TECNIS IOL ZLB00 (REF ZLB00U0240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474560758), received between Aug 22, 2016 and Jun 14, 2024 — classified as 18 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 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 (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. THE LENS WAS REPLACED AS THE PATIENT WAS SUFFERING FROM SEVERE GLARES AND HALOS AND COULD NOT TAKE THE DIFFRACTIVE PROPERTIES OF THE LENSES. NO OTHER ISSUES WERE PRESENT THAT CAUSED AN ISSUES WITH THE LENS. THERE WERE NO SURGICAL COMPLICATIONS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19543319 ↗
• InjuryApr 23, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THE ZLB00 MODEL INTRAOCULAR LENS (IOL) WAS PARTIALLY IMPLANTED DUE TO PATIENT HAVING INCREASED OCULAR PRESSURE (IOP). ANOTHER ZLB00 24.0 DIOPTER IOL WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT WAS GIVEN ALPHAGAN DROP AND DIAMOX SEQUELS TO REDUCE IOP THAT PERSISTED UNTIL THE NEXT DAY. PATIENT DID NOT EXPERIENCE ANY VISUAL ISSUES DUE TO IOP. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), NO VITRECTOMY, AND NO SURGICAL COMPLICATIONS. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS DOING WELL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19169811 ↗
• InjuryNov 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THEM EXPERIENCING HALOS, GLARE AND MECHANICAL ISSUES. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL DCB00 23.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE PATIENT POST-OP IS HAPPY AT 20/20 VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15850283 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SPIDER WEB VISION AND BLURRED VISION WITH AN INTRAOCULAR LENS (IOL) IN BOTH EYES. THE PATIENTS DISTANT VISION IS GOOD, HOWEVER, CLOSE-UP VISION IS HORRIBLE. THE PATIENT IS USING A MAGNIFYING GLASS JUST TO READ. THROUGH FOLLOW-UP, IT WAS LEARNED VISON IS GOOD FAR AWAY, VISION MID-RANGE IS MUCH BETTER, HOWEVER, CLOSE-UP IS DISAPPOINTING BECAUSE SHE HAS TO WEAR GLASSES TO DO PUZZLES. PATIENT IS NOT HAPPY SHE HAS TO WEAR GLASSES AS SHE WAS TOLD SHE WILL NOT NEED GLASSES. THE PATIENT CLARIFIED THAT HER SPIDER WEB VISION WAS MORE OF A FIXED LOCATION ISSUE. AFTER SHE RECEIVED THE LASER TREATMENT, IT SOMEWHAT IMPROVED A LITTLE. THE PATIENT HAS HAD LASER TREATMENTS DONE ON BOTH OF HER EYES WHICH ALSO FIXED THE CLOUDINESS, BUT DID NOT FIX HER VISION ISSUES. VISION IS STILL FUZZY. NO DATES WERE PROVIDED FOR THE LASER TREATMENT NOR THE TYPE OF LASER TREATMENT WAS PROVIDED. THE PATIENT CONFIRMED HER VISUAL ISSUE IS NOT DEBILITATING. THE PATIENT IS ABLE TO DO DAILY ACTIVITIES, HOWEVER, VISUAL ISSUES ARE BOTHERSOME. AT THIS TIME, THE LENSES REMAIN IMPLANTED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS R

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11988241 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SEES HALOS, BRIGHT LIGHT, HAS DOUBLE VISION, AND IS NOT ABLE TO DRIVE WITH AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT HAS BEEN HAVING SEVERE ISSUES WITH SEEING HALOS AT NIGHT, LOOKING AT THE LIGHT AND/OR TV. THE PATIENT CANNOT DRIVE ANYMORE AND IS NOT HAPPY WITH HER VISION. A LASER TREATMENT WAS PERFORMED SOMETIME IN (B)(6) 2020 OR (B)(6) 2021, BUT THE EXACT TIMEFRAME IS UNKNOWN. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; Visual Impairment

