TECNIS IOL ZCB00 (REF ZCB0000105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474531529), received between Oct 25, 2016 and Nov 4, 2020 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING BLURRED VISION AND SEE''S RAYS LIKE A SWORD OF LIGHT WHEN HE DRIVES AT NIGHT WITH AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE. ABOUT TWO WEEKS AFTER SURGERY IN THE SECOND EYE (RIGHT EYE), THE PATIENT STARTED DRIVING AT NIGHT AND NOTICED THE HEADLIGHTS ON ON-COMING TRAFFIC LOOKED LIKE RAYS OF LIGHT COMING OFF OF IT. THE VISUAL ISSUE SIGNIFICANTLY INTERFERES WITH NIGHT DRIVING. THE PATIENT IS SCHEDULED TO HAVE A LASER TREATMENT ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 10783503 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT SEE WELL WITH THE INTRAOCULAR LENS (IOL), THEREFORE, THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9635247 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A CHANGE IN PATIENT ANATOMY AND THERE WAS NO ISSUE WITH THE LENS. HOWEVER, A VITRECTOMY WAS REQUIRED. IT IS UNKNOWN IF THE VITRECTOMY OCCURRED PRIOR TO PATIENT CONTACT OR DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8525230 ↗
• InjuryMar 21, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL) BROKE OFF DURING IMPLANTATION INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS, MODEL UNKNOWN, WITH SMALLER DIOPTER (+10,0 DIOPTER). REPORTEDLY, THERE WAS A DELAY IN THE SURGERY PROCEDURE AND THE PATIENT NEEDED SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6423008 ↗
• InjuryOct 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A HYPEROPIC SURPRISE. THE ZCB00 10.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2016 AND WAS REPLACED WITH THE SAME MODEL ZCB00 LENS, A LARGER 20.5 DIOPTER. PATIENT'S VISION IMPROVED AFTER IOL EXCHANGE AND PATIENT IS HAPPY WITH SURGERY OUTCOME. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS REQUIRED. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): SC (SANS CORRECTED) (20/40-2). VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): SC (CF) (COUNTING FINGERS)PINHOLE: 20/70. VISUAL ACUITY POST-OP (POST-REPLACEMENT): SC (20/50). TREATMENT OR PRESCRIPTION GIVEN BY THE DOCTOR: BESIVANCE, LOTEMAX GEL, PROLENSA.

  Patient problems: No Code Available

  MAUDE report 6056188 ↗