TECNIS IOL ZLB00 (REF ZLB00U0180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474560635), received between Nov 3, 2016 and Nov 17, 2021 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Adverse 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 REFRACTIVE SURPRISE DUE TO HALOS AND GLARES. ANOTHER JOHNSON & JOHNSON ZCB00 LENS (DIFFERENT MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. PATIENT IS DOING GOOD POST-OPERATIVELY. SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12829320 ↗
• InjuryJul 22, 2020Adverse 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. IT WAS LEARNED THAT THIS WAS DUE TO MISSED REFRACTION. IT WAS REPLACED WITH A SAME MODEL BUT DIFFERENT DIOPTER POWER (16.0) LENS. THERE WAS NO PATIENT POST-OP INJURY AND THE SUSPECT IOL IS NOT BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10309510 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT WAS UNABLE TO TOLERATE IT. BOTH DISTANCE AND NEAR VISION AT ONE MONTH WAS 20/70. THE PATIENT IS MONOCULAR, SO THIS WASN¿T SOMETHING SHE WAS ABLE TO TRY TO WAIT OUT. THE IOL WAS EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON MONOFOCAL LENS. ADDITIONAL INFORMATION STATES VISION PROGRESSIVELY WORSENED OVER ONE MONTH TO 20/70 BEST CORRECTED VISUAL ACUITY (BCVA) AT NEAR AND DISTANCE. ONE-MONTH POST EXPLANT/EXCHANGE THE PATIENT IS HAPPY WITH 20/20 UNCORRECTED AT DISTANCE AND 20/20 AT NEAR WITH CORRECTION. IT WAS ALSO NOTED, IN ORDER TO EXPLANT THE MULTIFOCAL LENS, THE PATIENT RETURNED TO THE OPERATING ROOM (OR) WHERE THE MAIN WOUND WAS REOPENED AND ENLARGED, THE FORMER LENS WAS CUT OUT USING THE PAC-MAN TECHNIQUE, AND THE NEW MONOFOCAL LENS WAS IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9861022 ↗
• InjuryAug 13, 2019Adverse 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 IN THE PATIENT'S EYE ON (B)(6) 2019. THE PATIENT COMPLAINED OF LACK OF NEAR VISION AND VISION JUST NOT CLEAR. ENDED UP +.5/-.25 NEAR AND 20/30 DISTANCE. IT WAS LATER EXPLANTED ON (B)(6) 2019 AND REPLACED WITH A ZXR00 IOL. THE SURGEON FEELS THAT HE CAN KEEP CLARITY AND AIMING MORE MINUS IN HIS CALCULATIONS THAT WILL HELP THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8887162 ↗
• InjuryJun 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS REMOVED AND EXCHANGED FROM THE LEFT EYE. THE IOL HAD DECENTERED, AND WAS EXCHANGED FOR A SULCUS ZMA00 IOL. THERE WAS NO INTERVENTION REQUIRED AND THE PATIENT WAS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8681031 ↗
• InjuryApr 4, 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 LEFT EYE DUE TO DYSPHOTOPSIA (HALOS/GLARE). THE LENS WAS REPLACED WITH A MODEL ZCB00, 18.5 DIOPTER LENS. PATIENT WAS DOING WELL POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8481338 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO REFRACTIVE ERROR. THE LENS WAS REPLACED WITH A MODEL ZA9003 MONOFOCAL LENS. AT EXPLANT SUTURES WERE REQUIRED AND THE PATIENT OUTCOME IS NOTED AS THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446986 ↗
• InjuryJan 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. ONE DAY POST-OP THE LENS WAS NOTICED DECENTERED. REPORTEDLY, THE PATIENT WAS FINE, BUT NOTICED BLURRINESS AND DOUBLE VISION. AS A RESULT, THE LENS WAS PLANNED TO BE EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A DIFFERENT LENS (MODEL AND DIOPTER UNKNOWN). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8211695 ↗
• InjuryDec 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZLB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE LENS DISLOCATING AT POST-OPERATIVE DAY 1. THE REPLACEMENT LENS WAS A ZMA00 18.0 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8182127 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF AN UNEXPECTED POST-OPERATIVE REFRACTION. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7815671 ↗
• InjuryJul 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZLB00 18.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE LENS DISLOCATED FROM ITS ORIGINAL POSITION POST-OPERATIVELY. THE REPLACEMENT LENS WAS A ZXR00 20.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7693611 ↗
• InjuryMay 23, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A MODEL ZLB00U0180 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO INCORRECT POWER LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7539658 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH A Z9002 17.5 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7291291 ↗
• InjuryAug 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A TECNIS 1 MULTIFOCAL INTRAOCULAR LENS, MODEL ZLB00 18.0 DIOPTER, WAS IMPLANTED INTO A PATIENT''S RIGHT EYE ON (B)(6) 2016. PRIOR TO SURGERY, THE PATIENT NOTES A GENERAL DECREASED VISION FROM BEFORE SURGERY. HER VISION TO WATCH TV IS NOT AS GOOD AS IT USED TO BE AND SHE HAS TROUBLE READING AS WELL. AFTER SURGERY, THE PATIENT IS VERY DISAPPOINTED AND COMPLAINS OF SEEING HORIZONTAL AND VERTICAL LINES. THE DOCTOR PLANS TO TRY A CONTACT LENS TRIAL TO SEE IF DISTANCE VISUAL ACUITY COULD BE IMPROVED BY CORRECTING ASTIGMATISM, TRIALING DISTANCE ONLY GLASSES, AND COULD CONSIDER REFRACTIVE SURGERY IF NEEDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 6819663 ↗
• InjuryMar 1, 2017Adverse 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 AS THE PATIENT DID NOT HAVE QUALITY VISION WITH THIS LENS. IMPROPER FIT FOR THE PATIENT WAS ALSO REPORTED. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, AND NO SUTURES WERE REQUIRED. THE LENS WAS REPLACED WITH ANOTHER LENS, A DIFFERENT MODEL, A ZCB00 +18.0 DIOPTER MONOFOCAL LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6367328 ↗
• InjuryNov 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO HALOS. THE ZLB00 WAS EXPLANTED AND REPLACED WITH A ZCT225 18.0 DIOPTER IOL. LENS EXCHANGE WAS SUCCESSFUL WITH NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. NO POST OP PATIENT INJURY WAS REPORTED.

  Patient problems: Halo; No Code Available

  MAUDE report 6074887 ↗