TECNIS IOL ZLB00 (REF ZLB00U0245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474560765), received between Sep 23, 2016 and Nov 30, 2023 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Adverse 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 AS THE PATIENT COMPLAINED OF GLARE AND HALO. ANOTHER JOHNSON & JOHNSON MONOFOCAL IOL OF DIFFERENT MODEL (DIB00) WITH LOWER DIOPTER (24.0 D) WAS USED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18243261 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT''S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WRONG LENS WAS USED. THE REPLACEMENT LENS USED IS A NON J&J LENS. THE PATIENT WAS DOING FINE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10570955 ↗
• InjuryFeb 3, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZLB00 24.5 DIOPTER WAS EXPLANTED FROM A PATIENT'S LEFT EYE (OS) DUE TO MECHANICAL FAILURE. IT WAS INDICATED THAT THE INCISION WAS ENLARGED AND THE IOL WAS REMOVED IN ONE (1) PIECE. THERE WAS NO SUTURES USED AND NO VITRECTOMY WAS REQUIRED. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Dizziness; Halo; No Code Available

  MAUDE report 9662313 ↗
• InjuryNov 6, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A MECHANICAL FAILURE. THE INCISION WAS ENLARGED, HOWEVER, NO ADDITIONAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 9283420 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZLB00 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IT WAS REPORTED THE PATIENT IS EXPERIENCING SEVERE LIGHT SENSITIVITY, STARBURSTS AROUND LIGHTS, AND IS ALSO HAVING GHOSTING EFFECTS. PRE-OPERATIVE VISUAL ACUITY WAS REPORTED AS 20/25, POST-OPERATIVE VISUAL ACUITY WAS 20/50, AND LENS EXPLANT IS SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8787288 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT TOLERATE THE IMPLANTED ZLB00 + 24.5 DIOPTER INTRAOCULAR LENS (IOL) IN HIS LEFT EYE (OS). FOR THAT REASON, THE LENS WAS EXPLANTED AND REPLACED WITH A ZLB00 +26.0 DIOPTER. THE INCISION WAS ENLARGED TO REMOVE THE LENS BUT THE PATIENT WAS DOING FINE WHEN DISCHARGED. THE ACCOUNT ALSO COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED AT THE SURGERY CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8390285 ↗
• InjuryMay 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 24.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS EXPERIENCING HALOS/GLARE AND WANTED THE LENS EXPLANTED. AT EXPLANT AN INCISION ENLARGEMENT WAS REQUIRED AND SUTURES WERE USED. THE REPLACEMENT LENS WAS A PCB00 26.5 DIOPTER LENS. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7528306 ↗
• InjuryApr 12, 2018Bent; Bent

  IT WAS REPORTED THAT THE PATIENT¿S VISION WAS FUZZY. THE CUSTOMER LOVED THE LENSES; HOWEVER, HIS VISION WAS NOT AS GOOD IN THE RIGHT EYE AS IT IS IN THE LEFT EYE. IT WAS MENTIONED THAT THE RIGHT EYE WATERS MORE AND THAT THE LEFT EYE IS CLEAR WHEN READING BUT THE RIGHT EYE IS FUZZY WHEN READING. THE PATIENT BELIEVES THAT THE TECHNICIAN MIGHT HAVE BENT THE LENS BEFORE INSERTING IT IN TO THE EYE. THE PATIENT REMEMBERS THE DOCTOR TALKING TO THE TECHNICIAN DURING PREPARATION STATING ¿YOU BENT THE LENS THE WRONG WAY¿ TO THE TECHNICIAN. THE PATIENT ALSO STATED HE HAD 20/20 VISION BEFORE BUT DUE TO THE CATARACT, HE NEEDED THE LENS IMPLANTED. HE ALSO HAD ASTIGMATISM IN HIS RIGHT EYE. THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: Excessive Tear Production; No Code Available; Visual Disturbances

  MAUDE report 7424208 ↗
• InjuryMar 21, 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 ZLB00, +24.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT''S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF THE PATIENT COMPLAINING OF SEVERE GLARE. REPORTEDLY, THE INCISION WAS ENLARGED DURING THE EXPLANT AND A NON-AMO INTRAOCULAR LENS WAS USED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7357197 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BILATERAL LENS IMPLANTS. THE LENS IN THE RIGHT EYE, A MODEL ZLB00 (+24.5 DIOPTER) WAS IMPLANTED IN THE RIGHT EYE AND THE VISION WAS 20/40. ALSO ASTIGMATISM HAD INCREASED POST-OP; THEREFORE HE PLANNED TO EXCHANGE THE ZLB00 IN THE RIGHT EYE WITH A ZXT150 +25.0 DIOPTER. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED AND REPLACED ON (B)(6) 2017. NO OTHER SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7054534 ↗
• InjuryMar 7, 2017Adverse 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 THE LENS SUBLUXATING DUE TO ZONULAR DEHISCENCE. A CAPSULAR TENSION RING WAS PLACED. THE DOCTOR TRIED TO PLACE THE RING TO SUTURE IN THE LENS; HOWEVER, IT BECAME CLEAR THAT THERE WAS ESSENTIALLY NO ZONULAR SUPPORT PRESENT, SO THE LENS WAS EXPLANTED AND A MODEL ZMA LENS WAS IMPLANTED. THE EVENT WAS RELATED TO PATIENT ANATOMY. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. THE LENS WILL NOT BE RETURNED.

  Patient problems: Inflammation; No Code Available; Zonular Dehiscence

  MAUDE report 6383039 ↗
• MalfunctionNov 22, 2016Torn Material; Torn Material

  IT WAS REPORTED THAT THE TIP OF INSERTER (CARTRIDGE) WAS BENT AND WHEN THE INTRAOCULAR LENS (IOL) TRIED TO ADVANCE, THE LENS AND THE LENS HAPTIC TORE. NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS FOR THE LENS. A SEPARATE MDR WILL BE FILED FOR THE CARTRIDGE.

  Patient problems: No Patient Involvement

  MAUDE report 6119645 ↗
• InjurySep 23, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS ORIGINALLY IMPLANTED IN (B)(6) 2016, AND THE PATIENT'S CORRECTED VISION WAS 20/30 AT THE FIRST 2 POST OP VISITS. THE FOLLOWING VISIT, HER VISUAL ACUITY WAS REDUCED TO 20/40 AND MOST RECENTLY SHE WAS 20/80. THE DOCTOR BELIEVES THE LENS SHIFTED, BUT IS UNSURE OF THE REASON FOR THE LENS MOVEMENT. A LENS EXPLANT WAS SCHEDULED FOR (B)(6) 2016; HOWEVER, THIS HAS NOT BEEN CONFIRMED TO HAVE OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 5975503 ↗