TECNIS IOL ZLB00 (REF ZLB00U0220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05050474560710), received between Sep 27, 2016 and Sep 17, 2024 — classified as 29 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivery System Failure” (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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS WAS EXPLANTED. THE LENS WAS EXPLANTED AND REPLACED WITH A ZLU225 22.0 LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 20242332 ↗
• InjuryMar 19, 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 PATIENT'S LEFT EYE DUE TO THE PATIENT EXPERIENCING HYPEROPIC OUTCOME. THE VISUAL ISSUES WERE FIRST OBSERVED DURING A POST-OP EXAM. SYMPTOMS LASTED ABOUT 2 MONTHS. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE IOL WAS REPLACED WITH ANOTHER JNJ LENS OF THE SAME MODEL ZLB00 BUT 22.5 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAY IN PROCEDURE. MEDICATION OUTSIDE THE STANDARD OF CARE WAS NOT PRESCRIBED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT IMPACTED BY THIS EVENT. PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18938335 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF MULTIFOCAL INTOLERANCE. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, DIOPTER SIZE IS UNKNOWN. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 17578254 ↗
• InjuryFeb 3, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO MECHANICAL FAILURE. INCISION ENLARGEMENT AND VITRECTOMY WERE REQUIRED. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9663128 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZLB00 INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENTS RIGHT EYE WAS EXPLANTED DUE TO PATIENTS COMPLAINT OF POOR INTERMEDIATE VISION WHICH THE PATIENT WAS UNABLE TO TOLERATE AND UNEXPECTED POST-OP REFRACTION. THE EXPLANTED LENS WAS REPLACED WITH AN IOL OF A DIFFERENT MODEL. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8952022 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT COMPLAINED THAT THE VISUAL QUALITY WAS NOT AS GOOD AS THEIR FELLOW EYE WHICH HAS A SYMFONY LENS IMPLANTED. THE LENS WAS EXCHANGED FOR A ZXT150 21.5 DIOPTER LENS IN A SECONDARY SURGERY. NO INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT IS OKAY AND IN GOOD HEALTH POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8689562 ↗
• InjuryMay 13, 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 PATIENT'S EYE DUE TO FUZZY, HAZY VISION WHICH COULD NOT BE IMPROVED WITH THE PRESCRIPTION SPECTACLES. THERE WAS NO MEDICAL INTERVENTION REQUIRED LIKE VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. PATIENT OUTCOME AFTER REPLACEMENT PROCEDURE STATES VISION IS IMPROVING WITH BETTER CLARITY THAN WITH THE EXPLANTED LENS. VISUAL ACUITY PRE-INITIAL IMPLANT: 20/50. VISUAL ACUITY POST-INITIAL IMPLANT: FUZZY 20/40. VISUAL ACUITY POST-REPLACEMENT/REPOSITIONING: SHARPER 20/40. NO OTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8605452 ↗
• InjuryApr 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.0 DIOPTER MULTIFOCAL LENS WAS EXPLANTED FROM THE PATIENT¿S EYE DUE TO THE PATIENT EXPERIENCING HYPEROPIA POST IMPLANT. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT AND NO OTHER COMPLICATIONS. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8490080 ↗
• InjuryMar 8, 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 A REFRACTIVE ERROR AND THE PATIENT BEING BOTHERED BY HALOS GENERATED BY THE MULTIFOCAL LENS. NO WOUND ENLARGEMENT AND NO VITRECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED DOING WELL POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8403464 ↗
• InjuryDec 5, 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 IN THE PATIENT'S LEFT EYE (B)(6) 2016 AND EXPLANTED ON (B)(6) 2018 DUE TO PATIENT COMPLAINING OF BLURRY VISION. A VITRECTOMY AND INCISION ENLARGEMENT WERE ALSO PERFORMED. THE PATIENT WAS REPORTED DOING OK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 8132301 ↗
• InjuryOct 24, 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 EXPLANTED ON (B)(6) 2018 DUE TO PATIENT COMPLAINT OF BLURRY VISION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. A COMPETITOR LENS WAS IMPLANTED AS A REPLACEMENT. ADDITIONAL INFORMATION PROVIDED THE IMPLANT DATE AS (B)(6) 2018 AND THE FIRST REPORT OF BLURRY VISION AT 1 WEEK POST-OP. THE PATIENT HAD CORNEAL EDEMA AT 1-DAY POST-OP (VISION 20/25) AND 7-DAY POST-OP (VISION 20/40). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Corneal Edema; No Code Available

