TECNIS IOL ZKB00 (REF ZKB00U0220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474560123), received between Oct 16, 2016 and Oct 31, 2025 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED, MULTIFOCAL INTRAOCULAR LENS WAS IMPLANTED IN A PATIENT WHO LATER EXPERIENCED HAZY, FOGGY, AND CLOUDY VISION IN HER RIGHT EYE. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS OF 21.5 DIOPTER. THE PATIENT'S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/30+2 AND BSCVA POST-OPERATIVE WAS 20/20+1. NO UNPLANNED COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, OCCURRED DURING THE SECONDARY SURGERY. THERE WERE NO DELAYS IN THE PROCEDURE, AND NO MEDICAL ATTENTION OR PRESCRIBED MEDICATIONS OUTSIDE OF STANDARD CARE WERE REPORTED. THE PATIENT HAS FULLY RECOVERED. THE DIRECTION FOR USE OF THE DEVICE WAS FOLLOWED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23441704 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INSERTION, THE ZKB00 MODEL INTRAOCULAR LENS (IOL) PERFORATED/PUNCTURED THE POSTERIOR CAPSULE. IT WAS CONFIRMED THE IOL WAS FULLY INSERTED IN THE PATIENT'S EYE. THE INCISION WAS ENLARGED AND AN ANTERIOR VITRECTOMY WAS PERFORMED HOWEVER, THERE WAS NO SERIOUS PATIENT INJURY AND NO SUTURES. THE PROCEDURE WAS COMPLETED USING A AR40E 20.5 DIOPTER IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS EXCELLENT. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 22287845 ↗
• InjuryJul 2, 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 LEFT EYE (OS) 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 PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 19662203 ↗
• InjuryJan 28, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THE LENS HAD A BROKEN HAPTIC DURING POST-OPERATIVE EXAMINATION AND THE LENS SHIFTED INSIDE THE EYE. ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO OTHER PATIENT INJURY AND NO INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13389410 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INTOLERANCE FROM THE TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) POST-IMPLANT IN HER LEFT (OS) EYE. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. REPORTEDLY, THE PATIENT IS DOING FINE POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11775063 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S LEFT (OS) EYE DUE TO HAVING BLURRY VISION AND WAS NOT SEEING WELL. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 11766667 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT AFTER A ZKB00 MODEL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED THEY NOTICED A TORN HAPTIC. THE EVENT WAS OBSERVED AFTER INSERTION OF LENS INTO PATIENT'S LEFT EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. PATIENT WAS DOING OKAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606773 ↗
• MalfunctionMar 31, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) BUT WAS EXPLANTED DUE TO LENS NOT COMPATIBLE WITH THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO PATIENT POST-OP INJURY, PATIENT DOING OK. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600103 ↗
• InjuryFeb 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO INCORRECT POWER IMPLANTED. THERE WAS NO SURGICAL/MEDICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL (21.5) DIOPTER WAS USED. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388289 ↗
• InjuryJul 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD AN INTRAOCULAR LENS (IOL) EXPLANTED FROM HIS OPERATIVE EYE DUE TO MECHANICAL COMPLICATION WITH IOL RESULTING IN BLURRED VISION WITH NEAR/DISTANCE. THE PRE-OP VISUAL ACUITY (VA) WAS 20/40, POST-OP 20/20, BUT THE PATIENT HAD POOR READING. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10348327 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZKB00 22.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR. THE PATIENT EXPERIENCED GLARE AND BLURRY VISION. THE EXPLANTED LENS WAS REPLACED WITH A LENS OF THE SAME MODEL BUT HIGHER DIOPTER (23.5). THE EXPLANTED LENS WAS DISCARDED AFTER EXPLANTATION. THERE WERE NO INJURIES OR INTERVENTION REQUIRED DURING THE EXPLANTATION PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8924258 ↗
• InjuryJun 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO SUBLUXATION CAUSING HALOS. IN FURTHER FOLLOW UP, IT WAS REPORTED THAT THE PATIENT WAS SEEN (B)(6) 2019; WHERE THE HALOS WERE FIRST NOTICED. DOCTOR HAD THE PATIENT RETURN TWO (2) WEEKS LATER TO SEE IF THERE WAS ANY IMPROVEMENT AND TO DETERMINE WHICH EYE HAD THE HALOS. PATIENT RETURNED ON (B)(6) 2019, AND STILL COMPLAINED OF HALOING IN THE LEFT EYE. PATIENT WAS UNHAPPY AND WANTED THE LENS EXCHANGED. THE LENS WAS REPLACED WITH A NON J&J LENS. THE PATIENT WAS REPORTED AS HAPPY AND DOING WELL POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8689457 ↗
• MalfunctionDec 30, 2018Break; Break

