TECNIS IOL ZLB00 (REF ZLB00U0225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05050474560727), received between Aug 22, 2016 and Jun 13, 2025 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH A 22.5 DIOPTER ZCB00 MODEL LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22207459 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO AN UNSPECIFIED REASON. THE REPLACEMENT LENS IS A DIFFERENT MODEL ZLU300, 22.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19056431 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT. ONE MONTH REFRACTION WAS -.50, .50 BEST CORRECTED WAS 20/60. TRIED CONTACT LENS UNSUCCESSFULLY AS WELL. OVERALL NOT HAPPY WITH VISUAL OUTCOME. PATIENT WILL BE HAVING ZLB00 REMOVED AND REPLACED WITH A LIGHT ADJUSTABLE LENS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 STATED THAT THE LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE ON (B)(6) 2023 AND THE REASON FOR EXPLANT WAS THAT THE PATIENT WAS NOT HAPPY WITH HER VISION. PATIENT DID NOT HAVE ANY OTHER ISSUES. THERE WAS NO PATIENT INJURY AND NO OTHER ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PRODUCT IS NOT BEING RETURNED. THE REPLACEMENT LENS WAS NON JNJ LENS. PATIENT WAS DOING GOOD POST SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 17826024 ↗
• InjuryApr 6, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED AND HAD TO BE EXPLANTED RECENTLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022773 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTS DIZZINESS AND NAUSEA, SHE HAS TWITCHING IN HER RIGHT EYE. SHE WAS TOLD SHE WOULD BE ABLE TO READ, BUT SHE HAS DIFFICULTY READING AND SHE SEES GIGANTIC HALOS AT NIGHT AROUND STREET LIGHTS. PATIENT IS HAPPY THAT SHE CAN SIT ON HER SOFA AND WATCH TV AND READ HER TV GUIDE WITHOUT GLASSES, BUT SHE CAN NOT WRITE OR READ WITHOUT HER OLD GLASSES. HER MAIN CONCERN IS HER FEELING DIZZY AND NAUSEOUS. THERE IS A GREAT IMPROVEMENT WITH HER VISION, BUT IT IS NOT WHAT SHE EXPECTED- SHE EXPECTED NOT TO NEED HER GLASSES, BUT SHE DOES. PATIENT ALSO ADDED THAT SHE SQUINTS IN THE SUNLIGHT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING AFTER OD IOL IMPLANT PATIENT ALSO EXPERIENCED VOMITING AND LIGHT SENSITIVITY. DIZZINESS LASTED FOR ABOUT TWO (02) WEEKS AND SHE HAS BEEN NAUSEOUS FOR ABOUT A MONTH NOW. OD IS STILL TWITCHING AND PATIENT REPORTED FLOATERS AND BLURRINESS. DISTANCE VISION IS GOOD, BUT SHE CAN ONLY READ USING PROGRESSIVE LENSES THAT SHE HAD PRIOR TO LENS IMPLANTATION OR BY USING A MAGNIFYING GLASS. ON (B)(6) 2022 IN THE MIDDLE OF THE NIGHT, THE PATIENT EXPERIEN

  Patient problems: Blurred Vision; Eye Pain; Halo; Inflammation; Insufficient Information; Nausea; Red Eye(s); Visual Disturbances; Vitreous Floaters

  MAUDE report 13406352 ↗
• MalfunctionDec 13, 2020Material Opacification; Material Opacification

  IT WAS REPORTED THAT APPROXIMATELY NINE DAYS POST-IMPLANTATION OF A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL), THE CENTER OF THE LENS APPEARED TO BE OPACIFIED. IT WAS NOTED THE PATIENT IS GETTING A SYMFONY LENS SO THE SURGEON WILL WAIT TO SEE HOW EVERYTHING IS WORKING AFTER THAT. NO MEDICAL INTERVENTION WAS REQUIRED, AND THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10998904 ↗
• InjuryOct 24, 2020Break; Break

  IT WAS REPORTED THAT A ZLB00 MODEL INTRAOCULAR LENS (IOL) HAD BENT HAPTIC WHICH WAS PARTIALLY INSERTED AND REMOVED FROM PATIENT''S LEFT EYE. INCISION WAS ENLARGED TO REMOVED THE LENS FROM PATIENT''S EYE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT LENS, SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DOING GREAT THE DAY AFTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10731635 ↗
• InjuryOct 6, 2020Adverse 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 RIGHT (OD) EYE DUE TO WRONG POWER. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. THE REPLACEMENT LENS IS A SAME MODEL, BUT A HIGHER DIOPTER (24.0). REPORTEDLY, THE PATIENT IS DOING GOOD POST-OPERATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10633193 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANT OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED ANISOMETROPIA AND VISION IMBALANCE AFFECTING THE PATIENT'S READING. VISUAL ACUITY (VA) PRE-OPERATIVE 20/40, PATIENT HAD GLARE AND HALOS AT NIGHT. POST-OPERATIVE VA 20/20. THE LENS WAS EXPLANTED AND A NEW LENS WAS IMPLANTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10348342 ↗
• InjuryFeb 26, 2020Adverse 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 OPERATIVE EYE ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO REFRACTIVE SURPRISE. THERE WAS NO SURGICAL INTERVENTION REQUIRED AND THE LENS WAS DISCARDED AND WILL NOT COMING BACK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9759633 ↗
• InjuryFeb 10, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED A MODEL ZLB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZLB00 LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO INITIAL COMPLAINT OF BLURRED VISION FROM THE PATIENT. THE SURGEON NOTICED LATHE MARKS ON THE LENS WITH SLIT LAMP, REFRACTION WAS +.50 -.25. AT A LATER FOLLOW-UP THE PATIENT COMPLAINED OF FOREIGN BODY SENSATION IN THE EYE, AND STROBE LIGHT EFFECT AT NIGHT, REFRACTION +.50. THE ZLB00 LENS WAS EXPLANTED AND REPLACED WITH A MODEL ZLB00 22.5 DIOPTER IOL. THERE WAS NO PATIENT CONSEQUENCE OR WOUND ENLARGEMENT, NO VITRECTOMY, AND THE PATIENT WAS STABLE WHEN LEAVING SURGERY CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Disturbances