  MAUDE report 7999996 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.0 DIOPTER 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 DISSATISFIED AND EXPERIENCED HALOS/GLARE/DECREASED COLOR CONTRAST. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZCB00 22.5 DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7800041 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED OF A TEMPORAL FLASHING ARC, FOREIGN BODY SENSATION, AND POOR INTERMEDIATE AND NEAR VISION. REPORTEDLY, THE PATIENT FEELS SHE IS ''SEVERELY HAMPERED BY POOR VISION''. THE PATIENT'S SYMPTOMS SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Sensation in Eye; Visual Disturbances; Visual Impairment

  MAUDE report 7779257 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE, (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT COMPLAINED OF FOGGY VISION FROM DAY ONE AFTER SURGERY, WITH CHRONIC NIGHT GLARE, AND SMOKEY VISION. REPORTEDLY, THE PATIENT NEVER HAD A BETTER VISUAL ACUITY THAN 20/30 AND HAD A YTTRIUM-ALUMINUM GARNET (YAG) CAPSULOTOMY AND A PHOTOREFRACTIVE KERATECTOMY (PRK) PERFORMED. ANATOMICALLY, EVERYTHING LOOKED JUST FINE. THE REPLACEMENT LENS WAS A NON-AMO LENS. THERE WAS A VITRECTOMY PERFORMED AS WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 7291274 ↗
• InjuryNov 27, 2017Adverse 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 FROM THE RIGHT EYE OF A FEMALE PATIENT BECAUSE OF A MECHANICAL FAILURE. REPORTEDLY, THE INCISION WAS ENLARGED TO 4 MILLIMETERS, THE OPTIC WAS REMOVED WHOLE AND A VITRECTOMY WAS PERFORMED. NO SUTURES WERE USED AND NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND CLARIFIED THAT MECHANICAL FAILURE MEANT THAT THE PATIENT FAILED TO ADAPT TO THE MULTIFOCAL OPTIC. THE PATIENT REPORTED BLURRY VISION IMMEDIATELY AFTER SURGERY. AFTER THE EXPLANT THE PATIENT WAS REPORTED DOING GREAT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 7062292 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO THE PATIENT NOT BEING HAPPY WITH UNRESOLVED EXPERIENCES OF HALOS AND GLARE. THE REPLACEMENT LENS WAS A ZCB00, BUT THE DIOPTER WAS NOT PROVIDED. THE LENS WAS DISCARDED AND WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7047465 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (ZLB00 +22.0 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF THE PATIENT COMPLAINING ABOUT HALOS AND GLARE. A MONOFOCAL LENS (MODEL AR40E +22.0 DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6799705 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, AFTER IMPLANTATION OF A ZLB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) IN A PATIENT'S RIGHT EYE, THE PATIENT IS VERY UNHAPPY WITH THEIR VISUAL ACUITY AND HAS REQUESTED FOR THE LENS TO BE EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6716108 ↗
• InjuryMay 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED RECEIVING BILATERAL IMPLANTS WITH ZLB00 INTRAOCULAR LENSES (IOLS) A FEW MONTHS AGO AND SHE LOVES THEM. THE ONLY PROBLEM IS THE HALOS WHILE DRIVING AT NIGHT. SHE COMMENTED THAT HER VISION IS DEFINITELY AS GOOD AS IT WAS RIGHT AFTER SURGERY. FOLLOW-UP WITH THE CLINIC CONFIRMED THAT THE PATIENT IS COMPLAINING OF HALOS AT NIGHT, BUT THE PHYSICIAN HAS NO PLANS ON EXPLANTING THE LENS. THE PATIENT WAS GIVEN VERY MINIMAL PRESCRIPTION GLASSES TO HELP WITH THE HALOS. THIS LENS WILL CAPTURE THE LENS IMPLANTED ON THE RIGHT EYE. A SEPARATE MDR REPORT WILL BE FILED FOR THE LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 6556093 ↗
• MalfunctionMar 31, 2017Kinked; Kinked

