TECNIS IOL ZMA00 (REF ZMA00U0165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474536739), received between Dec 10, 2023 and Dec 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryDec 10, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT WHO DEVELOPED DOUBLE VISION FROM A DEFECT ON THE OPTIC (LOOKS LIKE A SCRATCH MAYBE LOADING) AND A WONKY HAPTIC. THE DOCTOR NOTED THAT HE NEEDS TO EXCHANGE. IT WAS STATED THAT THE LENS IMPLANTED IS A +16.5 BUT THE PATIENT WAS HYPEROPIC AND IOL WAS DECENTERED. FURTHER CLARIFICATION NOTED THAT THE DOCTOR THOUGHT ABOUT EXCHANGE FROM THE START BUT HE TRIED TO REPOSITION THE LENS AND RECHECKED OCULAR RESPONSE ANALYZER (ORA) WHICH SHOWED PLANO WITH THE IOL IN PLACE SO HE THOUGHT IT WAS GOOD. BUT THE PATIENT STILL MEASURES +1.00 TO +1.25 IN THE REAL WORLD EVEN SINCE HIS FIRST SURGERY. THE DOCTOR WAS GOING TO DO LASIK BUT HE CANNOT GET THE DOUBLE IMAGE TO GO AWAY EVEN IN A CONTACT LENS SO THE LENS WOULD NEED TO COME OUT ANYWAY. IT WAS NOTED LATER ON THAT EXPLANT OF IOL OCCURRED. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO COMPLICATIONS. THE REPLACEMENT LENS USED WAS SAME MODEL BUT 1.0 DIOPTER POWER SIZE HIGHER THAN THE ORIGINAL IO. THIS REPLACEMENT IOL HELPED ADDRESS THE VISUAL ISSUES OF THE PATIENT. PATIENT TOLERATED THE PROCEDURE WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 18298386 ↗