TECNIS IOL ZMA00 (REF ZMA00U0190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474536784), received between Jun 7, 2018 and Oct 29, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL LENS WAS EXPLANTED DUE TO THE PATIENT'S COMPLAINT OF SEVERE GLARE AND WAS REPLACED WITH AN AR40 LENS DURING A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT HAD LASIK EYE SURGERY 20 YEARS AGO (IN 2005). ON (B)(6) 2024, THE SURGEON PERFORMED A YAG CAPSULOTOMY IN THE EYE, BUT IT DID NOT PROVIDE RELIEF. THE PATIENT IS SATISFIED WITH THE REDUCTION IN GLARE SYMPTOMS FOLLOWING THE EXPLANT. NO INJURIES OR MEDICAL INTERVENTIONS ARE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 20562404 ↗
• InjuryJun 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING BLURRED VISION WITH A MULTIFOCAL INTRAOCULAR LENS (IOL) IN THE LEFT EYE. VISUAL ACUITY (VA) 20/80 TO 20/50 WITH DISTORTION, VISION NEVER IMPROVED AND LENS DISLOCATED. THE PATIENT WAS SEEN BY ANOTHER DOCTOR WHO FEELS IT WOULD BE BEST TO EXCHANGE THE LENS; HOWEVER, THE LENS HAS NOT YET BEEN EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19630552 ↗
• InjuryNov 5, 2020Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, REMOVED AND REPLACED DUE TO BENT HAPTIC. THERE WAS AN INCISION ENLARGEMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE DIFFERENT LENS MTA4UO. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10796407 ↗
• InjuryJun 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR NOTICED THAT FOUR (4) PATIENTS HAD INCREASED INFLAMMATION POST-OP. THE DOCTOR STATED HE WAS THINKING IT WAS DUE TO TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE DOCTOR DID HIS OWN DUE DILIGENCE TO SEE IF THERE WAS A TREND. HE REVIEWED THE SURGERIES TO INCLUDE ANY PROCEDURAL CHANGES, PRODUCT CHANGES OR OPERATING ROOM CHANGES. NOTHING WAS FOUND TO BE DIFFERENT. LAB CULTURES WERE NOT PERFORMED, NOR ANY TESTING FOR TASS. THE PATIENTS HAD INCREASED INFLAMMATION THAT DID NOT SUBSIDE, AND A PATIENT ALSO HAD CORNEAL EDEMA. THE DOCTOR TREATED THE PATIENTS WITH INCREASED POST-OP MEDICATION WITH A CHANGE IN DOSAGE FROM THE USUAL FREQUENTLY TO EVERY HOUR INSTEAD. PATIENTS WERE PRESCRIBED OFLOXACIN (ANTIBIOTIC), PREDNISOLONE, AND KETOROLAC (COMBINATION ANTIBIOTIC, ANTI-INFLAMMATORY AND STEROID). THE DOCTOR NOTICED THE PATIENT¿S SYMPTOMS WERE SUBSIDING. NO PLAN TO REMOVE ANY OF THE LENSES AND THUS FAR, ALL PATIENTS WERE OK. THIS MDR REPORT PERTAINS TO THE ONE OF FOUR EVENTS. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENSES.

  Patient problems: Corneal Edema; Endophthalmitis; Inflammation

  MAUDE report 8746754 ↗
• InjuryDec 28, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE DOCTOR HAS A PATIENT THAT WAS NOT SEEING CLEARLY AFTER CATARACT SURGERY AFTER IMPLANTING A ZMA00 INTRAOCULAR LENS (IOL) FOR REASONS THAT SEEMED LIKE A TYPICAL YTTRIUM ALUMINUM GARNET (YAG) LASER WOULD SOLVE. AFTER YAGGING THE CAPSULE, THE PATIENT¿S VISION DID NOT CHANGE MUCH. THE DOCTOR INDICATED THAT IT SEEMS LIKE A POSTERIOR CAPSULAR OPACITY (PCO) MEMBRANE BUT IT IS ON THE POSTERIOR SURFACE OF LENS. THE VISUAL ACUITY REPORTED IS 20/25 + BUT NOT CLEAR LIKE NEW LENS. IT WAS NOTED THAT NO EXPLANT IS NECESSARY.

  Patient problems: Visual Impairment

  MAUDE report 8205012 ↗
• InjuryJun 7, 2018Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZMA00 19.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. POST-OPERATIVELY, ON (B)(6) 2018, A LENS REPOSITIONING PROCEDURE WAS PERFORMED, BUT UPON TRYING TO REPOSITION THE LENS, THE DOCTOR NOTICED THAT THE HAPTIC OF THE LENS HAD A CRIMP IN IT. THEREFORE, THE LENS WAS EXPLANTED FROM THE OPERATIVE EYE AND THE REPLACEMENT LENS WAS THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7577292 ↗