TECNIS IOL ZKB00 (REF ZKB00U0240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474560161), received between Dec 14, 2016 and Jun 14, 2024 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT HAD POOR MULTIFOCAL TOLERANCE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. THE EXPLANTED LENS WAS REPLACED WITH A BAUSCH AND LOMB IOL. THE PATIENT OUTCOME WAS REPORTED AS ¿GOOD¿. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 19543027 ↗
• InjuryJun 8, 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 A PATIENT'S LEFT EYE. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (22.5 D) WAS USED. THERE WAS NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING FINE POST-OP AND NO PATIENT INJURY WAS REPORTED. IT WAS INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 11962981 ↗
• InjuryJan 9, 2021Break; Break

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS (IOL) WAS IMPLANTED WITH A NON-JNJ CARTRIDGE INTO THE PATIENT¿S RIGHT EYE, BUT WAS THEN REMOVED BECAUSE THE LENS OPTIC WAS CRACKED. THE LENS WAS REMOVED AND REPLACED WITH A NON-JNJ IOL DURING THE SAME PROCEDURE. THERE WAS SOME BLEEDING AND DIAMOX WAS USED. REPORTEDLY, THE PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 11143958 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO LACK OF DISTANCE VISUAL ACUITY AND NEAR VISUAL ACUITY FROM PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. NO PATIENT POST-EXPLANT INJURY OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10768832 ↗
• InjuryNov 1, 2019Break; Break

  IT WAS REPORTED THAT A ZKB00, 24.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE. WHILE INSERTING THE IOL INTO THE EYE, THE DOCTOR NOTICED IT WAS SCRATCHED. THE LENS WAS IMPLANTED AND LEFT IN THE EYE. DOCTOR PLANS ON EXPLANTING IT TUESDAY (B)(6) 2019. THE SCRATCH IS CAUSING THE PATIENT TO HAVE VISUAL DISTURBANCE, LIKE A BUG IN THEIR FIELD OF VISION. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9269609 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH TECNIS MULTIFOCAL INTRAOCULAR LENS IN BOTH THE EYES. REPORTEDLY PATIENT WAS DISSATISFIED WITH THE LENS AND AFTER MAKING MULTIPLE ATTEMPTS TO IMPROVE PATIENT¿S VISION, PATIENT REMAINS UNHAPPY. PATIENT IS REFUSING THE LENS EXPLANT. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S ONE EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR PATIENT¿S ANOTHER OPERATIVE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8975577 ↗
• InjuryJul 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WAS IMPLANTED WITH A ZKB00 LENS IN BOTH EYES. AFTER IMPLANTATION OF A ZKB00 24.0 DIOPTER INTRAOCULAR LENS (IOL) IN HER LEFT EYE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE ISSUES, HALOS/GLARE AND INTOLERANCE WITH HER ZKB00. THERE IS NO PLAN TO EXPLANT BECAUSE THE PATIENT DOES NOT WANT THE LENS EXPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT ONLY HAD ISSUES WITH THE LEFT LENS. PATIENT DID NOT EXPERIENCE ANY ISSUES WITH THE LENS THAT WAS IMPLANTED ON (B)(6) 2016 (RIGHT EYE). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6742801 ↗
• InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A PATIENT WHO IS A CARPET CLEANER REPORTED THAT HE COULD NOT SEE UNDER ULTRA VIOLENT (UV) LIGHTS WHEN DOING INSPECTION AS PART OF HIS JOB. THE SYMPTOMS BEGAN AFTER THE PATIENT HAD HIS SECOND LENS IMPLANT ON (B)(6) 2016. ACCORDING TO THE CLINIC, IT WAS RECOMMENDED THAT THE PATIENT SHOULD TRY TO USE A DIFFERENT UV BLACK LIGHT (SOMETHING THAT EXCEEDS 40 NANOMETER). WHEN THE PATIENT RETURNED FOR A FOLLOW UP IN (B)(6) 2017, THE PATIENT DID NOT MENTION ANYTHING ABOUT HIS UV BLACK LIGHT ISSUE. THE PATIENT WAS MEASURED AND OVERALL, HIS VISION WAS PERFECT. THE FOLLOW UP PROVIDED STATED THAT THERE WAS NO PLAN TO EXPLANT THE LENSES, ESPECIALLY SINCE THE LENSES HAD BEEN IMPLANTED FOR A WHILE NOW AND THAT THE PATIENT DID NOT REALLY HAVE A CONCERN DURING HIS LAST FOLLOW UP VISIT. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6615303 ↗
• MalfunctionMay 29, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) WHEN OPENING THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6596403 ↗
• InjuryMay 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER BILATERAL IMPLANTS OF MODEL ZKB00, 24.5 AND MODEL ZKB00 24.0 DIOPTER INTRAOCULAR LENSES (IOL), THE PATIENT HAD BEEN SEEING LIGHTS UPON LIGHTS. PATIENT IS UNABLE TO DRIVE AS THE LIGHTS LOOKS LIKE FIREWORKS WHEN DRIVING. PATIENT STATED THAT HER SYMPTOMS ACTUALLY APPEAR ONLY AT NIGHT TIME. DURING THE DAY HER VISION IS OK. BUT WHEN NIGHT TIME COMES, SHE'S HAVING THE SYMPTOMS OF LIGHTS UPON LIGHTS WHICH OCCURRED GRADUALLY. SHE'S NOT SURE OF WHEN EXACTLY THEY STARTED. THIS REPORT WILL CAPTURE THE ZKB00 24.0 DIOPTER (D) LENS IMPLANTED ON (B)(6) 2016, AND A SEPARATE REPORT WILL FILED FOR THE ZKB00 24.5 D LENS.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6539308 ↗
• InjuryDec 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZKB00 24.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO THE PATIENT NOT BEING ABLE TO ADJUST WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6174095 ↗