  MAUDE report 11617856 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT AFTER HIS BILATERAL SURGERIES IN 2018, HIS EYES WOULD CLOSE ON HIM CONTINUOUSLY AND IT IS A STRUGGLE TO KEEP THEM OPEN WHILE DRIVING. THE PATIENT IS LIGHT SENSITIVE AND INDICATED THAT HIS EYES KEEP CLOSING EVEN WHEN HE IS IN A SHADED ENVIRONMENT, NOT EXPOSED TO LIGHTS. THE PATIENT ALMOST QUIT DRIVING BECAUSE OF HIS SYMPTOMS. AFTER HIS SURGERY, THE PATIENT INFORMED HIS DOCTOR OF THE SYMPTOMS, BUT THE DOCTOR DID NOT RESPOND TO HIS COMPLAINT AT THE TIME AND TOLD HIM TO COME BACK AFTER ONE YEAR. THE PATIENT NEEDED TO RETIRE AS HE IS (B)(6) AND STILL FEELS LIKE HE HAS ENERGY TO KEEP GOING, BUT THIS PROBLEM IS HURTING HIM. THE PATIENT HAS ORDERED UV PROTECTION SUNGLASSES WHICH USES THEM. THE PATIENT MADE AN APPOINTMENT TO SEE A SPECIALIST ON (B)(6) 2021, THIS WOULD BE HIS SECOND APPOINTMENT. THE FIRST TIME, THE PATIENT WAS TOLD THAT HE HAS DRY EYE AND WAS PRESCRIBED WITH THERA TEARS (1DROP/4TIMES A DAY) WHICH HE SOMETIMES USES IT EVEN MORE THAT 4 TIMES/DAY. THE PATIENT INDICATED THAT HE DID NOT HAVE ANY DRY EYE ISSUES BEFORE HIS CATARACT SURGERIES. THE PATIENT NOTED THAT THE DROPS DID NOT HELP WITH HIS SYMPTOMS. THE DOCTOR STATED THAT THE PATIENT¿S EYES ARE LAZY W

  Patient problems: Dry Eye(s); Visual Disturbances

  MAUDE report 11305822 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO MULTIFOCAL LENS INTOLERANCE. AT DAY ONE POST-IMPLANT THE PATIENT WAS NOT HAPPY WITH VISION. THE LENS WAS EXCHANGED WITH WOUND REVISION, AND THE REPLACEMENT LENS IS A ZA9003 23.5 DIOPTER LENS. POST-EXCHANGE THE PATIENT STATED COLORS ARE MUCH BRIGHTER, VISION IS BLURRY BUT BETTER DAY ONE POST-OP. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, OR VITRECTOMY, NOR SUTURES REQUIRED. THE PATIENT WENT BACK TO REFERRING DOCTOR FOR FOLLOW-UP CARE. NO OTHER POST-OP DATA TO REPORT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11196246 ↗
• InjurySep 22, 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 REMOVED FROM THE PATIENT'S EYE DUE TO A RESIDUAL REFRACTIVE ERROR. THE LENS WAS REPLACED WITH ANOTHER ZLB00 LENS, WITH A DIFFERENT POWER. IT WAS NOTED THAT NO PRODUCT WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9101438 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH TECNIS MULTIFOCAL INTRAOCULAR LENS IN BOTH THE EYES. REPORTEDLY PATIENT WAS DISSATISFIED WITH THE LENS AND AFTER MAKING MULTIPLE ATTEMPTS TO IMPROVE PATIENT¿S VISION, PATIENT REMAINS UNHAPPY. PATIENT IS REFUSING THE LENS EXPLANT. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S ONE EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR PATIENT¿S ANOTHER OPERATIVE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8975636 ↗
• 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 WAS IMPLANTED INTO THE PATIENTS RIGHT EYE. THE LENS WAS SUBSEQUENTLY EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8913914 ↗
• MalfunctionMar 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE OF THE PATIENT, THE SURGEON NOTICED A ¿CHIP¿ ON THE EDGE OF THE LENS. REPORTEDLY, THE SURGERY WAS COMPLETED WITHOUT INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT IS DOING WELL AND THERE IS NO NEED TO EXPLANT THE IOL. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356144 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00, 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE (OD) DUE TO BLURRY VISION WHICH AFFECTED HER DRIVING AND READING. PATIENT INDICATED THAT HER VISION WAS BETTER BEFORE THE SURGERY. THE VISUAL ACUITY (VA) OF THE PATIENT WAS REPORTED TO BE 20/60. THE LENS WAS REPLACED WITH A MODEL ZKB00 (25.0 DIOPTER) LENS. THERE WAS NO PATIENT CONTRIBUTING MEDICAL HISTORY REPORTED. THERE WAS NO PATIENT INJURY REPORTED, NO INCISION WAS ENLARGED, AND NO OTHER SECONDARY PROCEDURE WAS REQUIRED. THE PATIENT POST-OP CONDITION IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7278703 ↗
• InjuryFeb 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO THE PATIENT COMPLAINING OF BLURRY VISION AND SEVERE HALO/GLARE. THE LENS WAS REPLACED WITH A ZCB00 25.0 DIOPTER IOL. REPORTEDLY, THE PATIENT'S POST-OPERATIVE END REFRACTION WAS 20/30 -0.25 X -.025 X 157 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 7237866 ↗
• InjuryDec 5, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO A POST-LASIK PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO POOR VISUAL ACUITY OBSERVED AT THE PATIENT'S 1 WEEK POST-OPERATIVE VISIT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 22.0. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7085548 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 24.0 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017, BUT LATER EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6916362 ↗
• InjuryAug 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT FOLLOWING A CATARACT EXTRACTION WITH A TECNIS 1 MULTIFOCAL (TMF) MODEL ZLB00 INTRAOCULAR LENS (IOL) PROCEDURE, A PATIENT EXPERIENCED DRY EYE, GLARE AND HALOS. A DESCRIPTION FROM THE PATIENT INDICATED THAT CATARACT PROCEDURE FOR BOTH EYES (OU) WAS PERFORMED IN (B)(6) 2016. ALTHOUGH, THE PATIENT WAS NO LONGER DEPENDENT ON GLASSES, DRY EYE HAD DEVELOPED AND HAD MAJOR PROBLEMS WITH GLARE AND HALOS IMMEDIATELY AFTER THE PROCEDURE AND COULD NOT DRIVE AT NIGHT. THE SURGERY CENTER PERFORMED A YAG PROCEDURE ON OU TO RESOLVE THE HALOS AND GLARE. THE PATIENT COMMENTED THAT THE YAG PROCEDURE HAD NO EFFECT ON RELIEVING THE GLARE OR HALOS. THE DRYNESS WAS ADDRESSED WITH PERMANENT LOWER PUNCTAL PLUGS IN BOTH EYES AND RESTASIS WAS PRESCRIBED IN (B)(6) 2016. THE PATIENT NOTED ON USING RESTASIS AND PUNCTAL PLUGS INSERTED HAD GREATLY HELPED WITH THE DRY EYES. THE PATIENT INDICATED THE PROBLEMS/SYMPTOMS THAT HAD DEVELOPED HAVE GREATLY IMPEDED THE ABILITY TO DRIVE AFTER DARK AND RECENTLY HAVING ISSUES WITH A WAX PAPER LIKE VISION DURING THE DAY. THE SURGERY CENTER INDICATED THERE IS NO PLAN TO EXPLANT THE LENSES AND THE PATIENT WAS LAST SEEN ON (B)(6) 2017. THE SURGEON EXPLAI

