TECNIS IOL ZKB00 (REF ZKB00U0200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474560086), received between Nov 17, 2016 and Dec 3, 2024 — classified as 17 injuries, 3 malfunctions.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE MONOFOCAL LENS WAS EXPLANTED FROM THE RIGHT EYE BECAUSE OF BLURRY VISION AND MOST LIKELY THE PATIENT'S INABILITY TO TOLERATE THE IMPLANTED LENS. THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS. POST-OPERATIVELY, THE PATIENT IS DOING WELL AND THE REPLACEMENT LENS HAS HELPED ADDRESS THE CONCERNS.

  Patient problems: Blurred Vision

  MAUDE report 20837408 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO BLURRY VISION. IT WAS REPLACED WITH NON J&J IOL. DURING THE PROCEDURE, THREE SUTURES WERE APPLIED. NO INJURIES OR ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 19988178 ↗
• MalfunctionFeb 17, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED FROM PATIENT'S RIGHT EYE AS IT WAS SCRATCHED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE OUTCOME DID NOT INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553222 ↗
• InjuryApr 6, 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 IN A SECONDARY SURGICAL PROCEDURE AS THE PATIENT WAS UNHAPPY WITH HIS VISION AND WAS HAVING A LOT OF VISUAL DISTURBANCES WITH THE LENS. IT WAS INDICATED THAT THE PATIENT IS 20/20 FOR DISTANCE, 20/25 FOR INTERMEDIATE. THE PATIENT COMPLAINED OF EXTREME FLUCTUATING VISION AND GLARE AND HIS SYMPTOMS DID NOT IMPROVE UNTIL THE IOL WAS EXPLANTED. THE PATIENT¿S SYMPTOMS FIRST NOTICED POST-OP WEEK ONE (1) AND THE PATIENT WAS NOT COMFORTABLE DRIVING OR USING THE COMPUTER. THE PATIENT HAS DRY EYES AND IS AGGRESSIVELY TREATING WITH TEARS, COMPRESSES AND XIIDRA. REPORTEDLY, THE PATIENT HAS BLUE EYES AND HIS PUPIL IS LARGER (ABOUT 4.5 - 5MM). THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. A REPLACEMENT OF DIFFERENT MODEL AND DIOPTER (20.5 D) WAS USED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT THE PATIENT IS MUCH HAPPIER WITH HIS VISION NOW. IT WAS INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN. THE PATIENT WILL BE GETTING A MONOFOCAL IOL IMPLANT IN OTHER EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11621662 ↗
• MalfunctionMar 18, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SURGEON WILL BE REMOVING THE INTRAOCULAR LENS (IOL) FROM THE PATIENT'S RIGHT EYE. IT WAS STATED THAT THE IOL WAS SCRATCHED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510641 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE, AND A ZLB00 20.0 WAS IMPLANTED IN THE RIGHT EYE. THE PATIENT WAS TOLD AT THE DOCTOR¿S OFFICE BEFORE THE SURGERIES THAT HE¿D HAVE THE EYESIGHT OF A 20-YEAR OLD. HOWEVER, AFTER SURGERY, PATIENT IS EXPERIENCING HALOS, BLURRED VISION AND STARBURSTS. HE¿S ALSO HAVING DIFFICULTY WHILE DRIVING AT NIGHT, AND SIGN POSTS LOOK TWICE THEIR ACTUAL SIZE. THE PATIENT IS NOT USING ANY EYE DROPS. THRU FOLLOW-UP THE PATIENT REPORTED HE HAD FLOATERS PRIOR TO THE IMPLANTS BUT NOW THE FLOATERS ARE WORSE. HE IS EXPERIENCING THE SAME SYMPTOMS IN BOTH EYES, BUT THE LEFT IS EYE WORSE. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR WILL CAPTURE INFORMATION FOR THE LEFT EYE IOL MODEL ZKB00.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 9849381 ↗
