TECNIS IOL ZMB00 (REF ZMB00U0240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474535701), received between Sep 2, 2016 and Jan 2, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT AFTER THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT EXPERIENCED DIFFICULTY WITH BOTH DISTANCE AND NEAR VISION, STATING THAT THE LENS HAD NOT PERFORMED WELL. IN 2017, THE PATIENT DEVELOPED A 'FILM' IN THE LEFT EYE, WHICH WAS TREATED WITH LASER, RESULTING IN IMPROVED VISION. LATER, THE PATIENT EXPERIENCED A 'BUBBLE' IN THE LEFT EYE THAT RESOLVED ON ITS OWN. RECENTLY, THE PATIENT'S VISION WORSENED SIGNIFICANTLY, AND DURING A VISION TEST, WAS UNABLE TO SEE THE TOP LINE OF THE CHART. THE PATIENT WAS DIAGNOSED WITH DRY EYE AND WAS RECOMMENDED GLASSES; HOWEVER, THE PATIENT WAS CONCERNED THAT THE IOL MIGHT BE FAULTY, AS THE PATIENT WAS INFORMED THAT THERE WERE NO OTHER ISSUES WITH THE EYE DESPITE THE WORSENING VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Deposits; Dry Eye(s); Posterior Capsule Opacification; Unspecified Eye / Vision Problem

  MAUDE report 23944226 ↗
• InjuryApr 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT SHE HAD 20/20 VISION RIGHT AFTER SURGERY ON HER LEFT EYE (OS). HOWEVER, LATELY SHE NOTICED THAT HER VISION IS GETTING WORSE AND WORSE, SHE NEEDS TO PUT THINGS RIGHT NEXT TO HER FACE TO READ THE ITEM. THE PATIENT HAS EYE PAIN SPORADICALLY AND GETS A SHARP PAIN IN HER EYE OFF AND ON WHICH STARTED LAST YEAR. HER DOCTOR RECOMMENDED TO THE PATIENT TO SEE AN EYE SPECIALIST FOR A ROUTINE EYE EXAM. ON (B)(6) 2020, THE PATIENT INDICATED THAT SHE IS STILL NOT ABLE TO SEE NEAR OR FAR WELL AND HER VISION IS BLURRY, NOT CLEAR. THE PATIENT NOTED THAT THE LENS WAS TO CORRECT HER FAR AND NEAR VISION. REPORTEDLY, THE PATIENT¿S PROBLEM WITH THE LEFT EYE STARTED ABOUT 5-6 MONTHS AGO, SHE NOTICED HER VISION IS NOT AS GOOD, NOT CLEAR AS IT USED TO BE. THE PATIENT WAS GIVEN READERS BUT SHE STILL HAS ISSUES WITH THIS EYE. THE PATIENT CANNOT RECOGNIZE PEOPLE EVEN WITH THE READERS, UNLESS THEY ARE WITHIN 12 FEET DISTANCE FROM HER. RECENTLY, THE PATIENT WAS REFERRED TO A SPECIALIST WHO INDICATED THAT THERE WAS NO ISSUE WITH THE LENS. THE SPECIALIST ASKED THE PATIENT TO RETURN IN TWO WEEKS AND THEY COULD SUCTION OUT THE CLOUDY PART/THE FILM UNDERNEATH THE LENS. NO CLARIFICATION

  Patient problems: Blurred Vision; Pain; Visual Impairment

  MAUDE report 9999017 ↗
• InjuryJan 31, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED, FROM THE PATIENT'S RIGHT EYE, DUE TO UNEXPECTED POST OP REFRACTION. THE LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER 22.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED.

  Patient problems: No Code Available

  MAUDE report 6288794 ↗
• InjurySep 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A ZMB00 MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT EYE, HAS HAD IT REMOVED BY A DIFFERENT SURGEON THAN THE REPORTING SURGEON. THE PATIENT VISITED THE SURGEON WHO PERFORMED THE EXPLANT ON A NUMBER OF OCCASIONS FOLLOWING THE IMPLANT AND AT EACH VISIT THE COMPLAINT WAS BLURRED VISION, HALOS, GLARE, LIGHT SENSITIVITY AND INABILITY TO DRIVE. THE PATIENT'S VISUAL ACUITY PRE-OP (INITIAL IMPLANT) WAS 20/30. HER VISUAL ACUITY POST-OP (INITIAL IMPLANT) WAS 20/80. THE EXPLANTED LENS (ZMB00) WAS REPLACED WITH A MODEL PCB00 (23.5 DIOPTER) IOL. THE PATIENT IS DOING WELL AFTER THE REPLACEMENT PROCEDURE; VISUAL ACUITY IS 20/20 UNCORRECTED. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED DURING THE REPLACEMENT PROCEDURE. THERE WAS NO LENS ROTATION NOTICED PRIOR TO THE EXPLANT. NO TREATMENTS OR PRESCRIPTIONS WERE GIVEN BY THE SURGEON WHO PERFORMED THE REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 5926268 ↗