TECNIS IOL ZKB00 (REF ZKB00U0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474560116), received between Aug 25, 2016 and Jul 21, 2022 — classified as 14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Adverse 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 BLURRY VISION. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 15080688 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZKB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2019. THE ZKB00 LENS WAS EXPLANTED ON (B)(6) 2019 TO IMPROVE VISUAL ACUITY AND REPLACED WITH A ZXT150 22.0 DIOPTER LENS. IT WAS REPORTED DURING THE EXPLANT PROCESS THE HAPTIC WAS PULLED OFF AND THERE WAS NO REQUIRED MEDICAL INTERVENTION. PATIENT OUTCOME WAS REPORTED AS NO PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9268335 ↗
• MalfunctionOct 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. THE EVENT WAS RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251751 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A ZKB00 INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT COMPLAINED OF HALOS, VISION WAS NOT CLEAR, AND FLICKERING. ADDITIONAL INFORMATION RECEIVED REVEALED THERE WERE NO COMPLICATIONS OR INJURIES DURING THE SURGERY. VISION HAS IMPROVED BUT THE FLICKERING PERSISTS. THE PATIENT ALSO REPORTED THAT HE MAY HAVE WRINKLING IN THE BACK OF THE EYE. THE PATIENT STATED THE SYMPTOMS AFFECT HIS DAILY ACTIVITIES SUCH AS DRIVING AT NIGHT. THE PATIENT STATED IN A SUBSEQUENT COMMUNICATION AFTER THE REFRACTIVE PERIOD THAT HE IS MISERABLE BECAUSE OF THE FLICKERING AND VIBRATIONS OF THE IOL.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9039960 ↗
• InjuryAug 6, 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 EXPLANTED DUE TO THE PATIENT EXPERIENCING DIPLOPIA VERTICALLY IN THE RIGHT EYE, TROUBLE FOCUSING, AND SEEING SMALL SHADOWS UNDER LETTERS WHEN READING. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO PATIENT INJURY POST-EXPLANT. FOLLOW-UP CONFIRMED THAT THE PRODUCT WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 8863161 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANT WAS PERFORMED FROM PATIENT LEFT EYE FOR THE SPECIFIC VISUAL ISSUES OF BLURRY VISION, HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES. THE PATIENT WAS DOING GOOD. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8580353 ↗
• InjuryNov 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ZKB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO PATIENT COMPLAINT OF SEEING THE RINGS OF THE MULTIFOCAL LENS; HE WANTED A CLEAR LENS WITHOUT THE RINGS. ZKB00 IOL WAS EXCHANGED AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING INCISION ENLARGEMENT. THERE WAS NO COMPLICATIONS SUCH AS CAPSULE TEAR, NO SERIOUS PATIENT INJURY, NO SUTURE(S), NO VITRECTOMY, AND PATIENT OUTCOME WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Disturbances

  MAUDE report 8031195 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. POST-OPERATIVELY, THE PATIENT COMPLAINS OF NOT CLEAR VISION/BLURRY VISION SINCE THE SURGERY, INCLUDING GLARE. THEREFORE, THERE IS A PLANNED EXPLANT TO BE PERFORMED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7546979 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.5 DIOPTER LENS WAS IMPLANTED IN A PATIENT'S RIGHT EYE ON (B)(6) 2017. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO HYPEROPIA. THE REPLACEMENT LENS WAS OF THE SAME MODEL, BUT NOTED TO BE A DIFFERENT DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO CAPSULE TEAR AND NO VITRECTOMY REPORTED. THE PATIENT OUTCOME AT THE TIME OF DISCHARGE WAS REPORTED AS BEING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7528074 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VITRECTOMY WAS PERFORMED ON THE PATIENT AND THE ZKB00 21.5 DIOPTER LENS WAS CUT OUT OF THE BAG. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 7378471 ↗
• InjuryOct 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2016. REPORTEDLY, THE PATIENT EXPERIENCED SEVERE GLARE AND HALOS. THE PATIENT''S VISUAL ACUITY WAS 20/20 AND J1+. THE DOCTOR RECOMMENDED A YTTRIUM-ALUMINUM GARNET (YAG) CAPSULOTOMY PROCEDURE IN BOTH EYES, BUT EXPLAINED THAT IF IT WERE PERFORMED, A LENS EXCHANGE WOULD NOT BE POSSIBLE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT''S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6967601 ↗
• MalfunctionJan 13, 2017Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S EYE, BUT THE LENS WOULD NOT UNFOLDED DUE TO A BAD INJECTOR/CARTRIDGE. THE LENS WAS REMOVED FROM THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6250999 ↗
• InjuryOct 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2016, ON THE RIGHT EYE OF A MALE PATIENT. THE PATIENT HAS MANY ISSUES WITH THE FOCUS POINT SINCE THE SURGERY. HE IS UNABLE TO READ AND EVERYTHING IS BLURRY. PATIENT IS REQUESTING GUIDANCE TO SEE IF THIS IS NORMAL AND HOW LONG IT WILL TAKE BEFORE THE ISSUES DISAPPEARS. HE HAS SEEN HIS PHYSICIAN AND HE WAS TOLD THAT HIS EYE HAS NO ISSUES. PER THE PATIENT, HIS PHYSICIAN HAS DONE A WONDERFUL JOB ON THE IMPLANT, BUT PATIENT IS JUST UNABLE TO SEE. THE PATIENT'S LAST DOCTORS VISIT WAS ON (B)(6). DURING THAT TIME, THE DOCTOR CONTINUED TO PRESCRIBE AND TREAT THE PATIENT WITH DUREZOL. THE PATIENT HAS A FOLLOW UP VISIT SCHEDULED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 6012416 ↗
• InjuryOct 5, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS GOING TO BE EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO THE PATIENT CONSISTENTLY SEEING BLUE COLOR. EXPLANT OF THE LENS WAS LATER CONFIRMED. AT EXPLANT THERE WAS NO POST OP COMPLICATIONS. THERE NO INCISION ENLARGEMENT AND NO SUTURE REQUIRED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 5998970 ↗
• InjurySep 27, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO A MECHANICAL COMPLICATION OF THE IOL, DETAIL OF MECHANICAL COMPLICATION WAS NOT PROVIDED. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THE ZKB00 IOL WAS REPLACED WITH A NON-AMO LENS.

  Patient problems: No Code Available

  MAUDE report 5978976 ↗
• InjuryAug 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DR. PERFORMED AN INTRAOCULAR LENS EXCHANGE/EXPLANT AFTER DIAGNOSIS OF MYOPIA IN THE RIGHT EYE. THERE WAS NO INCISION ENLARGEMENT AND NO INJURY. NO SUTURES WERE USED AND ANOTHER LENS OF A DIFFERENT MODEL WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 5904693 ↗