• InjuryJun 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE MODEL ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED/REMOVED DUE TO DISLOCATION. THE LENS WAS REPLACED WITH A MODEL ZMA00 18.5 DIOPTER LENS. THERE WAS NO OTHER SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8684509 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNEXPECTED POSTOP REFRACTION. THERE WAS NO INCISION ENLARGEMENT OR SUTURE REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT LENS, ZKB00 21.5 DIOPTER (HIGHER POWER). REPORTEDLY, PATIENT IS DOING FINE POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8660168 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00, 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO HALOS AND GLARE. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. AND THE PATIENT IS DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8445697 ↗
• InjuryJan 15, 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 IMPLANTED INTO THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. THE IOL WAS EXPLANTED ON (B)(6) 2018 DUE TO PATIENT COMPLAINT OF BLURRY VISION AND GLARE. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PATIENT IS DOING FINE POST-OPERATIVELY. ADDITIONAL INFORMATION RECEIVED REVEALED THE EXPLANTED LENS WAS EXCHANGED WITH ANOTHER LENS WITHOUT INCISION ENLARGEMENT AND NO VITRECTOMY. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8251536 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL ZKB00 +20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, THE PATIENT COMPLAINED OF DYSPHOTOPSIA ALMOST IMMEDIATELY. THE IOL WAS EXPLANTED ON (B)(6) 2018 AND A MONOFOCAL Z9002 +19.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED. THERE WERE NO COMPLICATIONS AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8045343 ↗
• InjuryMar 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00 +20.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +19.5 DIOPTER) WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. THE PATIENT WAS REPORTED TO BE DOING WELL AT DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7311281 ↗
• InjuryJun 9, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE RIGHT EYE OF A MALE PATIENT BECAUSE THE LENS WAS DECENTERED. NO INCISION ENLARGEMENT OR NEGATIVE CONSEQUENCES TO THE PATIENT WERE REPORTED. THE PATIENT WAS REPORTED DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6629037 ↗
• InjuryMay 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MALE PATIENT REPORTED BEING IMPLANTED WITH A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) IN EACH EYE. PATIENT REPORTS HE HAS EXPERIENCED BLURRINESS WHICH HAS NOT IMPROVED SINCE SHORTLY AFTER THE LENSES WERE IMPLANTED. WEEKS AND MONTHS HAD GONE BY THERE WAS NO CHANGE IN THE PATIENT'S VISION. THE PATIENT FEELS THAT THE MULTIFOCAL IOLS ARE NOT WORKING UP CLOSE, SHORT DISTANCE, OR FOR LONG DISTANCE DUE TO EXCESSIVE BLURRINESS. THE PATIENT'S SYMPTOMS WERE ALSO ACCOMPANIED BY SIGNIFICANT PHYSICAL INSTABILITY AND IN ADDITION HIS BRAIN FELT LIKE IT WAS FLOATING ALL DURING HIS WAKING HOURS, THUS THE INSTABILITY. THE PATIENT ALSO HAS GLAUCOMA IN HIS RIGHT EYE. HIS EYE DOCTOR/SURGEON REFERRED HIM TO TWO NEUROLOGISTS TO SEE IF THE INSTABILITY AND DIZZINESS HAD SOMETHING TO DO WITH THE BRAIN OTHER THAN THE CATARACT SURGERY AND THE NEW LENSES. NO CONNECTION WOULD BE FOUND. THERE WAS NO EVIDENCE OF ANY BRAIN PROBLEM. PATIENT IS ABLE TO DRIVE SAFELY AND READ WITH DRUG STORE READERS GOOD LIGHTING AND MAGNIFICATION. HIS REFRACTION IS APPROXIMATELY 20/30 OR 20/35 BUT HAS INSTABILITY AND DAILY PERSISTENT BLURRINESS. PATIENT ALSO INDICATED THAT HE HAS DRY EYES AND SPORADIC BLEPHARITIS WHICH HAS INCREASED

  Patient problems: Blurred Vision; Dizziness; Dry Eye(s)

