TECNIS IOL ZMB00 (REF ZMB00U0220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474535664), received between Dec 2, 2016 and Oct 11, 2019 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZMB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE DUE TO POWER DISCREPANCY-UNEXPECTED POST-OP REFRACTION, AND BLURRY VISION. PER THE CUSTOMER, THERE WAS NOTHING WRONG WITH THE EXPLANTED IOL. THE IOL WAS REPLACED WITH THE SAME MODEL LENS BUT LOWER DIOPTER (19.5). THE FOLLOWING VISUAL ACUITY MEASUREMENTS WERE PROVIDED. VISUAL ACUITY PRE-OPERATIVE: 20/70 UNCORRECTED. VISUAL ACUITY POST-OPERATIVE: 20/50 UNCORRECTED DAY 1 POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9182789 ↗
• 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 DUE TO VISUAL DISTURBANCE FROM THE PATIENT'S RIGHT EYE. IT WAS NOTED THAT THE INCIDENT WAS OBSERVED AFTER INSERTION OF THE EXPLANTED LENS. THE LENS WAS REPLACED WITH ANOTHER ZMB00 IOL, A DIFFERENT DIOPTER POWER. IT WAS STATED THAT THE PATIENT HAS RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8881508 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2015. IT WAS LATER EXPLANTED ON (B)(6) 2019, BECAUSE THE PATIENT WAS UNABLE TO ACCOMMODATE THE MULTIFOCAL LENS. THERE WAS A VITRECTOMY REQUIRED AND THE INCISION WAS ENLARGED. THE REPLACEMENT WAS A NON-JJSV LENS. PATIENT OUTCOME WAS NOTED AS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 8589079 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WAS EXPERIENCING VISUAL DISTURBANCE AND DRY EYES AFTER BILATERAL IMPLANTATION OF A ZMB00 INTRAOCULAR LENSES. SHE REGRETS HAVING GONE THROUGH CATARACT SURGERY AT THE END OF 2014 SINCE SHE ENDED UP WEARING PRESCRIPTION GLASSES FOR BOTH EYES (OU). SHE WAS ALSO UNABLE TO DRIVE AT NIGHT AS STREET LIGHTS AND AUTOMOBILE LIGHTS CREATE HALOS THAT INTERFERE WITH HER SEEING WELL. HER VISION ISSUES HAVE NOT IMPROVED. THROUGH FOLLOW-UP, THE PATIENT CONFIRMED THAT HER EYES ARE SENSITIVE TO LIGHT. SHE MUST WEAR SUNGLASSES ALL THE TIME AS EVERYTHING IS TOO BRIGHT FOR HER EYES. SHE DRIVES DURING THE DAY WITH SUNGLASSES, BUT SHE DOESN'T DRIVE AT NIGHT BECAUSE OF THE HALOS. SHE DIDN'T START NOTICING HER SYMPTOMS UNTIL AFTER THE SECOND LENS (RIGHT EYE) WAS IMPLANTED. SHE DOES NOT REMEMBER THE EXACT DATE WHEN SHE NOTICED ANY OF THE VISION CHANGES. HER EYES BECAME DRY, SO SHE WAS USING EYE DROPS SHORTLY AFTER. THE DOCTOR DID PERFORM A LASER PROCEDURE, BUT SHE DOES NOT REMEMBER WHAT KIND OF LASER, AND IT DID NOT HELP WITH HER VISION. THERE ARE NO PLANS TO REMOVE OR REPLACE THE LENS. SHE IS NOT HAPPY WITH THE OUTCOME. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PE

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

  MAUDE report 8303692 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD EXTREME BLURRED VISION AND HALOS AFTER IMPLANTING THE ZMB00 +22.0 DIOPTER MULTIFOCAL IOL (INTRAOCULAR LENS). AS A RESULT, IOL HAD TO BE EXPLANTED AND REPLACED WITH MODEL ZA9003 +21.5 DIOPTER MONOFOCAL IOL. VITRECTOMY WAS NOT PERFORMED, BUT THE INCISION WAS ENLARGED AND SUTURE WAS REQUIRED. THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED AND IN STABLE CONDITION. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/50. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/40 2-MONTH POST-OP. VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/50 1-DAY POST-OP. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 7973372 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZMB00 +22.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +21.0 DIOPTER) WAS IMPLANTED AS THE REPLACEMENT LENS. THE PATIENT WAS REPORTED TO BE DOING WELL AT DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7308790 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A TECNIS 1 MULTIFOCAL (TMF) MODEL ZMB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S OPERATIVE EYE AS THERE WERE NIGHT DRIVING COMPLAINTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6526999 ↗
• 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 FIRST OF TWO LENS IMPLANTS.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 6232191 ↗
• InjuryDec 2, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZMB00 INTRAOCULAR LENS (IOL) IS PLANNED TO BE EXPLANTED DUE TO A PATIENT COMPLAINING OF GHOSTING, 1 WEEK POST-OP. THE PHYSICIAN ALSO NOTICE WHAT SEEMS TO BE LIKE A DRILL HOLE ON ONE OF THE DIFFRACTIVE RINGS ON THE MULTIFOCAL LENS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6142238 ↗