  IT WAS REPORTED A ZKB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) HAD TO BE REMOVED FROM THE PATIENT'S LEFT EYE BECAUSE THE HAPTIC WAS RIPPED UPON INSERTION. THERE WAS NO SURGICAL INTERVENTION REQUIRED. THROUGH FOLLOW UP IT WAS REPORTED, THE PATIENT'S EYE AFFECTED AREA FEELS IMPROVEMENT AND IS DOING WELL. THE PATIENT'S VISION IS BLURRY, AND IMPROVED. THE PATIENT EXPERIENCES NO DIPLOPIA. THE CONDITION'S SEVERITY IS NONE. CUSTOMER ALSO INDICATED THAT THE LENS WAS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8205392 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +22.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE THE PATIENT WAS UNABLE TO ADAPT TO THE MULTIFOCAL LENS. REPORTEDLY, THE PATIENT WAS EXPERIENCING HALOS SINCE THE SURGERY AND HE HAS ALSO NOTICED "GHOSTING" IMAGES WHILE PLAYING TENNIS. THERE WAS NO PATIENT INJURY, NO COMPLICATIONS DURING THE EXPLANT PROCEDURE. A LENS FROM ANOTHER MANUFACTURER WAS USED AS A REPLACEMENT FOR THE PATIENT. PATIENT WAS REPORTED AS STABLE WHEN DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7637279 ↗
• InjuryOct 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) 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 RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6967602 ↗
• InjuryMay 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED HER VISION IS OKAY, NOT WHAT SHE EXPECTED, AND IT FEELS AS THOUGH THERE IS A FILM OVER HER EYES, ESPECIALLY THE LEFT EYE. THE PATIENT UNDERWENT AN YTTRIUM ALUMINIUM GARNET (YAG) PROCEDURE FOR THE LEFT EYE AND NOT THE RIGHT EYE. HER PHYSICIAN TOLD HER THAT SHE STILL HAS A SLIGHT ASTIGMATISM. THE PATIENT IS FRUSTRATED AS HER VISION HAS DECLINED AND FLUCTUATES MOSTLY ON THE LESS THAN ACCEPTABLE OF 20/40. ADDITIONALLY, SHE REPORTED NOT FEELING BALANCED WHICH AFFECTS STANDING AND WALKING, VARIOUS LIGHTS AFFECT MY VISION AND I HAVE TO KEEP LOW LIGHTING ON. DAMPNESS SEEMS TO AFFECT MY EYES. I SEEM TO BE ABLE TO USE MY COMPUTER AND READ OKAY. TRYING TO READ DIGITAL NUMBERS SUCH AS THOSE ON A TV OR RADIO IS NOT CLEAR AND ADJUSTING TO READ THEM IS DIFFICULT. I HAVE ALSO HAD RECENT OCULAR MIGRAINES. I HAVE VISITED TWO RETINA SPECIALISTS WHO DID SEE THAT THE GEL HAS NOT SETTLED IN MY EYES. I AM TRYING TO FIND OUT WHAT PART THE GEL PLAYS, AND/IF THERE IS ANOTHER REASON FOR MY MOST TROUBLESOME LEFT EYE. THIS REPORT WILL CAPTURE THE ZKB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) IMPLANTED IN THE LEFT EYE AND A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE. NO FURTHER INFORMATION W

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6574212 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE, DUE TO DYSPHOTOPIA, HALOS AND GLARE. THE LENS WAS REPLACED WITH A MONOFOCAL LENS, A MODEL ZCB00 LENS AND THE PATIENT WAS REPORTED AS FINE POST OP. THERE WAS NO PATIENT POST OP INJURY REPORTED.

  Patient problems: Halo; No Code Available

  MAUDE report 6434398 ↗
• InjuryDec 9, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THERE WAS LENS VAULT OF A ZKB00 22.0 DIOPTER INTRAOCULAR LENS AND THE LENS WAS EXCHANGED. FURTHER INFORMATION WAS PROVIDED AND IT WAS LEARNED THE PATIENT IS A FEMALE AND THE AFFECTED EYE IS THE LEFT EYE. ALSO NOTED IS THE PATIENT EXPERIENCED DOUBLE VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES, NO PATIENT COMPLICATION AND NO PATIENT INJURY POST-OP. THE REPLACEMENT LENS WAS ANOTHER ZKB00 OF A HIGHER DIOPTER (23.0).

  Patient problems: No Code Available

  MAUDE report 6157153 ↗
• InjuryOct 16, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A MODEL ZKB00 INTRAOCULAR LENS (IOL) 22.0 DIOPTER WAS EXPLANTED FROM A MALE PATIENT'S LEFT (OS) EYE DUE TO MECHANICAL COMPLICATION (DETAIL NOT PROVIDED) AND POOR VISUAL RESULT. THE INCISION WAS ENLARGED AND SUTURES WERE USED. ANOTHER LENS OF A DIFFERENT MODEL WAS USED AS THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6032872 ↗