TECNIS IOL ZLB00 (REF ZLB00U0140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474560550), received between Sep 13, 2016 and Jan 23, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZLB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO PATIENT COMPLAINTS OF DIFFICULTY SEEING STREET SIGNS AND NIGHT DRIVING DUE TO GLARE AND HALOS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION 14.0 DIOPTER IOL. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTION. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18565315 ↗
• InjuryFeb 17, 2022Adverse 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 LEFT EYE DUE TO THE PATIENT EXPERIENCING NIGHT GLARE AND NOT GETTING READING VISION. ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL DIB00, DIFFERENT DIOPTER OF +14.5) WAS IMPLANTED AS REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT'S VISUAL ACUITY POST-OPERATIVELY IS 20/25. THE IOL WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13553329 ↗
• InjuryFeb 13, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED A ZLB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE ZLB00 LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINT OF MECHANICAL FAILURE. THERE WAS NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY REPORTED, HOWEVER THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED IN ONE PIECE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9704375 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZLB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2018. THE LENS WAS EXPLANTED (B)(6) 2018 DUE TO COMPLAINT OF UNEXPECTED POST-OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT WAS REQUIRED. IT WAS REPORTED PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 8109501 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 14.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT HAD DECREASED VISUAL ACUITY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 7868576 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017, BECAUSE THE PATIENT EXPERIENCED HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED AND THE PATIENT IS DOING OKAY. REPORTEDLY, THE VISUAL SYMPTOMS INTERFERED WITH REGULAR ACTIVITIES. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZCB00 LENS. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7147010 ↗
• InjuryMar 29, 2017Torn Material; Device Handling Problem; Torn Material; Device Handling Problem

  A REPORT WAS RECEIVED THAT A TECNIS 1 MULTIFOCAL (TMF) MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT¿S OPERATIVE EYE DURING THE SAME PROCEDURE DUE TO IOL WAS CRACKED/TORN. THE SURGERY CENTER INDICATED THE CRACKED/TORN IOL WAS A RESULT OF USE/HANDLING ERROR AND NO COMPLAINT ON THE IOL DEVICE. AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE ORIGINAL IOL. THE REMOVED IOL WAS DESTROYED AND DISCARDED BY THE SURGERY CENTER. THE REPLACEMENT LENS WAS ANOTHER ZLB00 IOL. IT IS NOTED THAT A NON-VALIDATED, NON-AMO CARTRIDGE WAS USED IN THE PROCEDURE WHICH MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE.

  Patient problems: No Code Available

  MAUDE report 6444919 ↗
• InjurySep 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A MALE PATIENT EXPERIENCED TERRIBLE HALOS (BRIGHT CIRCLES THAT APPEAR TO SURROUND A SOURCE OF LIGHT) AROUND CAR LIGHTS, LAMP POSTS, LIT SIGNS AT NIGHT WHICH MAKE DRIVING AT NIGHT UNSAFE AND IRRITATING. HE HAS BEEN EXPERIENCING THESE SYMPTOMS ALMOST IMMEDIATELY AFTER IMPLANTATION OF A ZLB00 MULTIFOCAL LENS. IN FOLLOW UP WITH THE SURGERY CENTER IT WAS ASKED IF THERE WAS ANYTHING IN THE PATIENT'S CHART ATTRIBUTING THE PATIENT'S VISUAL ISSUES TO THE LENS. THE RESPONSE WAS THAT NOTHING WAS FOUND ABOUT IT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Irritation; Visual Disturbances

  MAUDE report 5947812 ↗