  MAUDE report 9689564 ↗
• InjurySep 27, 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 DUE TO GLARE. THE VISUAL ACUITY PRE OP WAS 20/30. THE INCISION WAS ENLARGED. SUTURES WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9129374 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A MYOPIC SURPRISE. THE SURGEON EXPLANTED THE INTRAOCULAR LENS (IOL) AND REPLACED IT WITH ANOTHER MODEL WITH A LOWER DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9089064 ↗
• InjurySep 12, 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 DUE TO ANISOMETROPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. IT WAS NOTED THAT THE PATIENT WAS DOING WELL POST-OP. IN FOLLOW-UP IT WAS LEARNT THAT THE REPLACEMENT LENS WAS ANOTHER ZLB00 BUT HIGH DIOPTER POWER. THERE WAS NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9001007 ↗
• InjuryJan 15, 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 OPERATIVE EYE DUE TO ANISOMETROPIA. A MODEL ZCB00 LENS WAS THE REPLACEMENT LENS. THE PATIENT WAS REPORTED AS DOING WELL POST EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8247075 ↗
• InjuryDec 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.5 DIOPTER THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCB00 22.5. THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT WAS DOING WELL POST EXCHANGE.

  Patient problems: Halo; No Code Available

  MAUDE report 8205390 ↗
• InjuryNov 29, 2018Adverse 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 INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2018. TWO WEEKS AFTER SURGERY, THE REFRACTION WAS +1. THE PATIENT COMPLAINED OF HALOS AND SENSITIVITY TO LIGHT IN THE OPERATIVE EYE. THE PATIENT'S ABILITY TO PERFORM DAILY ACTIVITIES WAS AFFECTED TO MILD EXTENT; PATIENT HAD DIFFICULTY GOING OUTSIDE OR BEING AROUND BRIGHT LIGHTS. ONE MONTH POST-OP THE PATIENT CONTINUED TO HAVE A +1 DIOPTER REFRACTIVE ERROR, PERSISTENT SYMPTOMS OF HALOES/GLARE AND POOR VISION. VISUAL ACUITY PRE-OP: 20/40. VISUAL ACUITY POST-OP: 20/70, J4. A LENS EXCHANGE WAS PLANNED FOR (B)(6) 2018. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available; Visual Impairment

  MAUDE report 8114440 ↗
• InjurySep 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 22.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF AN UNEXPECTED POST-OPERATIVE REFRACTION. THERE WAS NO INCISION ENLARGEMENT MADE AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 24.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7897094 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS UNHAPPY WITH THEIR READING VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES. THE REPLACEMENT LENS WAS A ZCB00 22.0 DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7831796 ↗
• InjuryApr 5, 2018Adverse 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 UNEXPECTED POST-OPERATIVE REFRACTION. THE IOL WAS REPLACED WITH AN IOL OF ANOTHER DIOPTER AND MODEL (ZLB00, 23.5 DIOPTER). THERE WAS NO PATIENT POST-OPERATIVE INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7398526 ↗
• InjuryNov 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZLB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNSPECIFIED MECHANICAL COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 7069567 ↗
• InjuryNov 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) IS PLANNED TO BE EXPLANTED FROM THE PATIENT'S OPERATIVE EYE BECAUSE THE PATIENT EXPERIENCED HAZE AND REQUESTED AN EXPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7057341 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING VERY BLURRED VISION WITH HALOS, AFFECTING THE PATIENT'S DRIVING. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 21.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. ADDITIONALLY, THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6423372 ↗
• InjuryDec 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY, IT WAS REPORTED BY (B)(4). THAT A MALE PATIENT EXPERIENCED BLURRY VISION AND FLOATERS AFTER IMPLANTATION OF AN ABBOTT PRODUCT AND IS CONTINUING. DURING A FOLLOW UP, CUSTOMER PROVIDED SERIAL NUMBERS (B)(4) IMPLANTED IN PATIENT'S LEFT EYE AND RIGHT EYE RESPECTIVELY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE LENS IMPLANTED IN PATIENT'S RIGHT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S LEFT EYE.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 6207944 ↗
• InjuryDec 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.5 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO HALOS AND GLARE. THE PATIENT IS 6/6 ON BOTH EYES. THERE WERE NO ZERO REFRACTIVE ERROR, NO ASTIGMATISM, PERFECTLY PLACED, WELL CENTERED WITH HEALTHY CORNEAS, CLEAR CAPSULES, AND NORMAL RETINAS. HOWEVER AFTER 6 MONTHS, SHE COULD NOT TOLERATE THE UNWANTED SYMPTOMS AND EXPLANTING WAS THE BEST COURSE TO RELIEVE HER SYMPTOMS. THIS REPORT IS TO CAPTURE THE LENS EXPLANTED FROM THE PATIENT'S RIGHT EYE AND A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE PATIENT LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6201569 ↗