TECNIS IOL ZLB00 (REF ZLB00U0230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05050474560734), received between Aug 23, 2016 and Jun 22, 2025 — classified as 27 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. 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 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BILATERAL INTRAOCULAR LENS (IOL) EXCHANGES WERE PERFORMED. POST IOL IMPLANTATION THE PATIENT WAS OBSERVED WITH PSEUDOPHAKIA OF BOTH EYES (OU). THE PATIENT REPORTED EXPERIENCING SIGNIFICANT DISCOMFORT, INCLUDING HALOING AROUND LIGHTS, DRYNESS, AND DIFFICULTY DRIVING AT NIGHT DUE TO HALOS. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT CAPTURES THE ISSUES REPORTED WITH THE LENS SN (B)(6) FOR THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S LEFT EYE.

  Patient problems: Dry Eye(s); Halo

  MAUDE report 22304650 ↗
• InjuryDec 9, 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 RIGHT EYE DUE TO "WRONG POWER". ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZLU225, SAME DIOPTER OF 23.0). THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15954237 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S WIFE CALLED TO EXPLAIN THAT HER HUSBAND HAD AN INTRAOCULAR LENS (IOL) IMPLANTED IN HIS LEFT EYE. SINCE THE DAY OF IMPLANT HE'S EXPERIENCED BLURRY VISION, WHICH THEY BROUGHT TO THEIR DOCTOR'S ATTENTION. HOWEVER, HER HUSBAND HAS SEEN SEVERAL DOCTORS AT THIS FACILITY OVER THE LAST TWO YEARS TRYING TO ASCERTAIN THE ISSUE. THEY WERE ADVISED BY THEIR REGULAR DOCTOR TO SEEK A SECOND OPINION. REPORTEDLY, HER HUSBAND HAS HAD AN MAGNETIC RESONANCE IMAGING (MRI) AND HAS BEEN TESTED FOR SEVERAL THINGS INCLUDING BRAIN ISSUES BUT THIS WAS RULED OUT AS HAVING AN IMPACT ON HIS VISION. THE FOURTH AND MOST RECENT DOCTOR CONDUCTED A "LASER CLEANING" ON THE EYE IN HOPES THAT THE VISION WOULD IMPROVE. HIS VISION IMPROVED BUT NOT TO THE LEVEL HE HAD ANTICIPATED. THE DOCTOR ADVISED THEM TO CALL JOHNSON AND JOHNSON (JNJ) AND ASK IF THE IOL HAD A RECALL OR IF WE HAD SEEN THIS ISSUE BEFORE. THE CUSTOMER CALLED JNJ AND ASKED FOR ADVISE ON HOW TO PROCEED. THE JNJ REPRESENTATIVE WHO INITIALLY SPOKE TO HER INFORMED HER TO FOLLOW-UP WITH THEIR DOCTOR. ADDITIONAL FOLLOW-UP WAS DONE BUT THE CUSTOMER DID NOT RESPOND. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 11803568 ↗
• InjuryMay 7, 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 IMPLANTED IN THE PATIENT'S LEFT EYE AND THE PATIENT WAS NOT HAPPY AS PATIENT COULD NOT FOCUS CORRECTLY ESPECIALLY WHEN DRIVING. THE PATIENT ALSO COMPLAINED VISION WAS BLURRY, HAZY, AND COLORS WERE NOT RIGID. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 10037097 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE AND THE PATIENT WAS NOT HAPPY AS PATIENT COULD NOT FOCUS CORRECTLY ESPECIALLY WHEN DRIVING. THE PATIENT ALSO COMPLAINED VISION WAS BLURRY, HAZY, AND COLORS WERE NOT RIGID. THE VISUAL ISSUES BECAME BOTHERSOME TWO MONTHS POST-IMPLANT. THE PATIENT WAS INTOLERANT TO THE MULTIFOCAL LENS EXACERBATED BY ASTIGMATISM CAUSED BY THE FLATTENING FROM THE FEMTOSECOND LASER ARC. A VITRECTOMY WAS REQUIRED AS WELL AS LIMBAL RELAXATION INCISIONS, HOWEVER, THERE WAS NO PATIENT INJURY. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT'S VISION HAS IMPROVED. THE GLARE AND HALOS HAVE DECREASED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9874406 ↗
• InjuryMar 12, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO MECHANICAL FAILURE. INCISION ENLARGEMENT ALONG WITH SUTURE WAS USED. THERE WAS NO COMPLICATION OR PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9823952 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A ZLB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO UNKNOWN REASONS. THROUGH FOLLOW-UP THE CUSTOMER EXPLAINED THAT THE PATIENT COMPLAINED OF FOGGY VISION AT HER ONE DAY POST OPERATIVE VISIT AND THERE EVER AFTER, ALSO GLARE, HAZINESS, AND UNABLE TO TOLERATE LENS. PER THE DOCTOR'S OPINION HE DOES NOT THINK THERE IS ANYTHING WRONG WITH THE JOHNSON & JOHNSON IOL. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 9724635 ↗
• InjuryDec 30, 2019Compatibility Problem; Compatibility Problem

