TECNIS IOL ZMB00 (REF ZMB00U0225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474535671), received between Dec 8, 2016 and Apr 13, 2021 — 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 18, 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.

• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO THE TEAR OF THE CAPSULAR BAG. A REPLACEMENT LENS OF A DIFFERENT MODEL AND DIOPTER (21.5 D) WAS IMPLANTED ON CINGULATE MOTOR AREA (CMA) SULCUS. IT WAS INDICATED THAT THE ISSUE WAS FIRST NOTICED AT THE SURGERY. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME AT THE TIME DISCHARGE WAS REPORTED TO BE VERY WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11661983 ↗
• InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT DUE TO THE PATIENT BEING DISSATISFIED. THE EXPLANTED LENS WAS DISCARDED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8778862 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED POST-IMPLANT OF A MODEL ZMB00 22.5 DIOPTER INTRAOCULAR LENS, THE PATIENT EXPERIENCED UNEXPECTED POST-OP REFRACTION DUE TO A DISCREPANCY IN LENS POWER. THE LENS WAS EXPLANTED ON (B)(6) 2019 AND SUCCESSFULLY REPLACED WITH ANOTHER ZMB00 OF A LOWER DIOPTER (21.0). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. NO PATIENT INJURY REPORTED. OUTCOME WAS NOTED TO BE NORMAL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8635075 ↗
• 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 8303698 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 22.5 DIOPTER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018, BUT WAS LATER EXPLANTED ON (B)(6) 2018. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND ONE SUTURE WAS USED TO SEAL THE WOUND. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7466766 ↗
• InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT EXPERIENCED A SIGNIFICANT AMOUNT OF GLARE AND DUE TO PSEUDOPHAKIA WITH ASTHENOPIA. REPORTEDLY, THESE OUTCOMES SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. IT IS UNKNOWN IF AN INCISION ENLARGEMENT WAS PERFORMED, BUT IT WAS CONFIRMED THAT A VITRECTOMY WAS NOT PERFORMED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND NO ISSUES HAVE BEEN REPORTED POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7322011 ↗
• InjuryOct 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE OF A MALE PATIENT ON (B)(6) 2017. EXPLANT WAS DUE TO UNEXPECTED POSTOP REFRACTION. IT WAS REPORTED THAT THE SYMPTOMS WERE AFFECTING THE PATIENT'S DAILY ACTIVITIES. THE LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER 21.0 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 6927631 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2013. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE REFRACTIVE ERROR, POOR VISION, HALOS, AND GLARE. THE LENS WAS REPLACED WITH A DIFFERENT MODEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 6878220 ↗
• InjuryDec 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS NOT ABLE TO SEE NEAR AND FAR SIGHTED AFTER IMPLANTATION OF A ZMB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) IN HIS RIGHT EYE. THE PATIENT NOTED THE DOCTOR STATED THAT HE DEVELOPED SECONDARY CATARACTS AFTER THE CATARACTS WERE REMOVED THE PATIENT STILL HAD ISSUES WITH HIS VISION. THE PATIENT STATES THAT HE IS ABLE TO DRIVE BUT HAS A DIFFICULTY SEEING. HE VISITED ANOTHER DOCTOR FOR A SECOND OPINION AND THE DOCTOR PRESCRIBED THE PATIENT EYEGLASSES. THE GLASSES HELPED A LITTLE BIT. THE ZMB00 IMPLANTED ON THE RIGHT EYE IS BEING CAPTURED IN THIS REPORT AND A SEPARATE MDR IS BEING FILED FOR THE ZKB00 IMPLANTED ON THE LEFT EYE.

  Patient problems: No Code Available

  MAUDE report 6157136 ↗