TECNIS IOL ZKB00 (REF ZKB00U0230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474560147), received between Sep 23, 2016 and Dec 8, 2020 — classified as 8 injuries, 3 malfunctions.

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

• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PLANNED TO BE EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A MECHANICAL ISSUES. FURTHER INFORMATION WAS PROVIDED AND IT WAS LEARNED THAT THE LENS WAS EXPLANTED DUE TO A PROGRESSION LOSS OF VISION, DUE TO DYSPHOTOPSIA. EVENT WAS INTERFERING WITH DAILY ACTIVITIES. THE LENS WAS DISCARDED AFTER BEING EXPLANTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT IS DOING GREAT AFTER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10969158 ↗
• InjuryDec 9, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED IN THE PATIENT'S RIGHT EYE DURING THE SAME-DAY PROCEDURE; POSSIBLY DUE TO THE LENS BEING OFF CENTERED. A VITRECTOMY WAS REQUIRED, HOWEVER, THERE WAS NO OTHER PATIENT INJURY REPORTED. THE PATIENT IS DOING FINE AND IS SCHEDULED TO IMPLANT A DIFFERENT MODEL OF LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vitrectomy

  MAUDE report 9438216 ↗
• InjuryJun 21, 2019Adverse 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 +23.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE THE PATIENT WAS EXPERIENCING GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. REPORTEDLY, LENS MODEL ZCT150 +23.0 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS FINE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8725274 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +23.0 DIOPTER) WAS IMPLANTED. AFTER WHICH IT WAS REPORTED THAT PATIENT HAD SEVERE DISTORTION, FLICKERING, 10 TIMES WORSE THAN BEFORE SURGERY, NIGHT DISTORTION, HALOS, LIGHTS CONJOINING, SUNBURSTS- TWICE AS BAD AS BEFORE. REPORTEDLY ON LOWER RIGHT SIDE OF HER VISION IT LOOKS LIKE A BLACK LINE, FEELS LIKE SOMETHING IS IN PATIENT¿S EYE THAT SHOULDN'T BE THERE, FEELS LIKE PATIENT IS WEARING SOMEONE ELSE'S GLASSES ON, FEELING CROSS EYED. FLICKERING MOVEMENT IS CONTINUOUS, EVEN IF PATIENT IS NOT MOVING HER EYE. PATIENT WAS CONCERNED IF THE WRONG LENS WAS INSERTED OR WRONG LENS WAS IN THE PACKAGE OR WERE THE MACHINES NOT CALIBRATED CORRECTLY. EVERYTHING FEELS WORSE THAN DAY 1 POST OP. PATIENT WAS WORKING WITH THE SURGEON TO DISCUSS ABOUT POSSIBLE EXPLANT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body Sensation in Eye; Halo; Visual Disturbances

  MAUDE report 8167308 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 23.0 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OD (RIGHT EYE). POST IMPLANT THE PATIENT HAD HYPEROPIC RESULTS. THE DATE OF SURGERY WAS (B)(6) 2018. IOL MASTER INDICATED THAT A CONSTANT USED WAS CORRECT: 119.3 SRKT. THE PATIENT RECEIVED A +1.0D PIGGYBACK AR40 LENS TO CORRECT THE MISS IN A SEPARATE PROCEDURE. THE PATIENT IS OKAY POST-OP. THERE WAS NO WOUND ENLARGEMENT AND NO VITRECOMY THAT OCCURRED. THE SUSPECT ZKB00 LENS REMAINS IN THE PATIENT¿S EYE.

  Patient problems: No Code Available

  MAUDE report 8140381 ↗
• MalfunctionNov 7, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED WHEN REMOVING ZKB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) FROM PACKAGING CUSTOMER ACCOUNT REPORTED THE STERILE PACKAGING WAS NOT IN THE BOX; THE LENS AND CONTAINER WERE IN THERE BUT NOT STERILE. THERE IS NO PATIENT CONTACT, NO SERIOUS PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH SAME MODEL AND DIOPTER SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8048328 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT SHE HAD THE CATARACT SURGERY AND WAS IMPLANTED WITH THE TECNIS MULTIFOCAL INTRAOCULAR LENSES IN BOTH EYES (OU). THE PATIENT COMPLAINED OF HAVING VISUAL DISTURBANCE AND IMPAIRED VISION THAT REQUIRES BI-FOCAL GLASSES. THE ISSUE OF HAZING AND WORSE VISION WAS REPORTED IMMEDIATELY AND SHE WAS TOLD THAT SHE COULD WEAR READING GLASSES UNTIL AN ADDITIONAL EASY FIX WAS MADE WITH THE ADDITION OF LASER SURGERY. THE RIGHT EYE IMPLANT WAS PERFORMED ON (B)(6) 2017, THE SECOND EYE WAS IMPLANTED TWO WEEKS LATER. THE IMPLANTS ARE STILL IN PLACE. THE PATIENT REPORTED THAT AFTER RECEIVING HER LENSES, SHE COULD NOT DRIVE ANY FURTHER THAN ONE MILE WITHOUT FEAR OF EXPERIENCING AN UNCONTROLLABLE IMPULSE TO SHUT HER EYES. ADDITIONALLY, SHE REPORTED ANY BRIGHT LIGHT, SUNSHINE OR EVEN HOME LIGHTING OR ANY ATMOSPHERIC CHANGE WOULD BOTHER HER. SOME DAYS SHE KNEW SHE COULD NOT DRIVE, DEPENDED ON SOMEONE ELSE TO DRIVE HER, AND WORE DARK GLASSES PROVIDED BY THE SURGEON. THE PATIENT WAS ADVISED TO USE EYE LID SCRUBS, REFRESH DROPS AND WAS GIVEN A PRESCRIPTION OF RESTASIS, ALL OF WHICH REPORTEDLY DID NOT HELP HER. A LASER PROCEDURE WAS PERFORMED, PATIENT REPORTEDLY STILL EXPERIENCING VARIO

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

  MAUDE report 7706119 ↗
• MalfunctionJul 20, 2017Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S EYE AND IT WAS REMOVED, DURING THE SAME SURGICAL PROCEDURE, BECAUSE IT WAS NOTICED CRACKED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6728837 ↗
• InjuryApr 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT FELT NAUSEOUS AFTER IMPLANTATION, HAVING SOME SORT OF IMBALANCE, AND COULD NOT TOLERATE THE IOL. THE DOCTOR DOESN'T ATTRIBUTE THE PATIENT'S SYMPTOMS TO THE PRODUCT. THE PATIENT HAD THE IOL EXCHANGED WITH A MONOFOCAL, MODEL ZCB00 LENS AND FEELS AND SEES A LOT BETTER NOW. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Nausea; No Code Available

  MAUDE report 6524845 ↗
• MalfunctionDec 8, 2016Material Puncture/Hole; Device Damaged by Another Device; Material Puncture/Hole; Device Damaged by Another Device

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PUNCTURED BY THE INSERTER DURING INSERTION INTO THE EYE. INFORMATION FOR THE INSERTER OR CARTRIDGE WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6155675 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED POOR NEAR VISION AND THERE IS A PLAN TO EXPLANT THE ZKB00, MULTIFOCAL INTRAOCULAR LENS AND REPLACE IT WITH A ZMB00, MONOFOCAL LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 5975261 ↗