  IT WAS REPORTED ZLB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2019. THE ZLB00 LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO THE PATIENT'S INCOMPATIBILITY WITH THE IOL. IT WAS REPORTED THERE WAS NO REQUIRED MEDICAL AND/OR SURGICAL INTERVENTION AND THE ZLB00 23.0 DIOPTER IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. PATIENT OUTCOME WAS REPORTED AS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9533631 ↗
• InjurySep 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE (OD). THE PATIENT IS UNHAPPY WITH HER VISION AS IT IS BLURRY AND UNSTABLE. SHE REQUESTED EXPLANT OF BOTH LENSES WITH REPLACEMENT WITH MONOFOCAL IOL''S. FURTHER FOLLOW-UP CONFIRMED THAT BOTH LENSES REMAIN IMPLANTED AND THAT THE PATIENT IS DISSATISFIED. THE PATIENT STILL HAS BLURRY VISION, DESCRIBED AS NOT SEEING CLEARLY. THE PATIENT HAS A MODEL ZXR00 IN THEIR LEFT EYE (OS) AND A MODEL ZLB00 IN THEIR RIGHT EYE (OD). NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8972970 ↗
• InjuryJun 26, 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 AND EXCHANGED FOR AN MODEL ZA9003 IOL. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION BUT TO DATE NOT RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8737677 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00, 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. THERE WAS NO POST-OP INJURY. REPLACEMENT LENS WAS ANOTHER ZLB00 OF A HIGHER DIOPTER (23.5). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8177808 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00, 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. THERE WAS NO POST-OP INJURY. REPLACEMENT LENS WAS ANOTHER ZLB00 OF A HIGHER DIOPTER (24.0). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8177771 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +23.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING HALOS AND GLARE. AN NON-JOHNSON & JOHNSON SURGICAL VISION, INC. LENS WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO INCISION ENLARGEMENT, VITRECTOMY OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED TO BE DOING FINE WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7384426 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT STATES THEIR VISION IS NOT WHAT THEY EXPECTED AND THE PATIENT CAN ONLY COUNT FINGERS, WHICH HAS NOT IMPROVED. REPORTEDLY, THERE WERE NO COMPLICATIONS AND THE SURGEON DOES NOT PLAN TO EXPLANT THE LENS AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7181249 ↗
• InjurySep 15, 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 IN A SECONDARY SURGICAL PROCEDURE AS THE PATIENT HAD BLURRED VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6870712 ↗
• InjurySep 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO COMPLAINTS ABOUT VISUAL DISTURBANCE AND LOSS OF DISTANCE VISION, INCLUDING THE PATIENT NOT BEING HAPPY WITH THE LENS IMPLANT. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT A LOWER DIOPTER SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6863857 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, AFTER IMPLANTATION OF A ZLB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) IN A PATIENT'S LEFT EYE, THE PATIENT IS VERY UNHAPPY WITH THEIR VISUAL ACUITY AND HAS REQUESTED THE LENS TO BE EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6716062 ↗
• InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +23.0 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE RIGHT EYE OF A FEMALE PATIENT BECAUSE OF A REFRACTIVE ERROR. NO INCISION ENLARGEMENT, NO SUTURE USED AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6596078 ↗
• InjuryMay 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZLB00 23.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT EXPERIENCING STARBURST. THE PHYSICIAN FEELS THERE MAY BE A DEFECT IN THIS LENS WHICH IS CAUSING UNUSUAL GLARE. FURTHER CLARIFICATION WAS PROVIDED BY THE PHYSICIAN THAT THE DEFECT WAS IN A STARBURST THAT SHE WAS HAVING IN THAT EYE THAT WAS NOT CORRECTABLE WITH REFRACTION OR ANY OTHER TREATMENT. NO OTHER PATHOLOGY IN THIS EYE. DEFECT WAS NOT VISIBLE. THERE WAS A CAPSULE TEAR AND VITRECTOMY PERFORMED AND THE INCISION WAS ENLARGED WHEN REMOVING THE LENS. THE PATIENT IS DOING WELL BUT THE REFRACTION HAS NOT YET SETTLED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Capsular Bag Tear; Corneal Scar; No Code Available; Pain; Visual Disturbances; Visual Impairment; Vitrectomy

