TECNIS IOL ZKB00 (REF ZKB00U0225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474560130), received between Aug 26, 2016 and Jul 3, 2024 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FORM THE PATIENT'S RIGHT EYE (OD) DUE TO BLURRY VISION. IT WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL, NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES DONE. PATIENT DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 19672195 ↗
• InjuryMay 20, 2024Break; Break

  IT WAS REPORTED THE ZKB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF LENS MALFUNCTION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-J&J IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT STATUS POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356050 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO BLURRED VISION. THERE WAS NO PATIENT INJURY AND NO OTHER COMPLICATIONS LIKE INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE ORIGINAL LENS WAS REPLACED WITH DIFFERENT MODEL AND DIOPTER NON-JNJ LENS. PATIENTS OUTCOME WAS FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18247299 ↗
• InjuryMay 27, 2021Adverse 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 RIGHT EYE OF A PATIENT DUE TO POST-OPERATIONAL BLURRY VISUAL ACUITY. THE PATIENT'S SYMPTOMS FIRST NOTICED 2-DAYS POST-OP. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (24.0 D) WAS USED. IT WAS REPORTED THAT SUTURE WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT THE PATIENT'S VISUAL ACUITY WAS NOT CHECKED AT DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11891762 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). IOL WAS EXPLANTED DUE TO COMPLAINTS OF BLURRY VISION AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT OUTCOME POST-OPERATIVE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 11813434 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT AFTER THE IMPLANTATION OF A ZKB00 TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL), HE HAS BEEN HAVING SHARP SEARING EYE PAIN BEHIND HIS LEFT (OS) EYE AND IS SEEING HALOS AT NIGHT. THE DOCTOR COULDN¿T FIND ANYTHING WRONG. AFTER 4-5 MONTHS POST-SURGERY, THE DOCTOR DID A SCRAPE REGARDING HIS ASTIGMATISM. THE PATIENT WENT TO ANOTHER DOCTOR FOR A SECOND OPINION, BUT THE DOCTOR COULD NOT SEE ANYTHING WRONG AND THE PATIENT WAS PRESCRIBED EYE DROPS: MAXIFLOAXINE, DUREZOL, LOTEMAX, AND PROLENSA. IT IS STATED THAT THE PATIENT HAS SEEN HALOS FOR THE PAST THREE YEARS, AND THE EYE PAIN IMPAIRS HIM FROM PERFORMING NORMAL DAILY ACTIVITIES. THROUGH FOLLOW UP, IT WAS LEARNED THAT PATIENT HAD RECEIVED THE SAME LENS MODEL/DIOPTER IMPLANTED IN HIS RIGHT (OD) EYE. HOWEVER, HIS VISUAL SYMPTOMS ARE IDENTIFIED WITH HIS LEFT (OS) EYE. HE CONTINUES TO EXPERIENCE SPIDER WEB IN IN HIS VISION AND LOSS OF VISUAL ACUITY. THE SECOND SURGEON WHO HE SPOKE WITH DID NOT RECOMMEND TO REMOVE THE LENS AT THIS TIME, BECAUSE HIS BAG WOULD NOT HOLD THE LENS. HE IS CURRENTLY WEARING PRESCRIPTIVE GLASSES (CLAREL SQUARE GLASSES). BOTH LENSES REMAIN IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Pain; Visual Disturbances

  MAUDE report 10446707 ↗
• InjuryAug 29, 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 DUE TO PATIENT COMPLAINT OF DECREASED NEAR VISION AT POST OP APPOINTMENT. THE LENS WAS REPLACED WITH A MODEL ZKB00, 21 DIOPTER. THERE WAS NO ADDITIONAL INJURY OR INFORMATION REPORTED.

