TECNIS IOL ZLB00 (REF ZLB00U0150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474560574), received between Oct 23, 2017 and Dec 15, 2022 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH THE INTRAOCULAR LENS (IOL) IMPLANTED INTO PATIENT'S RIGHT EYE AND WAS COMPLAINING OF HAZY VISION. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE LENS WAS EXPLANTED AND ANOTHER COMPETITOR LENS OF +12.0 DIOPTER WAS USED AS THE REPLACEMENT. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/80 AND VISUAL ACUITY POST IMPLANTATION WITH THE ORIGINAL LENS WAS 20/40. NO OTHER MEDICAL/ SURGICAL INTERVENTION PERFORMED. THE PATIENT WAS STILL RECOVERING FROM THE EXPLANT SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15988749 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZLB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO ANISOMETROPIA. THE REPLACEMENT LENS WAS THE SAME MODEL LENS BUT A HIGHER DIOPTER (16.0). THE PATIENT IS REPORTED AS DOING FINE POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8909099 ↗
• InjuryApr 10, 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 FROM THE PATIENT'S LEFT EYE (OS) DUE TO HALOS AND GLARE. REPORTEDLY, THE INCISION WAS ENLARGED TO REMOVE THE LENS BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE REQUIRED. A MONOFOCAL LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT'S PRE-OP VISUAL ACUITY WAS 20/100. POST OP VISUAL ACUITY WAS 20/400. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED AT THE SURGERY CENTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 8499219 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 15.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF MECHANICAL COMPLICATIONS AND THE PATIENT NON-ADAPTING TO THE LENS. THERE WAS AN INCISION ENLARGEMENT, BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. THE REPLACEMENT LENS WAS A ZA9003 13.0 DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7672048 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. AN ATTEMPT TO REPOSITION THE LENS FAILED BECAUSE THE DOCTOR COULD NOT ROTATE THE LENS. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH A ZMA00 14.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7336964 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH A ZXR00 15.5 DIOPTER INTRAOCULAR LENS (IOL). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6967894 ↗