TECNIS IOL ZLB00 (REF ZLB00U0125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474560529), received between Apr 14, 2018 and Feb 16, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Dent in Material” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem

  THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). PATIENT REPORTED, SHORTLY AFTER THE SURGERY, COMPLAINTS OF OS BEING UNCOMFORTABLE-IRRITATING, SORE, FEELS LIKE SHE WORE CONTACT LENSES TOO LONG. SHE USES ARTIFICIAL TEARS WHEN NEEDED. PATIENT REPORTED UNCOMFORTABLE FEELING AS SAME OR BETTER NOW. PATIENT CAN SEE THE OUTLINE OF THE IOL, WHICH WAS NOTICED RIGHT AFTER SURGERY. NEAR VISION IS POOR AND HAS DIFFICULTY WORKING ON THE COMPUTER AND READING. RESULTS ARE NOT AS EXPECTED. DISTANCE VISION IS GOOD, APPROXIMATELY 20/25. OS HAD CLOUDINESS WHICH WAS CORRECTED BY LASER, CLOUDINESS IS NOW BETTER. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING POSSIBLE SWELLING OF THE RETINA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S OCULAR DEXTER (RIGHT EYE).

  Patient problems: Blurred Vision; Eye Pain; Macular Edema; Visual Disturbances

  MAUDE report 11335981 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO PATIENT INTOLERANCE OF THE MULTIFOCAL LENS. THE REPLACEMENT LENS IS A ZCU150. AT EXCHANGE, THERE WAS NO INCISION ENLARGEMENT AND NO INJURY REPORTED. THE CURRENT PATIENT STATUS WAS REPORTED AS DOING OK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9919219 ↗
• InjuryNov 5, 2019Dent in Material; Scratched Material; Dent in Material; Scratched Material

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT SEEING A DIAGONAL LINE, X2 MATCHING CREASE IN IOL (20/20 WITH LINE IN VISION). THIS WAS DESCRIBED AS SCRATCH ON IOL. AT EXPLANT THERE WAS INCISION ENLARGEMENT AND SUTURES REQUIRED, BUT NO VITRECTOMY. THE LENS WAS CUT IN HALF AND DISCARDED. NEW LENS IMPLANTED WAS THE SAME MODEL AND DIOPTER. THE IOL EXCHANGE WAS SUCCESSFUL. IT WAS ALSO MENTIONED TO ALLOW ABOUT 3.5 MONTHS FOR NEUROADAPTATION AND TO TRY DRY EYE TREATMENTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9281130 ↗
• InjuryNov 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE AT POST OP EXAM PATIENT¿S INTRAOCULAR LENS WAS DISPLACED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9273337 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZLB00 INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED GLARE WITH NIGHT DRIVING IN ONE EYE. THE SURGEON EXPLANTED THE ZLB00 LENS AND REPLACED IT WITH A SYMFONY ZXR00 +12.5 DIOPTER. THE PATIENT WASN¿T HARMED. SINCE THE PATIENT ALREADY HAD A SYMFONY IN THE OTHER UNAFFECTED EYE, THE PATIENT WANTED BOTH EYES TO MATCH. THE PATIENT¿S OUTCOME AFTER THE EXPLANT WAS REPORTED TO BE GOOD. NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY WERE REQUIRED. VISUAL ACUITY PRE-INITIAL IMPLANT: BEST CORRECTED 20/25; VISUAL ACUITY POST-INITIAL IMPLANT: 20/20 UNCORRECTED; VISUAL ACUITY POST-REPLACEMENT: 20/25 UNCORRECTED DAY ONE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 8503006 ↗
• InjuryApr 14, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A MODEL ZLB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS PLACED IN SULCUS DUE TO PATIENT MOVEMENT. A SECONDARY PROCEDURE WAS REQUIRED TO REPOSITION LENS IN THE LEFT EYE (0S). IT WAS ALSO NOTED THAT A BACKUP LENS OF A DIFFERENT MODEL AND DIOPTER SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY SUGGESTING THE LENS WAS EXPLANTED AND EXCHANGED. THERE WAS NO INCISION ENLARGEMENT, SUTURES OR VITRECTOMY REQUIRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 7431601 ↗