TECNIS IOL ZLB00 (REF ZLB00U0235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05050474560741), received between Sep 13, 2016 and May 18, 2026 — classified as 31 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EXPLANT PROCEDURE WAS PERFORMED INVOLVING A SINGLE-PIECE SPHERICAL MULTIFOCAL INTRAOCULAR LENS (IOL) FROM THE PATIENT¿S LEFT EYE FOR UNSPECIFIED REASONS, AND THE ORIGINAL LENS WAS REPLACED WITH A SINGLE-PIECE TORIC II IOL OF THE SAME DIOPTER DURING A SECONDARY SURGERY; THE EVENT WAS OBSERVED DURING IMPLANTATION/APPLICATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25211611 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO HER RIGHT AND LEFT EYE. THE PATIENT REPORTED EXPERIENCING BLURRY VISION AFFECTING ALL RANGES OF VISION, WITH THE ISSUE BEING MORE PRONOUNCED IN THE RIGHT EYE. SHE HAS UNDERGONE A SUBSEQUENT LASIK SURGERY. HER RIGHT EYE WAS IMPLANTED (B)(6) 2022. HOWEVER, THE BLURRINESS BEGAN APPROXIMATELY 2-3 MONTHS AGO FROM THE DATE THIS EVENT WAS REPORTED TO JNJ WHICH IS (B)(6) 2025. REPORTEDLY, THERE WERE NO CHANGES TO HER OVERALL HEALTH DURING THIS TIME. PRIOR TO THE ONSET OF SYMPTOMS, SHE DESCRIBED HER VISION AS EXCELLENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE RIGHT EYE MANUFACTURER REPORT NUMBER . THE LEFT EYE IS REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0002059.

  Patient problems: Blurred Vision

  MAUDE report 22683277 ↗
• 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 LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE.

  Patient problems: Dry Eye(s); Halo

  MAUDE report 22304649 ↗
• InjurySep 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO SEVERE POSITIVE DYSPHOTOPSIA, CANNOT DRIVE AT NIGHT, TEMPORARILY IMPAIRED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO DELAY IN PROCEDURE. THE EXPLANTED LENS IS NOT BEING RETURNED. THE PATIENT IS PEREMPTORILY IMPAIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 20164689 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) (ZLB00, 23.5 DIOPTER) WAS EXPLANTED FROM THE LEFT EYE FOR AN UNKNOWN REASON. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (ZCB00, 25.5 DIOPTER), WHICH RESULTED IN A CAPSULE TEAR. THE ZCB00 REPLACEMENT LENS WAS IMMEDIATELY REMOVED FROM THE LEFT EYE AND A VITRECTOMY WAS PERFORMED. A 3-PIECE NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR THE ZLB00 IOL. A SEPARATE REPORT WILL CAPTURE THE EVENT FOR THE ZCB00 IOL.

  Patient problems: Eye Injury

  MAUDE report 19952083 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT COULD NOT TOLERATE THE NIGHTTIME GLARE AND HALOS AND COMPLAINED OF WAXY VISION. THE LENS WAS EXPLANTED ON (B)(6) 2024 AND REPLACED WITH AN LAL IOL. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. PATIENT STATUS IS FULLY RECOVERED. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 19483193 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIGNIFICANT ATTEMPTS WERE MADE OVER THE PAST TWO YEARS TO IMPROVE THE PATIENT¿S OCULAR SURFACE (DRY EYES) VIA PRESCRIPTION EYEDROPS AND IPL/LIPIFLOW COMBINATION, AND SEVERAL AMNIOTIC MEMBRANE PLACEMENTS. ALSO, A YAG (YTTRIUM ALUMINUM GARNET) CAPSULOTOMY WAS PERFORMED ON BOTH EYES (OU) AND A LASIK PROCEDURE IN THE LEFT EYE (OS) ONLY WAS PERFORMED TO TREAT MINIMAL REFRACTIVE ERROR. NONE OF THESE MEASURES PROVED SUCCESSFUL IN ALLEVIATING THE PATIENT¿S COMPLAINTS AS THEY ARE RELATED TO POOR VISUAL QUALITY AND GLARE, PARTICULARLY OF HIS LEFT EYE. AFTER CAREFUL EVALUATION, CUSTOMER PURSUED SUSPECT LENS EXPLANT PROCEDURE TO ACHIEVE SYMPTOM RELIEF. SO FINALLY, AN EXCHANGE WAS PERFORMED TO REMOVE LENS FORM THE PATIENT'S LEFT EYE DUE TO POOR SUBJECTIVE VISION QUALITY AT ALL DISTANCES DESPITE REFRACTIVE TOUCH UP AND YAG CAPSULOTOMY. A 3-PIECE, 23.0 DIOPTER SIZE NON-JOHNSON AND JOHNSON LENS WAS IMPLANTED IN THE SULCUS WITH OPTIC CAPTURE. AT THE TIME OF THE EXPLANT PROCEDURE INCISION ENLARGEMENT WAS DONE (SIMPLY TO ACCOMMODATE THE 3PC IOL CARTRIDGE) AND A SINGLE SUTURE FOR THE PRIMARY INCISION. THE PATIENT OUTCOME, POST-OP DAY-1 VISUAL ACUITY 20/40 PH 20/30 DOING WELL WITH

