TECNIS IOL ZKB00 (REF ZKB00U0210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474560109), received between Aug 23, 2016 and Feb 24, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE (OS) DUE TO PATIENT EXPERIENCING VISUAL ISSUES, INCLUDING BLURRED VISION, HALOS, AND GLARE. THE REPLACEMENT LENS IS ANOTHER JOHNSON AND JOHNSON, WITH SAME MODEL BUT DIFFERENT DIOPTER ( ZKB00 22.0). THERE WAS NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION PRESCRIBED OUTSIDE OF STANDARD OF CARE WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THE DIRECTIONS FOR USE WERE FOLLOWED. PRE-OPERATIVELY, THE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/40 AND 20/25 POST-OPERATIVELY. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW-UP, IT WAS NOTED THAT THE THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT, AND THE PATIENT DID NOT REPORT ANY LOSS OF ABILITY TO PERFORM DAILY ACTIVITIES. THE PATIENT EXPERIENCE A LOSS OF TWO OR MORE LINES OF BSCVA. THE PATIENT WAS NEITHER OVER NOR UNDER CORRECTED. PRE-OP REFRACTION WAS -0.75 +1.25 X5, POST-OP REFRACTION WAS +0.75 SPHERE, AND THE INTENDED TARGET REFRACTION WAS PLANO SPHERE. THE POST-EXCHANGE REFRACTION WAS +0.50 +0.50 X90 . THE PATIENT HAD NO PRE-EXISTING CONDITIONS AFFECTING THE

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 24433778 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THE PATIENT EXPERIENCES BLURRY MID-RANGE VISION AND LACKS LONG-DISTANCE VISION, ALTHOUGH THEY CAN STILL READ. THEY STATED THERE IS A LOSS OF PERIPHERAL VISION IN BOTH EYES, BUT IT IS NOT AS SEVERE AS IN THE RIGHT EYE. IN THE RIGHT EYE (VISION IS WORSE) WITH A COMPLETE LOSS OF PERIPHERAL VISION, BLURRY MID-RANGE VISION, AND NO LONG-DISTANCE VISION. ADDITIONALLY, THE PATIENT HAS NO NIGHT VISION FOR DRIVING AND EXPERIENCES STARBURSTS AND HALOS. THE PATIENT REPORTED LOSS OF DEPTH PERCEPTION WHILE DRIVING AT NIGHT AND BEING BLINDED BY LIGHT. A SECOND OPINION HAS BEEN SOUGHT. PATIENT HAD BOTH LENSES REMOVED ON (B)(6) 2024 DUE TO DYSPHOTOPSIA, BOTHERSOME LACK OF PERIPHERAL VISION, BLURRINESS AT NIGHT WITH THE FIRST SYMPTOMS APPEARING 6 MONTHS AGO. THE PATIENT CURRENT STATUS IS BLURRY BUT GETTING BETTER. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE RIGHT EYE. A REPORT FOR THE LEFT EYE WAS SENT UNDER 3012236936-2024-0002178.

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 20022196 ↗
• InjuryMar 18, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THE ZKB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF WRONG POWER AND REPLACED WITH A ZKB00 17.5 DIOPTER IOL. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT STATUS POST LENS-EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570273 ↗
• 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 RIGHT 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 15080691 ↗
• InjuryJun 6, 2022Adverse 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 FROM A PATIENT'S RIGHT EYE DUE TO "MECHANICAL COMPLICATIONS." THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. A COMPETITOR BRAND IOL WITH 20.0 DIOPTER WAS IMPLANTED AS THE REPLACEMENT. IT WAS INDICATED THAT IT IS UNKNOWN HOW THE PATIENT IS DOING POST-OPERATIVELY. THROUGH FOLLOW-UP, THE "MECHANICAL COMPLICATION" WAS FURTHER CLARIFIED THAT THE PATIENT WAS EXPERIENCING VISUAL DISTURBANCES AND NOTICED BLURRED VISION IN THE AFFECTED EYE. THE PATIENT STATED NOT BEING HAPPY WITH PROGRESS OF VISION. TH PATIENT'S NEAR VISION HAD IMPROVED BUT DISTANCE VISION HAD NOT AND THE PATIENT WAS UNABLE ABLE TO READ SIGNS. THE PATIENT CAME IN COMPLAINING OF FLICKERING AND FLASHES OF LIGHT THE DAY AFTER SURGERY, HOWEVER THE PATIENT DID NOT COMPLAIN ABOUT THE FLICKERING OR FLASHES IN ANY OTHER VISIT AFTER THAT. ON (B)(6) 2022, THE PATIENT¿S DISTANCE VISUAL ACUITY WAS 20/60 WITHOUT CORRECTION. THE IMPLANTED MULTIFOCAL IOL WAS EXPLANTED AND A STANDARD LENS WAS IMPLANTED AS A REPLACEMENT (COMPETITOR BRAND). THE PATIENT STILL HAS A LITTLE BIT OF CORRECTION. THE LAST REFRACTION WAS UNCORRECTED 20/40, COR