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OBSERVED TO BE KINKED/CRIMPED DURING HANDLING BUT PRIOR TO INSERTION. NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6450605 ↗
• InjuryMar 20, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZLB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE. ACCORDING TO THE PHYSICIAN THE IOL WAS DECENTERED SECONDARY TO POSTERIOR CHAMBER OPENING. THERE WAS NO INJURY OR SUTURES REQUIRED FOR THIS EVENT, HOWEVER, VITRECTOMY WAS REQUIRED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 6416478 ↗
• InjuryMar 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 22.0 INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE SURGERY RESULTS. THE LENS WAS REPLACED WITH A ZCB00 IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6405056 ↗
• InjuryMar 7, 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 POST OPERATIVE HYPEROPIA. THE LENS WAS REPLACED WITH ANOTHER MULTI-FOCAL LENS, A 23.0 DIOPTER, MODEL ZKB00 LENS. THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. NO INCISION ENLARGEMENT WAS REQUIRED. THE EXPLANTED LENS IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6383040 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT A FEMALE PATIENT WAS REPORTED THAT HER "EYES SWIMMING'' AND HAD ALSO EXPERIENCED NAUSEA AFTER IMPLANTATION OF ZLB00 MULTIFOCAL INTRAOCULAR LENSES (IOL). PATIENT IS SEEING 20/20 AT ALL DISTANCES. THE PHYSICIAN INDICATED THAT HE DOES NOT THINK IT IS RELATED TO THE IOLS. THE PATIENT DESCRIBE THE SYMPTOM AS "A BOOK THAT CAN BE FLIPPED AND IT MAKES A MOVIE". IT SEEMED LIKE SHE WAS SEEING FRAME BY FRAME LIKE A MOVIE. THE PHYSICIAN TRIED MANY THINGS INCLUDING PRESCRIBING PILOCARPINE TO ADDRESS THE PATIENT'S SYMPTOMS, BUT THEY WERE UNSUCCESSFUL. THE PHYSICIAN NOTED THAT PATIENT WAS ORTHOPHORIC IN PRIMARY GAZE WITHOUT DIPLOPIA. THE SYMPTOMS ONLY OCCURS WHEN SHE LOOKED FROM SIDE TO SIDE. THE SYMPTOMS RESOLVED AFTER THE PHYSICIAN EXPLANTED THE LENS FROM BOTH EYES AND REPLACED THEM WITH MONOFOCAL LENSES. PATIENT IS STILL 20/20 AT DISTANCE. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. THERE WAS NO PATIENT INJURY. THE LENS IS NOT AVAILABLE FOR RETURN AS IT WAS THROWN AWAY AFTER THE LENS WAS EXPLANTED. THIS REPORT WILL CAPTURE THE LENS EXPLANTED FROM THE RIGHT EYE AND A SEPARATE MDR WILL BE FILED FOR EXPLANT FROM THE LEFT EYE.

  Patient problems: Nausea; No Code Available

  MAUDE report 6260686 ↗
• InjuryJan 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED AND EXCHANGED WITH A NON AMO LENS. THE REASON FOR EXPLANT WAS NOT PROVIDED. THERE WAS NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6248510 ↗