TECNIS IOL ZCB00 (REF ZCB0000130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474531574), received between Oct 26, 2017 and Sep 17, 2021 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE) AND THE HAPTIC BROKE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH A BACK-UP LENS OF THE SAME MODEL AND DIOPTER SIZE. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12486101 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN THE RIGHT EYE OF A PATIENT WHICH WAS IMPLANTED WITH AN INTRAOCULAR LENS. THE EVENT OCCURRED ONE DAY POST OPERATION. POST OPERATIONAL DROPS GIVEN TO THE PATIENT WERE OFLOXACIN, LOTEMAX & PROLENSA. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT REQUIRED ADDITIONAL STEROID USE AND HAS FULLY RECOVERED. THE LENS REMAINS IMPLANTED AND THE HEALON ENDOCOAT DUET PRODUCT IS NOT AVAILABLE FOR RETURN. THE SURGERY CENTER INDICATED THAT THEY HAVE ONGOING INVESTIGATION AND NO SOURCES HAVE BEEN FOUND AT THIS TIME. THE ACCOUNT NOTED THAT THE LAST CASE OF TASS AT THEIR CENTER WAS 12/8/2020. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR IS FOR THE SUSPECT INTRAOCULAR LENS, MODEL ZCB00. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HEALON ENDOCOAT DUET. .

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11206466 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A MODEL ZCB00 INTRAOCULAR LENS (IOL), PATIENT EXPERIENCED SYMPTOMS OF BLURRY VISION, MILKY VISION AND COLOR CHANGES, LIKE WHITE DOGS ARE PURPLE AND BLACK DOGS ARE DARK BLUE. WHEN SHE WAS FIRST IMPLANTED, SHE FELT LIKE THERE WAS BRIGHT LIGHT ALL THE TIME AND NEEDED TO USE YELLOW TINTED SUNGLASSES. WHEN THE SUN IS OUT NOW THE SHE FEELS LIKE SHE IS IN UV LIGHT (PURPLE). WHEN READING SHE FINDS THE TEXT PALE GRAY, LIKE SHE IS WEARING DIRTY GLASSES. THE SURGEON HAS TOLD HER THAT THERE IS A SLIGHT POSTERIOR CAPSULE OPACIFICATION (PCO) BUT NOT MUCH. THE PATIENT THINKS THERE IS SOMETHING WRONG WITH THE IMPLANT. ADDITIONAL INFORMATION STATES THE SURGEON COULD TELL US THAT THE PATIENT ALREADY HAS PROBLEMS WITH THE OPERATED EYE THAT HAS NOTHING TO DO WITH THE IMPLANT, THERE IS ALSO QUITE A LOT OF PCO THAT HE WILL NOT REMOVE YET IF HE NEEDS TO EXPLANT THE IOL. FURTHER INFORMATION PROVIDED, PATIENT HAS HAD GOOD VISUAL ACUITY (VA) 20/20 FROM THE DAY AFTER SURGERY BUT COMPLAINS OF POOR CONTRAST SENSITIVITY (WHICH HAS NOT BEEN CONFIRMED IN ADEQUATE TESTING), A CHANGED SENSE OF COLOR PERCEPTION WITH A DOMINANCE OF BLUE (COLOR TESTING THOUGH NORMAL). IN A SL

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

  MAUDE report 9550349 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE PATIENT EXPERIENCING VISUAL ISSUES, HAVING TROUBLE SEEING TRAFFIC SIGNS. THERE WAS NOTHING WRONG WITH THE IOL. THE LENS WAS REPLACED WITH THE SAME MODEL ZCB00 BUT A HIGHER DIOPTER (19.5). REPORTEDLY, THERE WERE NO COMPLICATIONS SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 9352659 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZCB00 INTRAOCULAR LENS (IOL) WAS OPENED AND NOT IMPLANTED. THERE WAS A VITRECTOMY PERFORMED DUE TO A CAPSULAR TEAR. THERE WERE NO SUTURES. REQUESTS FOR ADDITIONAL INFORMATION HAVE NOT BEEN RETURNED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Capsular Bag Tear; No Patient Involvement; Vitrectomy

  MAUDE report 8955202 ↗
• InjuryJul 25, 2019Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT THE LEAD HAPTIC CAME OUT STRAIGHT INSTEAD OF CURVED. REPORTEDLY, THIS WAS A RESULT OF A LOADING ISSUE. CUSTOMER INDICATED THAT THEY DID NOT USE THE APPROVED/RECOMMENDED CARTRIDGE WITH THE LENS. A VITREOUS LEAK WAS FOUND SO THE LENS WAS REMOVED AND A NEW, NON JOHNSON & JOHNSON SURGICAL VISION, INC. (JJSV) LENS WAS PLACED. A VITRECTOMY WAS REQUIRED. PATIENT WAS REPORTED AS FINE POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy; Vitreous Loss

  MAUDE report 8827751 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 13.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING PAIN, BLURRY VISION, DISCOMFORT AND VISUAL DIFFICULTY POST INITIAL IMPLANT. A MODEL ZCT150 16.0 DIOPTER LENS WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT REQUIRED. PATIENT NOTED AS RECOVERED POST EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Pain; Visual Disturbances

  MAUDE report 8201929 ↗
• MalfunctionDec 19, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT ONCE THE INTRAOCULAR LENS WAS IMPLANTED AN IMPERFECTION WAS NOTICED IN THE MIDDLE OF THE LENS HENCE THE LENS WAS REMOVED AND REPLACED IN THE SAME SURGICAL PROCEDURE. LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS REPORTED TO BE DOING FINE. THE REMOVED LENS WAS CUT IN HALF AND DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8177790 ↗
• InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 WITH USE OF A MODEL 1MTEC30 CARTRIDGE. POST-OPERATIVELY, THE SAME DAY AS SURGERY, THE PATIENT WAS DIAGNOSED WITH SNOWSTORM, WHICH CLEARED WITH INTENSE STEROIDS. THE DOCTOR ALSO STATED THE PATIENT HAD SIGNIFICANT ENDOTHELIAL FOLDS-EDEMA AND FIBRIN. THE CASE WAS ROUTINE - NOTHING OUT OF ORDINARY, THIS CASE SEEMED MORE C/W TASS LIKE PRESENTATION. REPORTEDLY, THE PATIENT MIGHT HAVE TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AS WELL. IN ADDITION, THE PATIENT RECEIVED TOPICAL ANTIBIOTICS ALONG WITH INTENSE STEROIDS AND OMIDRIA. NO IOL EXPLANT HAS BEEN OR WILL BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE INTRAOCULAR LENS AND A SEPARATE REPORT WILL BE PROVIDED FOR THE CARTRIDGE.

  Patient problems: Edema; No Code Available

  MAUDE report 6982395 ↗