TECNIS IOL ZLB00 (REF ZLB00U0095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474560468), received between Jul 13, 2018 and Jan 12, 2023 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A PLANNED EXPLANT OF THE INTRAOCULAR LENS (IOL) FROM THE RIGHT EYE SCHEDULED FOR (B)(6) 2022, DUE TO THE PATIENT'S VISION BEING VERY POOR IN REGARD TO BOTH DISTANCE AND READING. REPORTEDLY THE PATIENT WAS UNABLE TO SEE STREET SIGNS IN THE DISTANCE, AS WELL AS IT BEING VERY DIFFICULT TO SEE COMPUTER SCREENS. THE SYMPTOMS STARTED ON (B)(6) 2022. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS EXPLANTED ON (B)(6) 2022. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, DIFFERENT DIOPTER OF +10.5). A SECOND INCISION WAS NEEDED. THERE WAS PATIENT INJURY OF MILD INTRAOPERATIVE IRIS PROLAPSE. THE IRIS WAS "REPOSITED" BY THE SURGEON. AT ONE DAY POST-OPERATIVE THE PATIENT REPORTS NO OCULAR DISCOMFORT IN THE RIGHT EYE. THE PATIENT STATES THAT VISION IS "OKAY" IN THE RIGHT EYE AND CAN MAKE THINGS OUT AND SEE A LITTLE BETTER, BUT VISION IS STILL BLURRY. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Prolapse

  MAUDE report 16153569 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BROKEN CAPSULE. REPORTEDLY LENS HAD PATIENT CONTACT. BACK UP LENS WAS USED FOR THE PATIENT. PATIENT WAS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 9200537 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 9.5 DIOPTER WAS EXPLANTED DUE TO THE PATIENT BEING DISSATISFIED WITH THEIR NEAR VISION AS SHE WANTED TO BE ABLE TO SEE UP CLOSE TO READ. THERE WAS NOTHING WRONG WITH THE LENS. AS A RESULT THE LENS WAS EXPLANTED AND REPLACED WITH A NON JOHNSON AND JOHNSON IOL. REPORTEDLY THE PATIENT IS DOING FINE POST-OPERATIVELY. NO MORE INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 8530457 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN INCORRECT LENS POWER; PATIENT WAS UNHAPPY. THE LENS WAS REPLACED WITH THE SAME MODEL LENS BUT LOWER DIOPTER. THE PATIENT REPORTED DOING FINE POST EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8468244 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +9.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT PATIENT WAS EXPERIENCING DYSPHOTOPSIA AS IF LOOKING THROUGH PLASTIC. REPORTEDLY LENS WITH MODEL ZCB00 +9.5 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. GLUE WAS USED DURING THE PROCEDURE AND THERE WAS NO PATIENT INJURY. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7685429 ↗