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14608480 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THEM EXPERIENCING BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT IOL WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11977422 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED AN INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE REASON FOR EXPLANT WAS NOT PROVIDED. REPORTEDLY THERE WAS NO VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT OUTCOME IS FINE. PER THE CUSTOMER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 11052776 ↗
• InjurySep 18, 2020Adverse 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 FROM THE PATIENT'S LEFT EYE. THERE WAS NO PATIENT INJURY NOR RECORD OF SURGICAL AND MEDICAL INTERVENTIONS PERFORMED. ADDITIONAL INFORMATION STATED THAT THE PATIENT IS DOING GREAT POSTOP. THERE WAS NO ISSUE WITH THE LENS. PROCEDURE WAS COMPLETED USING ANOTHER ZKB00 LENS 22.5D 8025011916. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10557580 ↗
• InjuryMar 13, 2020Adverse 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 FROM THE LEFT EYE DUE TO PATIENT SEEING HALOS. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL, BUT SAME DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. THE PATIENT WAS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9827887 ↗
• InjuryDec 11, 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/EXCHANGED FROM THE PATIENT'S RIGHT EYE DUE THE PATIENT EXPERIENCING HALOS, GLARE AND STARBURSTS. THERE WAS INCISION ENLARGEMENT WHEN THE LENS WAS EXPLANTED. THE IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT IS DOING WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9454873 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT RIGHT EYE DUE TO THE PATIENTS BEING UNABLE TO TOLERATE HALOS AND GLARE. THE EXPLANTED IOL WAS REPLACED WITH A ZA9003 IOL. FOLLOWING THE EXCHANGE, IT WAS REPORTED THE PATIENTS VISION IS STILL BLURRY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Halo; No Code Available

  MAUDE report 8955228 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZKB00 21.0 DIOPTER LENS WAS EXPLANTED BECAUSE THE PATIENT WAS EXPERIENCING GLARE DURING THE DAY IN THE RIGHT EYE. AT EXPLANT A VITRECTOMY WAS REQUIRED. THE REPLACEMENT LENS IS A MODEL ZA9003 21.0 DIOPTER. REPORTEDLY THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8829632 ↗
• InjuryMay 20, 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 AS THE PATIENT COULD NOT TOLERATE THE MULTIFOCAL LENS. THE LENS WAS REPLACED WITH A NON JOHNSON & JOHNSON LENS, A 20.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THE PATIENT WAS REPORTEDLY DOING FINE POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8625364 ↗
• InjuryMar 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE ZKB00 MULTIFOCAL IOL (INTRAOCULAR LENS) THE PATIENT EXPERIENCED BLURRY VISION. REPORTEDLY A MILD SUBLUXATION NASALLY OF THE IMPLANTED LENS WAS NOTICED. AS A RESULT, THE LENS WAS PLANNED TO BE EXPLANTED ON (B)(6) 2019. PATIENT'S VISUAL ACUITY PRE-OPERATIVE: 20/40; PATIENT'S VISUAL ACUITY POST-OPERATIVE: 20/60. NO ADDITIONAL INFORMATION WAS PROVED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 8411719 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT EXPERIENCED HALO AND GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8368902 ↗
• InjuryDec 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00 21.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING INDICATED AS ONLY SPECIFIC VISUAL ISSUES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. LENS WITH SAME MODEL AND LARGER DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT HAD NO PROBLEMS POST-OPERATIVE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8192742 ↗
• InjuryJun 13, 2018Unintended Movement; Unintended Movement

