENT''S OS. STANDARD INCISION WAS ALSO PERFORMED TO REMOVE THE LENS AND THERE WILL BE PLANNED ANTERIOR VITRECTOMY PER FOLLOW-UP. REPORTEDLY, THE PATIENT HAD BLURRED VISION (B)(6) 2018, SO THE LENS WAS ALSO REPOSITION THEN. HOWEVER, PATIENT WAS DOING WELL POST-SURGERY AS THERE WAS NO PATIENT INJURY. PRODUCT IS EXPECTED TO RETURN. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 7868967 ↗
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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