TECNIS IOL ZMA00 (REF ZMA00U0160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474536722), received between May 4, 2019 and May 4, 2019 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2019Unintended Movement; Unintended Movement

  THE PATIENT REPORTED THAT HE HAD A MULTIFOCAL LENS INSERTED IN HIS RIGHT (OD) EYE FIRST (UNKNOWN MANUFACTURER). AFTER 2 WEEKS, HE RUBBED HIS EYE AND CAUSED THE LENS TO ROTATE. THE SURGEON ATTEMPTED TO REPOSITION IT A FEW TIMES BUT WAS NOT SUCCESSFUL. THE SURGEON THEN REPLACED THE ORIGINAL LENS WITH THIS LENS (ZMA) ON (B)(6) 2019. PATIENT SAID THAT TWO DAYS POST-OP, HE STARTED TO SEE DOUBLE. IT SEEMED THAT IT WAS ALWAYS AT THE LEFT LOWER CORNER WHERE THE IMAGES BECAME MOST BLURRY. HE VISITED THE SURGEON ABOUT A WEEK AGO ((B)(6) 2019) AND COMPLAINED THAT HIS VISION HAS NOT IMPROVED. THE SURGEON TRIED TO ADJUST THE LENS, BUT IT WOULD NOT CENTER. THE SURGEON ASKED THAT THE PATIENT TO GIVE IT SOME TIME TO ADJUST. THE SURGEON ALSO INDICATED A MONOFOCAL ANTERIOR LENS MAY WORK IF THE PATIENT REQUIRES A LENS EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8580800 ↗