TECNIS IOL ZMA00 (REF ZMA00U0205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474536814), received between Nov 20, 2017 and Apr 8, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE LENS HAD SHIFTED AND DAILY ACTIVITY WAS SIGNIFICANTLY AFFECTED. A VITRECTOMY WAS NEEDED UPON LENS IMPLANTATION. INITIALLY, IT WAS STATED THAT THE PATIENT'S POST-OPERATIVE STATUS HAD IMPROVED. ADDITIONAL INFORMATION REVEALED THAT THE LENS WAS EXPLANTED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER, AND THE PATIENT HAD A YAMANE PROCEDURE WITH A LUCIA 602 LENS. FURTHER INFORMATION SUGGESTS AN ANTERIOR CAPSULAR TEAR UNDER THE INCISION, WHICH WRAPPED AROUND TO BECOME A POSTERIOR CAPSULAR TEAR. NOTICED VITREOUS COMING FROM AROUND THE POSTERIOR CAPSULE. NO MEDICAL TREATMENT IS REQUIRED. THE PRODUCT IS BEING RETUNED. THE PATIENT'S POST-OP STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 19061207 ↗
• InjuryMay 24, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE BECAUSE THE LENS BEING RIGID. REPORTEDLY, AN ANTERIOR CHAMBER INTRAOCULAR LENS WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS AN INCISION ENLARGEMENT AND VITRECTOMY PERFORMED DURING THIS PROCEDURE. VISUAL ACUITY PRE-OPERATIVE: 20/40. VISUAL ACUITY POST-OPERATIVE: CF (COUNTING FINGERS) BUT 20/70 WITH PINHOLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8642137 ↗
• InjurySep 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZMA00 20.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE LENS DISLOCATED. 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 NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7846939 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMA00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) ON (B)(6) 2010. REPORTEDLY, SINCE 2015, THE PATIENT HAS EXPERIENCED A 50% DECLINE IN HER VISION IN THE RIGHT EYE. SHE HAS ALSO EXPERIENCED VERY BAD HEADACHES, FLOATERS, AND AT TIMES WEEPING AND DRY EYES. THE PATIENT HAS GONE TO EYE DOCTORS TO GET THE MATTER RESOLVED, BUT WITH VERY LITTLE SUCCESS. IN FOLLOW UP WITH THE IMPLANTING PHYSICIAN'S OFFICE IT WAS LEARNED THE PATIENT'S LAST APPOINTMENT WITH HER SURGEON WAS (B)(6) 2017, HER BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/30+ IN BOTH EYES (OU). THE CONTACT PROVIDED THE IMPLANT DATES OF BOTH LENSES AND PRODUCT IDENTIFIERS. IN ADDITION, PER THE PATIENT'S RECORDS AT THE SURGEON'S OFFICE THERE IS NO NEED FOR ANY ADDITIONAL TREATMENT AND FOLLOW-UP WILL BE DONE AFTER 6 MONTHS. THE SURGEON DID NOT REFER THE PATIENT TO SEE A SECONDARY DOCTOR. THE PATIENT REPORTED SEEING A SECONDARY PHYSICIAN AND WAS TOLD THEY MAY NEED TO REMOVE THE LENS AND THE PATIENT REPORTEDLY HAD A FOLLOW UP APPOINTMENT WITH THIS DOCTOR ON (B)(6) 2017. IN FOLLOW UP WITH THIS SECONDARY PHYSICIAN'S OFFICE IT WAS LEARNED THE PATIENT WAS SEEN FOR A TOTALLY DIFFERENT ISSUE

  Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 7047627 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMA00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2010. REPORTEDLY, SINCE 2015, THE PATIENT HAS EXPERIENCED A MACULAR PUCKER AND HAD A VITRECTOMY PERFORMED IN THE LEFT EYE. SHE HAS ALSO EXPERIENCED VERY BAD HEADACHES, FLOATERS, AND AT TIMES WEEPING AND DRY EYES. THE PATIENT HAS GONE TO EYE DOCTORS TO GET THE MATTER RESOLVED, BUT WITH VERY LITTLE SUCCESS. IN FOLLOW UP WITH THE IMPLANTING PHYSICIAN'S OFFICE IT WAS LEARNED THE PATIENT'S LAST APPOINTMENT WITH HER SURGEON WAS (B)(6) 2017, HER BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/30+ IN BOTH EYES (OU). THE CONTACT PROVIDED THE IMPLANT DATES OF BOTH LENSES AND PRODUCT IDENTIFIERS. IN ADDITION, PER THE PATIENT'S RECORDS AT THE SURGEON'S OFFICE THERE IS NO NEED FOR ANY ADDITIONAL TREATMENT AND FOLLOW-UP WILL BE DONE AFTER 6 MONTHS. THE SURGEON DID NOT REFER THE PATIENT TO SEE A SECONDARY DOCTOR. THE PATIENT REPORTED SEEING A SECONDARY PHYSICIAN AND WAS TOLD THEY MAY NEED TO REMOVE THE LENS AND THE PATIENT REPORTEDLY HAD A FOLLOW UP APPOINTMENT WITH THIS DOCTOR ON (B)(6) 2017. IN FOLLOW UP WITH THIS SECONDARY PHYSICIAN'S OFFICE IT WAS LEARNED THE PATIENT WAS SEEN FOR A TOTALLY

  Patient problems: Dry Eye(s); Visual Disturbances; Vitrectomy

  MAUDE report 7047220 ↗