TECNIS IOL ZMA00 (REF ZMA00U0150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474536708), received between Oct 11, 2016 and Feb 21, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT A ZMA00 15.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO THE LENS BEING THE WRONG POWER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8356735 ↗
• InjuryAug 30, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZMA00 15.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. POST-OPERATIVELY, THE PATIENT HAD POOR VISUAL ACUITY AND THE LENS DISLOCATED. REPORTEDLY, THE DOCTOR PERFORMED A LENS REPOSITIONING PROCEDURE FOR THE PATIENT ON (B)(6) 2018, AND (B)(6) 2018. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018. THERE WAS NO VITRECTOMY OR SUTURES USED, BUT THERE WAS AN INCISION ENLARGEMENT. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7833940 ↗
• InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT COULD NOT TOLERATE THE HALOS AND FELT THEIR VISION WAS BLURRY. ANOTHER LENS, A LARGER DIOPTER (16.5) WAS IMPLANTED AND THAT SURGERY WENT WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6039054 ↗
• InjuryOct 11, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AFTER INJECTION OF AN INTRAOCULAR LENS, MODEL ZMA00, 15.0 DIOPTER, SURGEON WAS POSITIONING THE LENS AND THE BACK HAPTIC TORE OFF DURING THE MANIPULATION. THE LENS WAS PULLED OUT OF THE EYE AND A VITRECTOMY WAS CONDUCTED. IT WAS NOTED THAT WHEN THE HAPTIC TORE OFF, IT BECOME COMPLETELY DETACHED FROM THE OPTIC. AT THAT POINT A SECOND INTRAOCULAR LENS, MODEL ZMA00, 15.5 DIOPTER WAS OPENED AND DURING INJECTION OF THIS LENS, THE FRONT HAPTIC GOT STUCK IN THE INJECTOR AND FOLDED ON TOP OF THE OPTIC AND WAS KINKED ONCE THE LENS WAS PUSHED ALL THE WAY OUT. THIS LENS WAS THEN CUT OUT OF THE EYE AND AGAIN A VITRECTOMY WAS CONDUCTED. A REPLACEMENT LENS (14.5 DIOPTER) WAS THEN INJECTED INTO THE EYE WITH NO PROBLEM. THERE WAS NO INCISION ENLARGEMENT AND NO SUTURE WAS REQUIRED. THIS REPORT IS TO CAPTURE THE EVENT OF THE FIRST LENS USED, ZMA00 15.0 DIOPTER. A SEPARATE MDR WILL BE FILED TO CAPTURE THE EVENT RELATED TO THE SECOND LENS USED, ZMA00 15.5 DIOPTER.

  Patient problems: Vitrectomy

  MAUDE report 6019623 ↗