  A REPORT WAS RECEIVED THAT A PATIENT CAME IN THE SURGERY CENTER ON (B)(6) 2018 DUE TO EXPERIENCING HALOS WHILE DRIVING AT NIGHT AND BLURRED VISION IN THE RIGHT EYE (OD) POST IMPLANT OF A MODEL ZKB00 INTRAOCULAR LENS (IOL). PER THE ACCOUNT, THE DOCTOR EXAMINED THE PATIENT'S OD AND DEEMED THAT THE IOL WAS SUBLUXED WITH REFRACTIVE SHIFT AND INTOLERABLE PHOTOPSIA. CONSEQUENTLY, THE DOCTOR RECOMMENDED THE IOL BE EXCHANGED. THE LENS WAS EXPLANTED ON (B)(6) 2018. IT WAS NOTED THAT THERE WERE NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURE REQUIRED AND THERE WAS NO INJURY POST-SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 7595108 ↗
• InjuryMay 4, 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 21. DIOPTER) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. POST-OPERATIVELY, THE PATIENT WAS UNHAPPY WITH THE LENS AND EXPERIENCING HALOS AND GLARE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE ZKB00 21.0 DIOPTER LENS IMPLANTED IN ONE OF THE PATIENT'S EYE. A SEPARATE REPORT WILL BE FILED FOR THE MODEL ZLB00 21.5 DIOPTER LENS IMPLANTED IN THE PATIENT'S OTHER EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 7489123 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. IMMEDIATELY AFTER SURGERY, THE PATIENT EXPERIENCED SHADOWS AND BLURRED VISION THAT BECOMES WORSE IN BRIGHTER LIGHT, BUT IS ALSO EVIDENT IN LOW LIGHT. REPORTEDLY, THE DOCTOR RECOMMENDED THE PATIENT TO HAVE A YTTRIUM-ALUMINUM GARNET (YAG) PROCEDURE, WHICH SHE DID HAVE COMPLETED ON (B)(6) 2017, BUT IT DID NOT HELP. FURTHERMORE, THE PATIENT IS USING EYE DROPS BECAUSE THE DOCTOR THINKS THE PATIENT MAY HAVE DRY EYES. HOWEVER, THE PATIENT STATED THEY ARE NOT HELPING THE PROBLEM. 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: Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 7338460 ↗
• InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +21.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT'S ASTIGMATISM, RESIDUAL CYLINDER OVER A DIOPTER. PATIENT ALSO WANTED MORE NEAR VISION. A NON-AMO TORIC INTRAOCULAR LENS WAS IMPLANTED AS REPLACEMENT LENS FOR THE PATIENT. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS DOING WELL POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7214411 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7069729 ↗
• InjuryNov 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INTRAOCULAR LENSES (IOL) IMPLANTED IN BOTH EYES. SINCE THEN, THE PATIENT CAN¿T READ/SEE PRINT AND IS UNABLE TO DRIVE DUE TO GLARE. THE PATIENT IS SEEING RINGS ON THE IOLS. SHE SAID THAT HER SYMPTOMS SIGNIFICANTLY INTERFERE WITH HER DAILY ACTIVITIES. THE PATIENT STATED THAT THE DOCTOR PLANS TO REMOVE THE LEFT LENS AT A FUTURE DATE. FOLLOW UP WITH THE DOCTOR'S OFFICE REPORTED THEY ARE STILL REVIEWING AND SAID THAT THEY ARE STILL THINKING ABOUT GOING THROUGH EXPLANTING OS (LEFT LENS) OR NOT ANYMORE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: 2 MDR¿S WILL BE SUBMITTED, ONE FOR EACH EYE. THIS REPORT DOCUMENTS THE EVENTS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7026810 ↗
• InjuryDec 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS NOT ABLE TO SEE NEAR AND FAR SIGHTED AFTER IMPLANTATION OF A ZKB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) IN HIS LEFT EYE. THE PATIENT NOTED THE DOCTOR STATED THAT HE DEVELOPED SECONDARY CATARACTS AFTER THE CATARACTS WERE REMOVED THE PATIENT STILL HAD ISSUES WITH HIS VISION. THE PATIENT STATES THAT HE IS ABLE TO DRIVE BUT HAS A DIFFICULTY SEEING. HE VISITED ANOTHER DOCTOR FOR A SECOND OPINION AND THE DOCTOR PRESCRIBED THE PATIENT EYEGLASSES. THE GLASSES HELPED A LITTLE BIT. THE ZKB00 IMPLANTED ON THE LEFT EYE IS BEING CAPTURED IN THIS REPORT AND A SEPARATE MDR IS BEING FILED FOR THE ZMB00 IMPLANTED ON THE RIGHT EYE.

  Patient problems: No Code Available

  MAUDE report 6157139 ↗
• InjuryOct 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL), 21.0 DIOPTER WAS EXPLANTED IN THE RIGHT EYE (OD) OF A FEMALE PATIENT BECAUSE OF POOR VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6019301 ↗
• InjurySep 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. NO PATIENT INJURY REPORTED. THE REPLACEMENT LENS WAS ANOTHER ZKB00 BUT A LOWER DIOPTER (19.5). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5935081 ↗