TECNIS IOL ZLB00 (REF ZLB00U0175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474560628), received between Mar 27, 2017 and Mar 15, 2022 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  A DFW150 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). HE COMPLAINS OF POOR VISUAL QUALITY AND WAXY VISION. PATIENT CANNOT TOLERATE THE LENS, AND IT NEEDS TO BE REMOVED; IOL EXPLANT SCHEDULED FOR (B)(6) 2022. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS EXPLANTED ON (B)(6) 2022 AND REPLACED WITH A DIB00 IOL. THERE WERE NO COMPLICATIONS AND NO SURGICAL INTERVENTIONS WERE REQUIRED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 13767748 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO POOR VISION AT DISTANCE AND NEAR/POOR READING AND BLURRY AT DISTANCE. PATIENT DID NOT LIKE THE QUALITY OF VISION AND COULD NOT PERFORM DUTIES AT WORK. THE EXCHANGE OF LENS WAS PERFORMED BY ANOTHER SURGEON. THE PATIENT VISUAL ACUITY (VA) PRE-OPERATIVE (OP) WAS 20/60 AND POST-OP IS AT 20/30. ANOTHER JOHNSON & JOHNSON LENS (DIU MODEL AND UNKNOWN DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT OUTCOME WAS NOT PROVIDED. THE CUSTOMER INDICATED THAT THE LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12375709 ↗
• InjuryMay 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO DISPLACED LENS. THE IOL WAS REMOVED BY A RETINA SURGEON. IT WAS STATED THAT THE SUSPECT PRODUCT WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846704 ↗
• InjuryMay 18, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE (OS) DUE TO MECHANICAL FAILURE. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED WHOLE. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846170 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE PATIENT IS EXPERIENCING HALOS AND GLARE IN THEIR RIGHT EYE POST-IMPLANT OF AN INTRAOCULAR LENS (IOL). THE VISUAL ISSUES ARE DEBILITATING AND AFFECTING THEIR NORMAL DAILY ACTIVITIES. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JNJ LENS. REPORTEDLY, THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11810939 ↗
• InjuryAug 21, 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 EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT AND THE OUTCOME DID NOT SIGNIFICANTLY AFFECT THE PATIENT ABILITY TO PERFORM DAILY ACTIVITIES. THE PATIENT HAS RECOVERED. NO RESPONSE HAS BEEN PROVIDED TO REQUESTS FOR ADDITIONAL DETAILS. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8914490 ↗
• InjuryAug 5, 2019Biofilm coating in Device; Defective Device; Biofilm coating in Device; Defective Device

  THE PATIENT CALLED TO REPORT HER EXPERIENCE WITH THE INTRAOCULAR LENS (IOL) IMPLANTED IN HER LEFT EYE (B)(6) 2016. PATIENT CALLED COMPLAINING ABOUT THE VISION IN HER LEFT EYE. SHE REPORTS EYE IS ALWAYS BLURRY. SHE SPOKE TO HER DOCTOR ABOUT IT AND HE PERFORMED A YAG (B)(6) 2016; HOWEVER, IT DID NOT FIX THE PROBLEM. REPORTEDLY, FOLLOWING THE PROCEDURE SHE WAS IN PAIN AND HER EYE WAS RED AND IRRITATED. THE DOCTOR INFORMED HER NOTHING WAS WRONG. SHE HAS SINCE MOVED AND IS SEEING A DIFFERENT DOCTOR, WHO STATED SHE HAD A FILM OVER THE LENS, REFERRED TO IT AS A LENS DEFECT, AND INFORMED HER SHE COULD HAVE AN EXCHANGE. THE PATIENT WANTED US TO KNOW ABOUT THE ISSUE, AND ALSO, WANTED TO KNOW WHAT JNJ COULD DO FOR HER. SHE STATES JOHNSON & JOHNSON WOULD HAVE A RESPONSIBILITY TO HER SINCE SHE HAD A DEFECTIVE LENS IMPLANTED. SHE STATED THE NEW DOCTOR EXAMINED HER EYE AND THEN CALLED OTHER PEOPLE INTO THE ROOM TO SEE HER LENS, BECAUSE IT WAS SUCH A RARE OCCURRENCE. THE DOCTOR'S OFFICE INFORMED HER THAT THERE IS AN "OPAQUE" FILM ON THE LENS. IN FOLLOW UP WITH THE NEW DOCTOR'S OFFICE, IT WAS LEARNED THAT.

