TECNIS IOL ZMA00 (REF ZMA00U0155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474536715), received between Oct 11, 2016 and Feb 21, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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, 2020Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF BLURRY VISION, SEEING A BLUE RING AROUND OBJECTS, AND POOR NEAR VISION. DURING A FOLLOW UP VISIT ON (B)(6) 2020, IT WAS OBSERVED THAT THE INTRAOCULAR LENS (IOL) HAD DISLOCATED AND WAS OUT OF THE VISUAL AXIS. THE LENS WAS REPOSITIONED THE FOLLOWING DAY. ON (B)(6) 2020 THE LENS HAD DISLOCATED AGAIN, THEREFORE, THE LENS WAS EXPLANTED THEN DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 9738759 ↗
• InjuryMar 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZMA00 +15.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF DECENTERED LENS. THERE WAS NO PATIENT INJURY, NO VITRECTOMY, NO INCISION ENLARGEMENT REQUIRED. LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS HAPPY WITH VISION POST OPERATIVELY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8454814 ↗
• InjuryOct 26, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZMA00 INTRAOCULAR LENS (IOL) WAS REMOVED/EXPLANTED FROM A MALE PATIENT'S LEFT (OS) EYE AS IT WAS DECENTERED. IT WAS NOTED THAT THE LENS WAS DECENTERED THE WEEK OF (B)(6) 2016, AND THE DOCTOR CENTERED THE IOL. THE IOL BECAME DECENTERED AGAIN THE FOLLOWING WEEK AND THE PATIENT GOT DOUBLE VISION. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2016, THE IOL WAS REMOVED AND ANOTHER MANUFACTURER'S LENS WAS IMPLANTED AS A REPLACEMENT. IT WAS NOTED THAT THE REASON FOR THE IOL DECENTRATION WAS UNKNOWN. THERE WERE NO INCISION ENLARGEMENT, VITRECTOMY AND/OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY POST-OP REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6059395 ↗
• InjuryOct 11, 2016Difficult or Delayed Positioning; Kinked; Difficult or Delayed Positioning; Kinked

  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 SECOND LENS USED, ZMA00 15.5 DIOPTER. A SEPARATE MDR WILL BE FILED TO CAPTURE THE EVENT RELATED TO THE FIRST LENS USED, ZMA00 15.0 DIOPTER.

  Patient problems: Vitrectomy

  MAUDE report 6019608 ↗