  Patient problems: No Code Available

  MAUDE report 8944049 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZKB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO PATIENT NOT BEING HAPPY WITH HIS VISUAL ACUITY AFTER SURGERY. THE IOL HAD PITS FROM THE YTTRIUM ALUMINUM GARNET (YAG) LASER PROCEDURE. THE PATIENT ALSO HAD RETINA SURGERY AFTER THE INITIAL CATARACT SURGERY AND HAS SILICONE OIL PLACED IN THE EYE. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT. THE REPLACEMENT LENS WAS A JOHNSON & JOHNSON SURGICAL VISION, MODEL ZA9003 22.5 DIOPTER LENS, VITRECTOMY WAS PERFORMED. THE PATIENT¿S VISUAL ACUITY HAS IMPROVED WITH AN UNCORRECTED VISION OF 20/50+2. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Impairment; Vitrectomy

  MAUDE report 8601126 ↗
• MalfunctionMar 13, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT A MARK WAS NOTICED ON THE LENS MODEL, ZKB00 MULTIFOCAL IOL (INTRAOCULAR LENS) AFTER IT WAS IMPLANTED IN PATIENT'S OPERATIVE EYE. FURTHER INFORMATION INDICATED THAT THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. IT WAS ALSO NOTED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE PATIENT WAS REPORTED DOING FINE POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8415790 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT AFTER BEING IMPLANTED WITH A ZKB00, 22.5 DIOPTER INTRAOCULAR LENS (IOL) DEVELOPED CLOUDY VISION, BECAUSE OF DRY EYE. THE DOCTOR ASCERTAINED THAT LENS WOULD NOT WORK. THE LENS WAS EXPLANTED REQUIRING INCISION ENLARGEMENT AND EXCHANGED FOR A PCB00 MONOFOCAL IOL. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 8355943 ↗
• InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +22.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE. REPORTEDLY INCISION ENLARGEMENT WAS PERFORMED DURING THE REMOVAL OF LENS. PATIENT WAS DOING FINE WITH NO COMPLICATIONS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7839144 ↗
• InjuryJan 4, 2018Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +22.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF GLARE. A NON-AMO INTRAOCULAR LENS OF THE SAME DIOPTER WAS IMPLANTED AS REPLACEMENT LENS FOR THE PATIENT. ADDITIONAL INFORMATION REPORTS THAT THE PATIENT COMPLAINED OF GLARE ABOUT 2 MONTHS AFTER INITIAL SURGERY OF (B)(6) 2016. NO PATIENT INJURY WAS REPORTED AND THE PATIENT WAS DOING GREAT WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7166192 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2017 DUE TO DYSPHOTOPSIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7073950 ↗
• InjuryOct 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO MECHANICAL FAILURE OF THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6967598 ↗
• InjuryApr 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOACULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2016. REPORTEDLY, THE PATIENT EXPERIENCED AN ARC IN HIS VISION. THE PATIENT WENT TO ANOTHER FACILITY AND HAD THE LENS EXPLANTED AND REPLACED WITH ANOTHER LENS. IT WAS REPORTED THAT THE PATIENT DID SEE THE IMPLANTING SURGEON FOR A ONE WEEK FOLLOW UP VISIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6509161 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT COMPLAINT THAT THEY COULD SEE "FOLD." THE PATIENT IS REPORTED AS FINE AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6262558 ↗
• InjuryJan 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO LENS POOR PERFORMANCE. PATIENT WAS DISSATISFIED WITH THE OUTCOME. THE LENS WAS REPLACED WITH A MONOFOCAL LENS WITHOUT INCIDENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO PATIENT POST-OP INJURY.

  Patient problems: No Code Available

  MAUDE report 6239945 ↗
• MalfunctionSep 15, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED A BLEMISH (PARTICLE OR SMUDGE) ON THE CENTER OF THE INTRAOCULAR LENS (IOL). THE BLEMISH WAS NOTICED DURING HANDLING OF THE IOL BUT PRIOR TO INSERTION. THE PHYSICIAN WAS NOT COMFORTABLE USING THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5955066 ↗
• InjuryAug 26, 2016Adverse 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 AS THE PATIENT WAS UNHAPPY WITH THE MULTIFOCAL LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5905703 ↗