TECNIS IOL ZLB00 (REF ZLB00U0190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474560659), received between Jan 16, 2017 and Feb 24, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE AND REMOVED DUE TO REFRACTIVE ERROR. THE LENS WAS REMOVED AND REPLACED WITH THE ZLU150 LENS WITH 19.5 DIOPTER.IN THE SAME PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21447978 ↗
• InjuryJul 21, 2022Adverse 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 DISSATISFIED PATIENT AND RESIDUAL REFRACTIVE ERROR THAT IS UNACCEPTABLE. IT WAS STATED THAT DOCTOR USED LENSTAR BIOMETER AND THE QUANTAL ASCAN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15071457 ↗
• InjuryDec 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL FAILURE. A NEW INCISION WAS CREATED TO REMOVE THE IOL. THERE WAS NO VITRECTOMY, NO SUTURE , AND NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12993007 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT SHE CANNOT SEE AT NIGHT OR DRIVE AT NIGHT; HAS DOUBLE VISION, AND MUST SQUINT HER EYES TO SEE. SHE INDICATED SHE SPOKE WITH HER DOCTOR AND THE DOCTOR TOLD HER, HE DID NOT KNOW WHY SHE WAS NOT ABLE TO SEE. SHE ALSO INDICATED SHE WENT TO A RETINA SPECIALIST AND WAS TOLD SHE HAD NOTHING WRONG WITH HER RETINAS. SHE MENTIONED SHE HAD YAG SURGERY 1 MONTH AGO FOR POSSIBLE SECONDARY CATARACT AND IT DID NOT HELP HER VISION. SHE WAS PRESCRIBED SEVERAL EYE DROPS AND IT IS NOT HELPING HER VISION. SHE ALSO SAID SHE IS EXPERIENCING DRY EYE AND STARTED AFTER THE CATARACT SURGERY. SHE IS VERY UPSET THAT SHE HAS SEVERE GLARE. HER VISION IS WORST THAN BEFORE CATARACT SURGERY. SHE CANNOT SEE EVEN WITH GLASSES. THIS IS REPORT 2 OF 2 CAPTURING THE RIGHT EYE. THE LEFT EYE HAS BEEN CAPTURED IN ANOTHER REPORT.

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

  MAUDE report 12178605 ↗
• InjuryJul 7, 2021Adverse 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 RIGHT EYE DUE TO REFRACTIVE ERROR. INCISION WAS ENLARGED TO EXPLANT LENS FROM PATIENT'S EYE BUT NO VITRECTOMY WAS DONE. THIS EVENT WAS OBSERVED DURING POST OPERATIVE EXAMINATION. THERE WAS ALSO NO DELAY IN TREATMENT. IT WAS STATED THAT SUSPECT PRODUCT IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12129709 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO UNEXPECTED POST-OP REFRACTION. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10365874 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZLB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZLB00 19.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO GOAL OF PLANO WAS NOT MET, RESULT WAS +1.00 WITH COMPLAINT OF GLARE AND HALOS, THE PATIENT WAS NOT ABLE TO TOLERATE, AND OUTCOME SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THE ZLB00 LENS WAS REPLACED WITH A MODEL ZA9003 20.5 DIOPTER LENS. IT WAS REPORTED THE PATIENT HAS RECOVERED AND NO FURTHER INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 9690720 ↗
• InjurySep 6, 2019Adverse 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 +19.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING INTOLERANCE TO TMF (TECNIS MONOFOCAL) TECHNOLOGY. REPORTEDLY INCISION ENLARGEMENT WAS PERFORMED DURING THE EXPLANT PROCEDURE. LENS WITH MODEL PCB00 AND SAME DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8972148 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 FOR UNKNOWN REASONS. THE REPLACEMENT LENS WAS A ZXR00 20.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8303711 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING HALOS AND WAS NOT ABLE TO HANDLE HALOS AFTER THE IMPLANTATION OF A MODEL ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS). THE ZLB00 LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT IS REPORTED TO BE DOING GOOD AS HE IS MORE COMFORTABLE NOW WITHOUT THE HALOS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8272979 ↗
• InjuryJan 10, 2019Adverse 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 19.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN A SECONDARY PROCEDURE. LENS WITH MODEL ZLB00 +20.0 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8238350 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO UNEXPECTED POSTOP REFRACTION AND INTOLERANCE. THERE WAS NO SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7987823 ↗
• InjuryJan 15, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +19.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF BLURRY VISION. ADDITIONAL INFORMATION REPORTS THAT AN INCORRECT LENS POWER WAS USED FOR THE PATIENT. MODEL ZLB00 +20.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED AS A REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7192419 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS ALSO REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S VISUAL ACUITY WAS 20/70. THE PATIENT IS UNHAPPY WITH THEIR VISION GREATER THAN 3 MONTHS FROM THEIR SURGERY DATE. THE DOCTOR DOES NOT PLAN TO EXPLANT THE LENS AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 7177641 ↗
• MalfunctionDec 15, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZLB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED SCRATCHED ON INSERTION INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THERE WAS PATIENT CONTACT, BUT THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. THERE WAS NO PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7123595 ↗
• InjuryAug 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT BEING UNHAPPY WITH THEIR VISION. PATIENT IS FROM ANOTHER PRACTICE AND HAD A NON-AMO DEVICE IN THE FIRST EYE. THE EXPLANTED LENS WAS REPLACED WITH A NON-AMO IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6766234 ↗
• InjuryMar 24, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE ON (B)(6) 2017. THE REASON FOR THE EXPLANT WAS REPORTED AS A HYPEROPIC MISS. THERE WAS NO FAULT OF THE LENS. THE LENS WAS REPLACED THE SAME MODEL LENS, A ZLB00 ¿ 19.5 DIOPTER, A .5 DIOPTER SMALLER LENS. THE PATIENT SEEMS TO BE FINE POST-OP AND THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6434296 ↗
• InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 19.0 DIOPTER WAS EXPLANTED DUE THE PATIENT'S INTOLERANCE OF GLARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6254782 ↗