TECNIS IOL ZKB00 (REF ZKB00U0205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474560093), received between Sep 20, 2016 and Feb 23, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZKB00, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. DURING THE POSTOPERATIVE EXAMINATION, THE PATIENT REPORTED BLURRY VISION, HALOS, AND GLARE. THE IOL WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. THE REPLACEMENT LENS INFORMATION IS UNKNOWN/NOT PROVIDED. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURING, PROCEDURAL DELAY, OR USE OF MEDICATIONS OUTSIDE STANDARD CARE WAS REQUIRED. THE PATIENT FULLY RECOVERED. BEST-CORRECTED VISUAL ACUITY IMPROVED FROM 20/30 PREOPERATIVELY TO 20/20+2 POSTOPERATIVELY. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 24421638 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A WEAK BAG WAS NOTED AFTER THE NON-PRE-LOADED ZKB00MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THE SUSPECT IOL WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED, REPLACEMENT IOL INFORMATION WAS NOT PROVIDED. SUTURES AND INCISION ENLARGEMENT WERE REQUIRED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FINE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20680125 ↗
• InjuryFeb 24, 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 EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO SEVERE DYSPHOTOPSIA. PATIENT HAD A GOOD POST-OPERATIVE (OP) VISIT AND DYSPHOTOPSIA WAS RESOLVED. THE CUSTOMER THINKS THAT SYMPTOMS DID SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES OF THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16440807 ↗
• InjuryFeb 23, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THE ZKB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF WRONG POWER IMPLANTED AND REPLACED WITH A ZKB00 20.0 DIOPTER IOL. THERE WAS NO MEDICAL AND NO SURGICAL INTERVENTION DURING THE SURGERY. PATIENT OUTCOME POST OP WAS REPORTED AS PATIENT HAPPY, 20/20- MR: -0.50 +0.50 X 155.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433173 ↗
• InjurySep 2, 2021Adverse 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 RIGHT EYE AS THE PATIENT HAD BLURRY VISION AND THE MULTIFOCAL LENS DID NOT WORK WELL FOR THE PATIENT. ANOTHER LENS OF DIFFERENT MODEL WAS PLACED AS THE REPLACEMENT. THERE WAS NO INJURY AND NO INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST-OPERATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12418822 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO PATIENT REPORTING OF SIGNIFICANT HALOS AND POOR CONTRAST SENSITIVITY. THERE WAS NO PATIENT INJURY. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL SAME DIOPTER LENS. PATIENT WAS VERY HAPPY WITH IMPLANTATION OF THE REPLACEMENT LENS. SUSPECT PRODUCT WAS DISPOSED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12349483 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 INTRAOCULAR LENSES (IOLS) WERE USED FOR THE RIGHT EYE ON THE SAME PATIENT. THE PHYSICIAN IMPLANTED THE ZKB00 LENS FIRST, BUT THE LENS SAC WOULD NOT HOLD, SO THE SURGEON REMOVED THE ZKB00 IOL. A VITRECTOMY WAS DONE. THEN THE SURGEON TRIED IMPLANTING THE ZMA00 LENS AND HAD THE SAME ISSUE. THE ZMA00 IOL WAS ALSO REMOVED FROM THE RIGHT EYE. THE SURGERY WAS COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT OUTCOME WAS GOOD. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE COMPLAINT ON THE SUSPECT ZKB00 LENS. A SEPARATE REPORT IS SUBMITTED TO CAPTURE REPORT FOR SUSPECT ZMA00 LENS.