  Patient problems: Blurred Vision; Burning Sensation; Dry Eye(s); Inflammation; Keratitis; Pain

  MAUDE report 8860039 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF A MECHANICAL FAILURE. IT WAS ALSO REPORTED THERE WAS NO SERIOUS PATIENT INJURY, NO VITRECTOMY, NO SUTURE(S), AND THE INCISION WAS ENLARGED. THROUGH FOLLOW-UP, THE MECHANICAL FAILURE WAS DEFINED AS VISUAL COMPLAINTS OF A CONSTANT CLOUDY, BLURRED VISION LIMITING NORMAL ACTIVITIES, ESPECIALLY FEELING UNSAFE TO DRIVE A CAR DUE TO THE BLURRED VISION. SPECTACLE CORRECTION DID NOT CLEAR THE CLOUDY, BLURRED VISION. HALOS AND GLARE WERE OF AN INTENSITY ALSO LIMITING NORMAL DAY TO DAY ACTIVITIES ESPECIALLY DRIVING DURING THE DAY OR AT NIGHT. THE LENS WAS REPLACED WITH AN AAB00 20.5 DIOPTER IOL, THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND PATIENT REPORTS A DRAMATIC IMPROVEMENT IN THEIR QUALITY OF VISION AND GOOD POSTOPERATIVE APPEARANCE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8724095 ↗
• InjuryFeb 12, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZLB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE LENS DID NOT REMAIN STABLE. THE REPLACEMENT LENS WAS A ZMA00 16.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7264174 ↗
• InjuryJan 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +17.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF VISUAL DISTURBANCE. MODEL ZMA00 INTRAOCULAR LENS WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. ADDITIONAL INFORMATION REPORTS THAT LENS DECENTERED POST IMPLANTATION AND VITRECTOMY WAS PERFORMED DURING THE EXPLANT. PATIENT HAS A BLEEDING DISORDER AND PATIENT WAS DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Vitrectomy

  MAUDE report 7192506 ↗
• InjuryOct 31, 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 DUE TO A POOR VISUAL OUTCOME IN THE PATIENT'S LEFT EYE. IT WAS REPORTED THAT THERE WAS AN IMPROPER CALCULATION AND THE TARGET WAS MISSED. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6989538 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO AN UNEXPECTED POST-OP REFRACTION RESULT. THIS PATIENT WAS A HIGH HYPEROPE AND HAS DRY EYE SO A LASIK COULD NOT BE PERFORMED. THE LENS WAS REPLACED WITH THE SAME MODEL IOL WITH A HIGHER DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. THERE WAS NO POSTOP ISSUES. AS STATED BY THE DOCTOR, THIS IS NOT A PRODUCT ISSUE JUST A REFRACTIVE SURPRISE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dry Eye(s); No Code Available

  MAUDE report 6682140 ↗
• MalfunctionMay 2, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SCRATCH ON THE INTRAOCULAR LENS (IOL) UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT. THE IOL WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6536048 ↗
• MalfunctionMay 2, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) UPON OPENING THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6536043 ↗
• InjuryMar 27, 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 FROM A FEMALE PATIENT''S RIGHT EYE, DUE TO DYPHOTOPSIA, HALOS AND GLARE. THE LENS WAS REPLACED WITH A MONOFOCAL LENS, A MODEL ZCB00 AND THE PATIENT WAS REPORTED FINE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO PATIENT POST-OP INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6437819 ↗