  MAUDE report 6568179 ↗
• InjuryMay 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MALE PATIENT REPORTED BEING IMPLANTED WITH A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) IN EACH EYE. PATIENT REPORTS HE HAS EXPERIENCED BLURRINESS WHICH HAS NOT IMPROVED SINCE SHORTLY AFTER THE LENSES WERE IMPLANTED. WEEKS AND MONTHS HAD GONE BY THERE WAS NO CHANGE IN THE PATIENT'S VISION. THE PATIENT FEELS THAT THE MULTIFOCAL IOLS ARE NOT WORKING UP CLOSE, SHORT DISTANCE, OR FOR LONG DISTANCE DUE TO EXCESSIVE BLURRINESS. THE PATIENT'S SYMPTOMS WERE ALSO ACCOMPANIED BY SIGNIFICANT PHYSICAL INSTABILITY AND IN ADDITION HIS BRAIN FELT LIKE IT WAS FLOATING ALL DURING HIS WAKING HOURS, THUS THE INSTABILITY. THE PATIENT ALSO HAS GLAUCOMA IN HIS RIGHT EYE. HIS EYE DOCTOR/SURGEON REFERRED HIM TO TWO NEUROLOGISTS TO SEE IF THE INSTABILITY AND DIZZINESS HAD SOMETHING TO DO WITH THE BRAIN OTHER THAN THE CATARACT SURGERY AND THE NEW LENSES. NO CONNECTION WOULD BE FOUND. THERE WAS NO EVIDENCE OF ANY BRAIN PROBLEM. PATIENT IS ABLE TO DRIVE SAFELY AND READ WITH DRUG STORE READERS GOOD LIGHTING AND MAGNIFICATION. HIS REFRACTION IS APPROXIMATELY 20/30 OR 20/35 BUT HAS INSTABILITY AND DAILY PERSISTENT BLURRINESS. PATIENT ALSO INDICATED THAT HE HAS DRY EYES AND SPORADIC BLEPHARITIS WHICH HAS INCREASED

  Patient problems: Blurred Vision; Dizziness; Dry Eye(s)

  MAUDE report 6568175 ↗
• MalfunctionMay 12, 2017Torn Material; Torn Material

  IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) GOT STUCK COMING OUT OF INJECTOR ADDITIONAL INFORMATION REVEALED THAT THE ISSUE WAS IN FACT THAT THE IOL WAS IMPLANTED AND REMOVED BECAUSE IT WAS TORN. THE IOL WAS REMOVED DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY OR SECONDARY SURGICAL PROCEDURE REQUIRED. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6565185 ↗
• InjuryFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZKB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) ON A FEMALE PATIENT'S LEFT EYE; THE PATIENT CAN¿T SEE AT ANY DISTANCE, HAS SEVERE GLARE AND RESIDUAL CYLINDER. THE PATIENT'S LAST REFRACTION WAS DONE ON (B)(6) 2017 AND WAS -.75 +1.75 AT 45 DEGREES. BEST CORRECTED TO 20/30 AND J2. THE LENS REMAINS IMPLANTED; HOWEVER, THE PHYSICIAN NOTED THAT A POSSIBLE EXPLANT MAY BE DONE, BUT NOTHING HAS BEEN PLANNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6302615 ↗
• InjuryDec 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO VEHEMENT HAZY VISION, COLOR OBSCURATION, VISUAL DISTURBANCE AND UNEXPECTED POST-OP REFRACTION. IT WAS REPORTED THAT THE SURGERY OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF PATIENT'S DAILY LIFE. PATIENT HAS NOW RECOVERED AFTER THE IOL WAS EXCHANGED WITH A MONOFOCAL LENS.

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

  MAUDE report 6174273 ↗
• InjuryNov 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BILATERAL LENS EXCHANGE WAS REQUIRED. A ZKB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A PATIENT EXPERIENCING WAXY VISION AND GLARE IN THE RIGHT EYE. LENS WAS REPLACED WITH A ZXR00 IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE RIGHT EYE AND SEPARATE MDR WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6115324 ↗
• InjuryNov 17, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZKB00 20.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE RIGHT EYE OF A FEMALE PATIENT DUE TO AN UNEXPECTED POST UP REFRACTION. LENS WAS REPLACED WITH THE SAME MODEL LENS BUT WITH A 19.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO PATIENT INJURY POST-OP AND PATIENT IS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 6111705 ↗