TECNIS IOL ZLB00 (REF ZLB00U0165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474560604), received between Aug 29, 2016 and Sep 19, 2024 — classified as 7 injuries, 2 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL LENS (IOL) WAS EXPLANTED DUE TO CONTRACTION ISSUES. THE IOL WAS THE CORRECT MODEL AND POWER, BUT THE PATIENT HAD COMPLAINTS OF HALOS AND GHOST IMAGES, POSSIBLY INDICATING A PERIPHERAL CAPSULAR TEAR OR ZONULAR DEHISCENCE. THE PHYSICIAN OBSERVED THESE POSSIBILITIES. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH AN UNKNOWN IOL. THE PATIENT MENTIONED EXPERIENCING BLURRY VISION AND THE OUTCOME IS YET TO BE DETERMINED. NO OTHER INTERVENTIONS HAVE BEEN NEEDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Impairment; Zonular Dehiscence

  MAUDE report 20257317 ↗
• MalfunctionJul 1, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AS IT WAS SCRATCHED AT ITS CENTER. ANOTHER LENS OF SAME MODEL AND DIOPTER (SN(B)(4)) WAS USED AS THE REPLACEMENT. THE EVENT WAS OBSERVED AFTER INSERTION INTO THE EYE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105051 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT BEING UNHAPPY WITH VISION, DISTANCE VISUAL ACUITY (VA) IS NOT SHARP AND NEAR VA IS NOT CLEAR. PATIENT ALSO STATED VISION IS NOT CLEAR WITH BLURRY AND SOME IRRITATION. THERE WAS NO DELAY AND NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY AT EXPLANT. THE EXPLANTED LENS WAS REPLACED WITH MODEL ZMB00 15.5 DIOPTER IOL. THE EXPLANTED LENS WAS DISCARDED. VISUAL ACUITY PRE-OPERATIVE: 20/25. VISUAL ACUITY POST-OPERATIVE: 20/20-3 (POST-OP DAY ONE). NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11143953 ↗
• InjuryJul 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 +16.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017 AND LATER EXPLANTED ON (B)(6) 2018 BECAUSE AN INCORRECT LENS POWER WAS IMPLANTED. THE REPLACEMENT LENS WAS A ZCB00 +17.0 DIOPTER. REPORTEDLY, THE PATIENT IS DOING OKAY POST-OPERATIVELY AND THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7721923 ↗
• InjuryNov 14, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO WRONG DIOPTER CALCULATED AND IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6100893 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE OF A MALE PATIENT DUE RESIDUAL REFRACTIVE ERROR, A DIFFERENT DIOPTER SIZE WAS REQUIRED. THERE WAS NO INJURY TO THE PATIENT. THE LENS WAS REPLACED WITH THE SAME MODEL LENS BUT A HIGHER DIOPTER (17.5). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6088290 ↗
• InjuryOct 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO THE PATIENT EXPERIENCING A WAXY VISION. THERE WAS NO INCISION ENLARGEMENT AND VITRECTOMY REQUIRED. LENS WAS REPLACED WITH A NON-AMO DEVICE. THE EXPLANTED LENS WAS SCRAPPED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6052964 ↗
• MalfunctionSep 21, 2016Break; Component Falling; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT AFTER INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), A LINE THROUGH THE LENS APPEARING TO BE A SCRATCH WAS NOTICED. REPORTEDLY THE LENS WAS REMOVED FROM THE EYE AND IT BROKE INTO PIECES. IT FELL ON THE FLOOR AND GOT LOST. ANOTHER LENS WAS IMPLANTED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5966838 ↗
• InjuryAug 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN REMOVED AFTER THE DOCTOR DISCOVERED A COMPROMISE IN THE CAPSULAR BAG. A MODEL ZMA00 LENS WAS SUBSEQUENTLY IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 5912595 ↗