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

  MAUDE report 6757533 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CATARACT SURGERY ON (B)(6) 2015. A ZLB00 WAS IMPLANTED WITH NO COMPLICATIONS. HOWEVER, PATIENT IS UNHAPPY WITH HER OVERALL QUALITY OF HER VISION AND IS COMPLAINING OF BLURRED VISION AT ALL DISTANCE. PATIENT IS ALSO EXPERIENCING PHOTOPHOBIA. THE PHYSICIAN PRESCRIBED CORRECTIVE LENSES AND TREATED THE PATIENT FOR DRY EYES, BUT THE PATIENT IS STILL UNHAPPY WITH HER VISION. ACCORDING TO THE FOLLOW UP, THE PHYSICIAN DOES NOT PLAN TO REMOVE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 6647387 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING BLURRED VISION AFTER CATARACT SURGERY. THE PATIENT IS ALSO EXPERIENCING GLARE AND HALO'S THAT AFFECT THEIR VISION WHEN READING FROM THE COMPUTER AND RECOGNIZING FACES. IT WAS NOTED THAT THE PATIENT'S VISUAL ACUITY WAS 20/50. THE LENS WAS REPLACED WITH THE SAME MODEL LENS BUT A 25.0 DIOPTER. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. THERE WAS NO POST-OP INJURY REPORTED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6423112 ↗
• InjuryAug 22, 2016Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED IN THE RIGHT EYE (OD) OF A FEMALE PATIENT DUE TO DOCTOR HAD TO CHANGE DIOPTER POWER. THE IOL WAS REPLACED WITH A SAME MODEL BUT DIFFERENT DIOPTER 20.0 IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5894963 ↗