TECNIS IOL ZMA00 (REF ZMA00U0250)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 25.0 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474536906), received between Aug 25, 2017 and Aug 31, 2018 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 reports).
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
- Difficult or Delayed Positioning2
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Information2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A ZMA00 25.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. ONE DAY POST-OP, ON (B)(6) 2018, A POWER MISS/REFRACTIVE ERROR OF -1.00 DIOPTER MYOPIA WAS OBSERVED; ALSO POOR UNCORRECTED DISTANCE VISION WAS NOTED. THEREFORE, THE LENS WAS EXPLANTED ON (B)(6) 2018. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 24.0. REPORTEDLY, THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7837039 ↗MalfunctionAug 25, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning
WHEN INSERTING THE INTRAOCULAR LENS (IOL) INTO THE EYE, THE CUSTOMER ACCOUNT REPORTED THAT THE IOL WAS STUCK IN THE PLUNGER/CARTRIDGE AND THERE WAS PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Information
MAUDE report 6819684 ↗MalfunctionAug 25, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning
WHEN INSERTING THE INTRAOCULAR LENS (IOL) INTO THE EYE, THE CUSTOMER ACCOUNT REPORTED THAT THE IOL WAS STUCK IN THE CARTRIDGE AND THERE WAS PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Information
MAUDE report 6819683 ↗
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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