  Patient problems: Capsular Bag Tear

  MAUDE report 12256687 ↗
• InjurySep 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS HAVING SIGNIFICANT ISSUES WITH GLARE OR HALOS AT NIGHT AND BLURRED VISION NOT PLEASED WITH THE VISUAL OUTCOME. PATIENT REQUESTED FOR AN EXPLANT AS HE IS VERY UNHAPPY WITH HIS NEAR VISION OF GLARE OR HALOS, NOT SATISFIED WITH SIDE EFFECTS OF LENSES AND VISUAL OUTCOMES. HE WAS NOT EXPECTING VISION TO BE THIS BAD. REPLACEMENT SURGERY OR AN EXPLANT IS YET TO BE SCHEDULED. ADDITIONAL INFORMATION STATES PATIENT IS UNABLE TO READ WELL AND EXPERIENCED LOSS OF 2 OR MORE LINES NOT FOR DISTANCE BUT HIS NEAR IS POOR. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 10498054 ↗
• InjuryJul 20, 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 A MALE PATIENT'S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO BLURRY VISION. THERE WAS NO DELAY IN PROCEDURE REPORTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. IT WAS NOTED THAT THE PATIENT IS SATISFIED WITH HIS VISION. VISUAL ACUITY PRE-OP: 20/50. VISUAL ACUITY POST-OP: 20/25. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10299535 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS UNHAPPY WITH HER LENS IN HER LEFT EYE AS HER VISION IS FUZZY AND SHE CANNOT READ CLOSE UP OR SEE DISTANCE VISION BECAUSE OF THE BLURRINESS. THE LENS WAS IMPLANTED IN (B)(6) 2019, AROUND ONE WEEK POST-OPERATIVE THE PATIENT STARTED NOTICING THE IMPAIRED VISION, AND SHORTLY AFTER HER IMPLANT, THE SURGEON CONDUCTED A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE. THE PATIENT WAS STILL DISSATISFIED. THE PATIENT WAS THEN REFERRED TO A RETINA SPECIALIST AND LATER A CORNEA SPECIALIST. BOTH SPECIALIST'S TOLD THE PATIENT HER RETINA AND CORNEA WERE FINE. THE PATIENT IS NOT HAPPY SHE STILL HAS TO USE READERS OR GLASSES. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 10269001 ↗
• InjuryFeb 1, 2020Adverse 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 THE PATIENT COMPLAINT OF POOR VISION. THE IOL WAS EXCHANGED FOR AN IOL OF A DIFFERENT MODEL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO PATIENT INJURY AND NO INTERVENTION PERFORMED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9656504 ↗
• InjuryNov 30, 2018Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT THE HAPTIC BROKE OFF DURING INSERTION OF TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +20.5 DIOPTER). THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. REPORTEDLY AN INCISION ENLARGEMENT WAS PERFORMED DURING THE PROCEDURE, BUT NO SUTURES WERE USED AND NO VITRECTOMY WAS PERFORMED. THE PATIENT HAD SMALL AMOUNT OF EDEMA BUT DOING OK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 8119032 ↗
• MalfunctionApr 14, 2018Bent; Scratched Material; Bent; Scratched Material

  IT WAS REPORTED THAT UPON OPENING THE LENS CASE, THE INTRAOCULAR LENS WAS OBSERVED NOT BEING IN THE CORRECT PLACE. REPORTEDLY, THE LENS WAS BENT OR BADLY SCRATCHED. THE LENS WAS NOT USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7431539 ↗
• InjuryAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 20.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED. PATIENT WAS POST LASIK AND CORRECT POWER WAS DIFFICULT TO CALCULATE. THE WOUND WAS NOT ENLARGED AND PATIENT WAS UNAFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6768631 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO PATIENT NOT BEING TO TOLERATE HALOS AND GLARE. THE LENS WAS REPLACED WITH A Z9002 IOL WITH A LOWER DIOPTER SIZE (19.5). THE EXPLANTED LENS FROM THE LEFT IS NOTED AS NOT BEING RETURNED. THE PHYSICIAN ALSO STATED THAT THIS WAS THE SECOND EXPLANTATION FOR THIS PATIENT. THE LENS IN THE RIGHT EYE WAS ALSO EXPLANTED ON (B)(6) 2017. THIS REPORT WILL CAPTURE THE LENS EXPLANTED FROM THE PATIENT''S LEFT EYE AND A SEPARATE REPORT WILL BE FILED FOR THE LENS EXPLANTED FROM THE RIGHT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6648939 ↗
• InjuryJan 31, 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 FROM THE PATIENT'S LEFT EYE DUE AN INCORRECT LENS POWER WHERE THE PATIENT WAS COMPLAINING ABOUT POOR VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6288803 ↗
• InjurySep 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A ZKB00 LENS HAD TO BE EXPLANTED DUE TO A POST-OP REFRACTIVE SURPRISE ON A POST LASIK PATIENT. THE INCISION WAS ENLARGED TO 3.0. THERE WAS NO VITRECTOMY OR SUTURES DONE AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 5965304 ↗