TECNIS IOL ZKB00 (REF ZKB00U0190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474560062), received between Oct 19, 2016 and Nov 24, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS OF BOTH EYE WERE EXPLANTED AND REPLACED WITH A NEW NON J&J TORIC INTRAOCULAR LENS. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. THE PATIENT'S CONDITION IS STABLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE PATIENT'S RIGHT EYE EXPLANT. ANOTHER REPORT WILL CAPTURE PATIENT'S LEFT EYE.

  Patient problems: Eye Injury

  MAUDE report 20767318 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING SIGNIFICANT HALOS AND POOR CONTRAST SENSITIVITY. THE REPLACEMENT LENS IS A DIFFERENT MODEL BUT SAME DIOPTER, DCB00 19.0 DIOPTER. THERE WERE NO PATIENT INJURIES OR MEDICAL INTERVENTIONS SUCH AS CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. THE EXPLANTED IOL WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. POST-OPERATIVE, THE PATIENT IS REPORTED AS BETTER VISUAL SYMPTOMS. REPORTEDLY, THE CUSTOMER CANNOT PROVIDE ANY FURTHER INFORMATION THEREFORE NO FOLLOW-UP IS NEEDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16457528 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS THE HAPTIC WAS BENT/ BROKEN. ANOTHER J&J LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951808 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE, AND WAS REPLACED WITH A LOWER DIOPTER NON-JOHNSON & JOHNSON SURGICAL VISION IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 13380130 ↗
• InjuryApr 12, 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 MECHANICAL COMPLICATIONS DESCRIBED AS BLURRED VISION NEAR AND DISTANCE. IT WAS ALSO NOTED THAT THERE WERE HALOS AROUND LIGHTS. VISUAL ACUITY PRE-OP 20/30, POST-OP 20/40. THERE WAS NO PATIENT POST-OP INJURY. REPLACEMENT IOL WAS A MODEL ZKB00 20.0 DIOPTER IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 9951873 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS REMOVED DUE TO DYSPHOTOPSIA. IT WAS REPLACED WITH A ZCB00 IOL. THERE WAS NO INCISION ENLARGEMENT. THE PATIENT IS DOING FINE, NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8926684 ↗
• InjuryJun 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 THE PATIENT'S LEFT EYE DUE TO PATIENT COMPLAINT OF HAZING OR GLARE AND HALOS. THE LENS WAS REPLACED WITH A NON J&J LENS. PATIENT WAS REPORTED AS HAPPY AND DOING WELL POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8697706 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00, 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT RIGHT EYE. POST-OPERATIVELY, THE RESULTS WERE NOT AS INTENDED. THE PATIENT COMPLAINED OF BLURRED VISION AND COULD NOT READ. THERE WERE NO INJURIES AND NO ADDITIONAL INTERVENTION WAS PERFORMED. AT THE 1-MONTH POST-OP VISIT, THE PATIENT WAS 20/40-1 UNCORRECTED VISUAL ACUITY (UCVA); +1.00+0.25X35 MANIFEST REFRACTION, +0.75+0.50X39 AUTO REFRACTION. UNCORRECTED VISION NEAR (UCVN) WAS J10 @ 16 INCHES. BEST CORRECTED FINAL VISUAL ACUITY (VA) WAS 20/25; FINAL NEAR VA WAS J1-1 @ 16 INCHES, DISTANCE 20/25. IT WAS REPORTED THERE WAS NO MALFUNCTION WITH THE IOL. THE SURGEON THEN PERFORMED AN IOL EXCHANGE TO A ZKB00, 21.0 DIOPTER SIZE. NO REPORT OF INCISION ENLARGEMENT, VITRECTOMY AND SUTURES DONE. NO PATIENT POST-OP INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8630149 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING FUZZY AND AN OVERALL UN-HAPPINESS WITH THE NEAR VISION FOLLOWING THE IMPLANTATION OF A MODEL ZKB00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS). AS A RESULT, LENS HAD TO BE EXPLANTED. THE INCISION WAS ENLARGED TO 3.0MM FOR THE EXPLANT. THE LENS WAS REPLACED WITH A TECNIS TORIC SYMFONY LENS, AN INCREASE OF 0.5 DIOPTERS STRONGER, PLUS THE TORIC COMPONENT. THERE WAS UNACCOUNTED ASTIGMATISM, PROBABLY FROM THE POSTERIOR CORNEA, NOT NOTED FROM THE ANTERIOR SURFACE. PATIENTS VISION IMPROVED POST OP DAY ONE VISIT. ONE DAY POST-OP SHOWED IMPROVED ACUITY OF 20/30; HOWEVER, IT WAS TOO EARLY TO DETERMINE FINAL VISUAL OUTCOME. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8203957 ↗
• InjuryAug 24, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZKB00 19.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE LENS BECAME DECENTERED POST-OPERATIVELY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED FOR THE EXPLANT. THE REPLACEMENT LENS WAS A ZMA00 18.5 DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7815190 ↗
• InjuryApr 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 19.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT WAS UNABLE TO GET USED TO THE MULTIFOCAL LENS AND FELT VISION WAS BLURRY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7449676 ↗
• InjuryJan 23, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +19.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF LENS DISLOCATION. MODEL ZMA00, A 3 PIECE MULTIFOCAL LENS WAS IMPLANTED AS A REPLACEMENT LENS FOR THE PATIENT. PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7213630 ↗
• InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO THE PATIENT EXPERIENCING BLURRY VISION. THE LENS WAS REPLACED WITH A MODEL ZLB00 20.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THERE WAS NO POST-OP PATIENT INJURY.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6039058 ↗