TECNIS IOL ZLB00 (REF ZLB00U0255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474560789), received between Nov 18, 2016 and Apr 14, 2022 — classified as 9 injuries.

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.

• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAST NOT SEEN WELL SINCE THE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES. THE PATIENT REPORTED BEING UNABLE TO SEE AT NIGHT BECAUSE THE HEADLIGHTS ENGULF ENTIRE CARS. THE PATIENT STILL DRIVES AT NIGHT, BUT HAS TO BE VERY CAREFUL. THE PATIENT CAN STILL CAN SEE DURING THE DAY, BUT NIGHT TIME IS THE WORSE AND CAN'T LOOK DIRECTLY AT OUTSIDE LIGHTS AT ALL. THE VISUAL ISSUES ARE IN BOTH EYES AND STARTED RIGHT AFTER THE SURGERY, BUT THE PATIENT COULD NOT PROVIDE EXACT DATE. THE PATIENT REPORTED NOT REALLY BEING ABLE TO DO THE THINGS THE PATIENT WANTS TO DO. THE PATIENT WOULD LIKE TO REMOVE THE IOLS FROM THE EYES, BUT WAS TOLD THAT IT IS NOT POSSIBLE BECAUSE IT WOULD DETACH THE RETINA. THE IOLS FOR BOTH EYES REMAIN IMPLANTED. THE PATIENT REPORTED HAVING AN ATROPHIC RETINAL HOLE, WHICH OCCURRED ON (B)(6) 2022 IN THE LEFT EYE. THE PATIENT DESCRIBED IT AS A "BROWN, HAIRY BLOB" FLOATING AROUND IN THE VISION. THE RETINAL SPECIALIST ASKED IF THE PATIENT HAD FALLEN, BUT THE PATIENT REPORTED THAT HAD NOT OCCURRED. THE PATIENT SAW THE RETINAL SPECIALIST ON (B)(6) 2022 WHERE THE DOCTOR LASERED "AROUND THE HOLE IN THE RETINA." THE PATIENT REPORTED HAVING NO

  Patient problems: Dry Eye(s); Visual Disturbances

  MAUDE report 14116459 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED DUE TO PATIENT COMPLAINT OF BLURRY VISION. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, PATIENT IS DOING WELL POST-EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9386732 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNSPECIFIED INJURY. A REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON LENS, MODEL ZXR00 25.5 DIOPTER. THERE IS NO INCISION ENLARGEMENT OR SUTURE USED. REPORTEDLY, PATIENT IS DOING FINE POST-SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8658463 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF +25.5 DIOPTER LENS MODEL, ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) INTO THE PATIENT'S LEFT EYE, THE PATIENT'S READING VISION WASN'T WHAT THE PATIENT SEEKING. AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH +25.0 DIOPTER NON-JOHNSON AND JOHNSON SURGICAL VISION MONOFOCAL LENS. THE PATIENT WAS REPORTED TO BE DOING WELL AFTER REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8462850 ↗
• InjuryNov 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF RESIDUAL ASTIGMATISM AND MYOPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 24.0. REPORTEDLY, THE PATIENT IS DOING WELL AND THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8059142 ↗
• InjuryNov 8, 2018Expulsion; Expulsion

  IT WAS REPORTED THAT A ZLB00 25.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)() 2018 BECAUSE THE PATIENT COMPLAINED OF SEVERE HALOS AND GLARE. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. THE REPLACEMENT LENS WAS A ZCB00 25.5 DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING EXCELLENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8049678 ↗
• InjuryMay 8, 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, +25.5 DIOPTER) WAS REPOSITIONED POST OPERATIVE BECAUSE OF PATIENT EXPERIENCING NEGATIVE DYSPHOTOPSIA (TEMPORAL SHADOW) POST OP IN THE LEFT EYE (OS) THAT WOULD NOT SUBSIDE. THE DOCTOR REPOSITIONED THE LENS WITH THE HAPTICS ORIENTED HORIZONTALLY TO MITIGATE THE EFFECTS OF TEMPORAL SHADOWING. THE LENS WAS NOT EXPLANTED. NO ENLARGEMENT OF THE INCISION OCCURRED. THE REPOSITIONING WAS PERFORMED WITHOUT INCIDENT. THE PATIENT WAS REPORTED TO HAVE NO COMPLAINTS POST REPOSITIONING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7497396 ↗
• InjuryFeb 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZLB00 WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE. THE PATIENT HAD BEEN INCREASINGLY INTOLERANT TO THE GLARE AFTER 14 MONTHS. THE LENS WAS REPLACED WITH A ZA9003 LENS. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY DURING THE EXPLANTATION. PATIENT'S SURGERY HAD NO COMPLICATIONS AND WAS PRISTINE. PATIENT WANTED TO HAVE THE OTHER LENS REMOVED BUT THE PHYSICIAN RECOMMENDED FOR THE PATIENT TO WAIT LONGER TO SEE IF HER TOTAL DYSCHROMATOPSIA COULD BE CURED WITH THE REMOVAL OF JUST ONE LENS.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6323216 ↗
• InjuryNov 18, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT LEFT EYE DUE TO THE POWER BEING OFF BY 1.75 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO PATIENT INJURY POST-OP. LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 23.0 DIOPTER. AFTER THE REPLACEMENT THE PHYSICIAN REPORTED AN IMPROVEMENT ON PATIENT'S EYES.

  Patient problems: No Code Available

  MAUDE report 6114891 ↗