TECNIS IOL ZMA00 (REF ZMA00U0310)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 31.0 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474537026), received between Feb 4, 2018 and Feb 4, 2018 — classified as 1 malfunction.
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
- Corneal Edema1
- 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.
MalfunctionFeb 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZMA00 31.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INCORRECTLY CHOSEN AND GIVEN TO THE DOCTOR, AND THEN IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, THE DOCTOR EXPLANTED THE INCORRECT LENS ON (B)(6) 2018 AND REPLACED IT WITH THE CORRECT LENS, WHICH WAS A ZMA00 20.5 DIOPTER LENS. THERE WAS A SLIGHT INCISION ENLARGEMENT, BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. THE PATIENT WAS SEEN POST-OPERATIVELY ON (B)(6) 2018 AND THE PATIENT'S UNAIDED VISUAL ACUITY WAS 20/40-2 WITH SOME EDEMA. THE EXPLANTED LENS WAS DISCARDED. REPORTEDLY, THE PATIENT'S NEXT FOLLOW UP APPOINTMENT WILL BE ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Corneal Edema; No Code Available
MAUDE report 7240257 ↗
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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