TECNIS IOL ZMB00 (REF ZMB00U0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474535657), received between Aug 24, 2016 and Aug 9, 2019 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO PATIENT DEVELOPING VISUAL DISTURBANCES. IT WAS STATED THAT THE VISUAL DISTURBANCE SIGNIFICANTLY INTERFERED WITH THE PATIENT¿S REGULAR DAILY ACTIVITIES. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER ZMB00 OF A DIFFERENT DIOPTER POWER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT WAS NOTED TO HAVE RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8881504 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANT THE PATIENT¿S VISUAL ACUITY IS LOWER THAN EXPECTED. SURGEON STATES THE PATIENT¿S REFRACTION IS +0.50 AT 10 DEGREE FOUR MONTHS POST-OPERATIVELY, SO HE DECIDED TO IMPLANT A PIGGY BACK MODEL AR40M +1.5 DIOPTER AFTER CALCULATING WITH A BARRETT CALCULATOR. AT IMPLANT OF THE PIGGYBACK LENS THE INCISION WAS ENLARGED TO 2.75. ADDITIONAL INFORMATION STATES THERE WAS CORNEAL EDEMA POST-OP OF THE PIGGY BACK LENS, VISUAL ACUITY WAS NOT AVAILABLE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 8829453 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT SHE WAS IMPLANTED WITH A MODEL ZMB00 INTRAOCULAR LENS (IOL) IN EACH EYE. SHE WANTED TO KNOW IF WE HAD ANY REPORTS OF LENSES LOSING POTENCY AFTER A FEW YEARS. THE LENSES WERE IMPLANTED ABOUT 4 YEARS AGO, HER EYES HAVE BEEN RED AND SWOLLEN ADDITIONALLY, SHE CANNOT SEE AS WELL AS SHE USED TO. SHE HAS SEEN HER DOCTOR ABOUT THESE ISSUES. THROUGH FOLLOW-UP WITH THE PATIENT IT WAS LEARNED HER VISION WAS OKAY UNTIL ABOUT 6 MONTHS WHEN HER VISUAL ISSUES OF NOT SEEING WELL STARTED. RECENTLY, SOMETHING IS WRONG WITH HER RETINA (SHE REPORTS SHE HEARD WRINKLE IN RETINA) AND SHE IS SEEING A RETINA SPECIALIST. FOLLOW-UP WITH THE PHYSICIAN¿S OFFICE CONFIRMED THAT THE PATIENT WAS JUST IN THE CLINIC A FEW DAYS AGO FOR FOLLOW-UP. THE CONTACT PERSON PROVIDED PRODUCT IDENTIFIERS AS WELL AS IMPLANT DATES FOR EACH IOL. SHE ADDED THAT IN THE PATIENT¿S CHART, IT IS NOTED THE PATIENT HAS GLAUCOMA, MACULAR PUCKER, DRY EYE, AND IS SEEING A RETINA SPECIALIST. THE CHART ALSO INDICATED THAT IN (B)(6) 2014, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 BOTH EYES (OU) BUT THEN IN HER RECENT VISIT HER BCVA WAS 20/50 FOR THE LEFT EYE (OS) AND 20/30 FOR THE RIGHT (OD). THE

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

  MAUDE report 8337510 ↗
• InjuryJun 14, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZMB00 21.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT DIDN'T GET GOOD VISION CORRECTION. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 23.5. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7599847 ↗
• InjuryJan 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY HAVE A PATIENT WHO IS NOT HAPPY WITH HER SURGERY. FURTHER INFORMATION REPORTED THE PATIENT UNDERWENT SURGERY ON BOTH EYES, (B)(6) 2016, THE EXACT IMPLANT DATES WERE NOT PROVIDED. THE ONSET DATE OF THE PATIENT'S SYMPTOMS WAS NOT PROVIDED. THE PATIENT CAN NOT SEE UP CLOSE, WITHIN 6 INCHES. REFOCUSING IS DIFFICULT, SUCH AS THE FOCUS FROM THE COMPUTER SCREEN TO THE KEYBOARD AND BACK TO THE COMPUTER SCREEN. GLARE AT NIGHTS MAKES IF DIFFICULT TO JUDGE DISTANCE; DIFFICULT TO DRIVE. BEFORE SURGERY THERE WERE NO FOCUS ISSUES AND ONLY SLIGHT HALOS DUE TO THE CATARACTS. WHEN THE PATIENT STARES AT LETTERS, THE LETTERS MOVE/SHAKE. VISION ON THE DAY AFTER SURGERY WAS 20/30 AND IS NOW 20/50. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD TWO LENSES IMPLANTED; THEREFORE, REPORTING ON BOTH LENSES. THIS REPORT REPRESENTS THE SECOND OF TWO LENS IMPLANTS.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 6232192 ↗
• InjuryAug 24, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZMB00 INTRAOCULAR LENS (IOL) WAS CUT OUT AS IT WOULD NOT CENTER IN THE LEFT EYE. REPORTEDLY, THE SUSPECT ZMB00 LENS WAS REPLACED WITH A 3-PIECE SULCUS LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES OR OTHER PATIENT INJURY. PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5901566 ↗