  MAUDE report 6557530 ↗
• InjuryMar 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 23.0 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENTS EYE DUE TO A REFRACTIVE SURPRISE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 24.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6448227 ↗
• InjuryMar 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO DYSPHOTOPSIA. THE PATIENT WAS EXPERIENCING HALOS AND GLARE. IT WAS ALSO REPORTED THAT THE LENS WAS REPLACED WITH A ZCT300, MONOFOCAL IOL AND THE PATIENT IS DOING FINE.

  Patient problems: Halo; No Code Available

  MAUDE report 6437789 ↗
• 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 LEFT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S RIGHT EYE.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 6207942 ↗
• InjuryDec 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A MODEL ZLB00 INTRAOCULAR LENS (IOL) IN BOTH EYES, PATIENT HAS BEEN HAVING VISUAL ISSUES WITH THEM MORE OR LESS SINCE AFTER SURGERY DATE. HE HAD BOTH IOLS IMPLANTED ON (B)(6) 2016. REPORTEDLY, PATIENT EXPERIENCED BLURRY VISION AND HALOS/GLARES MORE IN THE EVENING HENCE HE CANNOT DRIVE WELL. HE IS ALSO HAVING HEADACHES, EYES ARE SORE/SQUEEZING PAIN. SYMPTOMS ARE MORE PROMINENT IF THERE IS LIGHT. ACCORDING TO PATIENT, HE HAS BEEN GOING TO SEVERAL DOCTORS ALREADY AND THEY ALL SAID THAT THERE MUST BE SOMETHING WRONG BUT COULDN'T PINPOINT EXACTLY WHAT; THE PATIENT IS FRUSTRATED BECAUSE HE CANNOT WORK AS A DENTIST ANYMORE. 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; Halo; Headache

  MAUDE report 6207741 ↗
• InjuryDec 2, 2016Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) IS PLANNED TO BE EXPLANTED AND REPLACED WITH A ZMB00 IOL TO IMPROVE PATIENT'S NEAR VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6143426 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS, MODEL ZLB00, WAS EXPLANTED DUE TO AN UNEXPECTED POST-OP REFRACTION. THE LENS WAS REPLACED WITH A ZCB00 WITH A 24.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE AND NO PATIENT POST-OP INJURY.

  Patient problems: No Code Available

  MAUDE report 5975285 ↗