TECNIS IOL ZLB00 (REF ZLB00U0250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474560772), received between Nov 9, 2016 and Apr 14, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HASN'T SEEN WELL SINCE THE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES. THE PATIENT REPORTED BEING UNABLE TO SEE AT NIGHT BECAUSE THE HEADLIGHTS ENGULF ENTIRE CARS. THE PATIENT STILL DRIVES AT NIGHT, BUT HAS TO BE VERY CAREFUL. THE PATIENT CAN STILL CAN SEE DURING THE DAY, BUT NIGHT TIME IS THE WORSE AND CAN'T LOOK DIRECTLY AT OUTSIDE LIGHTS AT ALL. THE VISUAL ISSUES ARE IN BOTH EYES AND STARTED RIGHT AFTER THE SURGERY, BUT THE PATIENT COULD NOT PROVIDE EXACT DATE. THE PATIENT REPORTED NOT REALLY BEING ABLE TO DO THE THINGS THE PATIENT WANTS TO DO. THE PATIENT WOULD LIKE TO REMOVE THE IOLS FROM THE EYES, BUT WAS TOLD THAT IT IS NOT POSSIBLE BECAUSE IT WOULD DETACH THE RETINA. THE IOLS FOR BOTH EYES REMAIN IMPLANTED. THE PATIENT REPORTED HAVING NO PRE-EXISTING CONDITIONS. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION HAS BEEN REQUIRED. THERE WAS NO COMPLICATION OR ANY PATIENT INJURY DURING THE IMPLANT SURGERY. THE PATIENT REPORTED THAT THE EYES ARE DRY A LOT AND THE PATIENT USES OVER THE COUNTER LUBRICATING DROPS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE EVENT. A SEPARATE REPORT WAS FILED TO CAPTURE T

  Patient problems: Dry Eye(s); Visual Disturbances

  MAUDE report 14116458 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SPIDER WEB VISION AND BLURRED VISION WITH AN INTRAOCULAR LENS (IOL) IN BOTH EYES. THE PATIENT'S DISTANT VISION IS GOOD, HOWEVER, CLOSE-UP VISION IS HORRIBLE. THE PATIENT IS USING A MAGNIFYING GLASS JUST TO READ. THROUGH FOLLOW-UP, IT WAS LEARNED VISON IS GOOD FAR AWAY, VISION MID-RANGE IS MUCH BETTER, HOWEVER, CLOSE-UP IS DISAPPOINTING BECAUSE SHE HAS TO WEAR GLASSES TO DO PUZZLES. PATIENT IS NOT HAPPY SHE HAS TO WEAR GLASSES AS SHE WAS TOLD SHE WILL NOT NEED GLASSES. THE PATIENT CLARIFIED THAT HER SPIDER WEB VISION WAS MORE OF A FIXED LOCATION ISSUE. AFTER SHE RECEIVED THE LASER TREATMENT, IT SOMEWHAT IMPROVED A LITTLE. THE PATIENT HAS HAD LASER TREATMENTS DONE ON BOTH OF HER EYES WHICH ALSO FIXED THE CLOUDINESS, BUT DID NOT FIX HER VISION ISSUES. VISION IS STILL FUZZY. NO DATES WERE PROVIDED FOR THE LASER TREATMENT NOR THE TYPE OF LASER TREATMENT WAS PROVIDED. THE PATIENT CONFIRMED HER VISUAL ISSUE IS NOT DEBILITATING. THE PATIENT IS ABLE TO DO DAILY ACTIVITIES, HOWEVER, VISUAL ISSUES ARE BOTHERSOME. AT THIS TIME, THE LENSES REMAIN IMPLANTED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11988239 ↗
• InjuryApr 22, 2020Adverse 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 DUE TO THE PATIENT NOT SEEING PROPERLY. REPLACEMENT IOL WAS A NON-JOHNSON AND JOHNSON PRODUCT. THE IMPLANT AND EXPLANT DATES WERE PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9988197 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO DYSPHOTOPSIA. A REPLACEMENT LENS IS A ZCB00 25.0 DIOPTER. REPORTEDLY, PATIENT IS DOING FINE POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8909684 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE PATIENT INSISTED THAT A POOR QUALITY LENS, A MODEL ZLB00 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO HER OPERATIVE EYE. SHE ALSO COMPLAINED OF HAVING BLURRY VISION, GLARE AT NIGHT, AND POOR DISTANCE/NEAR VISION. HER VISUAL ACUITY BEFORE SURGERY WAS 20/40, AND POST-OPERATIVE IS 20/25. A LENS EXCHANGE HAS BEEN SCHEDULED FOR (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8368862 ↗
• InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE A ZLB00 25.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT HAVING HYPEROPIA. ADDITIONALLY, PATIENT WAS HAVING TROUBLE ACCOMMODATING TO THE LENS. THE LENS WAS EXCHANGED AND THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6593278 ↗
• InjuryNov 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 25.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT DISSATISFACTION AND WAXY VISION. THERE WAS NO INCISION ENLARGEMENT AND PATIENT IS DOING OKAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6091539 ↗