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 15299259 ↗
• InjuryDec 29, 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 EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO VISUAL DISTURBANCE. THE LENS WAS CUT AND REMOVED FROM THE EYE WITHOUT INCISION ENLARGEMENT. NO VITRECTOMY OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 11092710 ↗
• InjuryOct 23, 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 EXPLANTED DUE TO INCOMPATIBILITY. IT WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. PATIENT WELL POST-EXCHANGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10723789 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE BILATERAL LENS IMPLANTS. THE LEFT EYE WAS IMPLANTED ON (B)(6) 2020 WITH A MODEL ZLB00 LENS AND IS THE ONE GIVING HER ISSUES. SHE FEELS SHE CAN¿T READ THE WAY SHE ANTICIPATED. SHE HAD MODEL ZXR00 IMPLANTED HER RIGHT EYE ON (B)(6) 2020 AND CAN SEE FINE WITH IT. SHE COULD READ FINE DIRECTLY AFTER SURGERY, HOWEVER IT STARTED TO DETERIORATE AFTER, TO WHERE SHE DOESN¿T HAVE THE SHARPNESS SHE ORIGINALLY EXPERIENCED. SHE SAID HER EYE FEELS HEAVY, BUT THERE IS NO PAIN. SHE SAID IT FEELS CLOUDY, OR SLIGHTLY BLURRED. SHE HAS SEEN HER SURGEON TWICE, AND THE SURGEON SAID IT LOOKS OK AND WANTS TO LOOK AT IT AGAIN AT 3-MONTHS AND WILL EVALUATE WHETHER SHE WILL NEED A LASER ADJUSTMENT TO ADDRESS ANY SCAR TISSUE THAT MAY HAVE DEVELOPED. THE IMPLANTING SURGEON MOVED, BUT SHE WENT TO OTHER SURGEON IN SAME FACILITY WHO SAID TO PUT A WARM CLOTH ON IT. SHE WAS TOLD SHE HAS DRY EYE AND WAS RECENTLY PRESCRIBED RESTASIS. SHE SAID WHEN SHE USES REFRESH EYE DROPS, MAKES IT FEEL A LITTLE BETTER BUT IT DOESN¿T IMPROVE SHARPNESS. SHE HAS MILD HYPERTENSION, BUT DOESN¿T FEEL IT SHOULD IMPACT THIS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT PATIENT¿S N

  Patient problems: Blurred Vision; Therapeutic Effects, Unexpected

  MAUDE report 10280473 ↗
• InjuryJun 8, 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 EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT WAS NOT HAPPY WITH VISION. THE PATIENT COULD NOT ADJUST TO THE LENS, EXPERIENCED BLURRINESS, AND VISUAL DISTURBANCE. THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

