TECNIS IOL ZMA00 (REF ZMA00U0200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474536807), received between Nov 7, 2016 and Aug 15, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZMA00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. INFORMATION ABOUT THE REPLACEMENT IOL INFORMATION IS UNKNOWN. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, SERIOUS PATIENT INJURY, SUTURES, AND VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS LENS EXCHANGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19992837 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO PATIENT HAVING VISUAL GHOSTING ISSUES. THE SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT IS NOTED TO BE DOING ALRIGHT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11586569 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT THAT A ZMA00, 20.0 DIOPTER LENS WAS INSERTED IN THE PATIENT¿S OPERATIVE EYE. THE PATIENT¿S ANATOMY WOULD NOT HOLD THE IOL. THE LENS WAS REMOVED, AND NO REPLACEMENT LENS WAS IMPLANTED. A VITRECTOMY WAS PERFORMED. REPORTEDLY THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8931552 ↗
• InjuryMar 6, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZMA00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATENT'S RIGHT EYE (OD) DUE TO A SUBLUXATION OF THE LENS. THROUGH FOLLOW UP IT WAS CONFIRMED THAT THE PATIENT WAS EXPERIENCING SUBLUXATION OF THE LENS OD (DECENTERED SUPEROTEMPORAL). PATIENT ALSO EXPERIENCE PAIN, FOREIGN BODY SENSATION, BLURRY VISION, LIGHT SENSITIVITY AND HALOS ON HER RIGHT EYE. THESE ISSUES HAVE AFFECTED HER DAILY ACTIVITIES. VISUAL ACUITY RIGHT EYE: SC 20/50 (SANS CORRECTED) PH 20/40 (PIN HOLE). VISUAL ACUITY LEFT EYE: SC 20/50 PHNI (PIN HOLE NO IMPROVEMENT).

  Patient problems: Blurred Vision; Halo; Pain

  MAUDE report 6382491 ↗
• InjuryDec 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMA00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT VISION NOT BEING GREAT. IT WAS REPORTED THAT THE PATIENT WAS ALSO EXPERIENCING GLARES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6155500 ↗
• InjuryNov 7, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS IT WAS NOT CENTERING PROPERLY AND WAS LIKELY DUE TO A CRIMPED OR DAMAGED HAPTIC. ANOTHER LENS, SAME MODEL WAS IMPLANTED AND THE PATIENT WAS REPORTED DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6084438 ↗