TECNIS IOL ZMA00 (REF ZMA00U0175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474536753), received between Mar 13, 2019 and Apr 24, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2022Adverse 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 FROM THE RIGHT EYE BECAUSE THE PATIENT WAS UNHAPPY WITH THE RESULTS. A COMPETITOR IOL WAS IMPLANTED AS REPLACEMENT (SAME DIOPTER). THERE WAS NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. IT IS UNKNOWN HOW THE PATIENT IS DOING POST-OPERATIVELY. THE EXPLANTED IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191156 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT THE IMPLANTED INTRAOCULAR LENS (IOL) IN HER LEFT EYE DOES NOT WORK AS SHE THOUGHT IT WOULD. THE PATIENT INDICATED THAT SOMETHING WENT WRONG WHEN THE LENS WAS BEING INSERTED WHICH THE IOL SLIPPED AND WAS NOT PLACED PROPERLY. THE PATIENT CONTINUES TO HAVE SWELLING IN THAT EYE WHICH SHE IS SEEING A SPECIALIST FOR IT. THE PATIENT¿S MAIN COMPLAINT IS THAT SHE NEEDS TO WEAR GLASSES FOR NEAR AND FAR. REPORTEDLY, THE PATIENT¿S RETINA STILL HAS SWELLING/INFLAMMATION. THE PATIENT HAS BEEN USING OPHTHALMIC DROPS (COMBIGAN, DORZOLAMIDE AND PRED-G) TWICE/DAY FOR THE PAST FIVE MONTHS. IT WAS INDICATED THAT SHE HAD TO HAVE AN EMERGENCY SURGERY AFTER HER CATARACT SURGERY BUT NO DETAILS WERE PROVIDED. THE PATIENT HAS CLOUDY VISION AND HER NEAR AND DISTANCE VISIONS ARE NOT GOOD. THE PATIENT STILL HAS TO WEAR GLASSES. THE PATIENT STATED THAT SHE HAS HAD HIGH INTRAOCULAR PRESSURE (IOP) AND AT THE PRESENT, HER IOP IS 18 WITH MEDICATION. THE PATIENT HAS NOT SEEN ANY IMPROVEMENTS AND HAS BEEN SEEING A RETINA SPECIALIST. THE PATIENT¿S NEXT APPOINTMENT IS ON (B)(6) 2021. THE PATIENT IS GOING TO ASK FOR STRONGER MEDICATIONS AS SHE IS FRUSTRATED BECAUSE HER DOCTOR CANNOT TAKE O

  Patient problems: Blurred Vision; Halo; Inflammation; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment

  MAUDE report 11817558 ↗
• InjuryMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED BECAUSE IT SUBLUXED POST-OPERATIVELY. REPORTEDLY, THERE WAS A VITRECTOMY PERFORMED, BUT NO INCISION ENLARGEMENT REQUIRED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT A HIGHER DIOPTER (20.5). THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT IS NOTED TO BE FINE POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8419030 ↗