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

  MAUDE report 10130918 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A ZLB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS SCHEDULED FOR EXPLANT FROM THE PATIENT¿S LEFT EYE DUE TO THE PATIENT¿S DISSATISFACTION WITH THEIR NEAR AND DISTANCE VISION. THE REPLACEMENT LENS IS INDICATED TO BE A ANOTHER ZLB00 IOL, BUT HIGHER DIOPTER 25.0. THROUGH FOLLOW-UP THE DOCTOR CONFIRMED THE EXPLANT WAS CONDUCTED AS SCHEDULED, AND EVERYTHING WENT WELL. THERE WAS NO VITRECTOMY OR ANY OTHER INTERVENTION. THE PATIENT IS FINE POST-EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9589531 ↗
• InjuryJan 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MECHANICAL FAILURE. AT EXPLANT AN INCISION ENLARGEMENT WAS REQUIRED, AND THE LENS WAS REMOVED IN ONE PIECE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9542083 ↗
• InjurySep 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ZLB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2019. IOL WAS EXPLANTED (B)(6) 2019 DUE TO COMPLAINT OF DISLOCATED LENS. ZLB00 23.5 DIOPTER LENS WAS REPLACED WITH A ZLB00 24.5 DIOPTER LENS. IT WAS REPORTED THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8959528 ↗
• InjuryAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REFRACTIVE MISS. THE FIRST EYE DONE WAS LEFT EYE AND A ZXR WAS IMPLANTED. REPORTEDLY THE PATIENT SAW WELL BUT NOT AS MUCH NEAR AS WANTED. SO, FOR THE 2ND EYE (RIGHT EYE), THE SURGEON IMPLANTED A TECNIS 1 MULTIFOCAL MODEL ZLB00 +23.5 DIOPTER ON (B)(6) 2019 BECAUSE IT SHOWED A PREDICTED RX OF -0.16 WITH A LENS FACTOR OF 1.78 AND AN A-CONSTANT OF 118.8. THE PATIENT ENDED UP HYPEROPIC WITH A REFRACTION OF +0.75 +0.50 AT 145. SO, SE OF 1.0D. THE SURGEON NOW WANTS TO REPLACE THIS LENS ON (B)(6) 2019 WITH A SYMFONY. EXPLANT WAS SCHEDULED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8907224 ↗
• InjuryJul 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZLB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF POOR POST-OP REFRACTION. IT WAS REPORTED THE REPLACEMENT LENS WAS THE SAME MODEL BUT A HIGHER DIOPTER (24.5) IOL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8761913 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HALOS DAY AND NIGHT AT THE 2-3 WEEK FOLLOW-UPS AFTER THE IMPLANTATION OF THE LENS. LENS IMPLANTED IN PATIENT'S LEFT EYE (OS). AS A RESULT, LENS WAS EXPLANTED. THROUGH FOLLOW-UP, THERE WERE NO INCISION ENLARGEMENT AND NO VITRECTOMY, BUT THERE WERE SUTURES PERFORMED DURING SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8406303 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FOR THE PATIENT'S EYE DUE TO BLURRY VISION CAUSED BY UNADDRESSED CYLINDER. REPORTEDLY, THE CALCULATIONS WERE OFF. THE LENS WAS REPLACED WITH A MODEL ZCT225 25.0 DIOPTER LENS. THERE WAS NO PATIENT HARM AND NO OTHER SURGICAL INTERVENTION OTHER THAN THE EXCHANGE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8204064 ↗
• InjuryJun 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 23.5 DIOPTER LENS WAS IMPLANTED ON (B)(6) 2018 INTO THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A HYPEROPIC SURPRISE. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 24.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7577648 ↗
• InjurySep 1, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED AS INCORRECT POWER WAS SELECTED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT A DIFFERENT DIOPTER (24.5). IT WAS REPORTED THAT THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6840476 ↗
• MalfunctionAug 15, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT ONCE ADVANCED INSIDE THE CARTRIDGE, THE INTRAOCULAR LENS WAS TORN. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6795701 ↗
• 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 GLARES AND HALOS AFTER THE PROCEDURE AND COULD NOT DRIVE AT NIGHT. THE SURGERY CENTER PERFORMED A YAG PROCEDURE ON OU TO RESOLVE THE HALOS AND GLARES. 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 EXPLAINED TO THE

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

  MAUDE report 6757516 ↗
• InjuryJun 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO SEVERE HALOS AND GLARE. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Halo; No Code Available

  MAUDE report 6642280 ↗
• 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. THE GOAL WAS PLANO AND THE RESULT WAS PLANO +.13. THE PATIENT EXPERIENCED SEVERE GLARE, HALOS AND COULD NOT TOLERATE THE MULTIFOCAL LENS. THE LENS WAS REPLACED WITH A MONOFOCAL LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6438110 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZLB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT EXPERIENCING VISUAL DISTURBANCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6397591 ↗