TECNIS IOL ZA9003 (REF ZA90030200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 05050474529014), received between Aug 31, 2016 and Jan 29, 2025 — classified as 34 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL LENS HAD TO BE REPLACED WITH AN ANTERIOR CHAMBER (AC) LENS DUE TO PATIENT MOVEMENT DURING THE PROCEDURE. THE AC LENS WAS SUBSEQUENTLY REMOVED, AND AN UNKNOWN INTRAOCULAR LENS (IOL) WAS PLACED. THERE WAS UNKNOWN PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21267463 ↗
• MalfunctionOct 9, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS GOT SCRATCHED, LEADING TO ITS REMOVAL FROM THE EYE. IT WAS REMOVED AND REPLACED WITH ANOTHER SAME MODEL LENS SUCCESSFULLY INSERTED IN ITS PLACE. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409129 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. DURING THE INITIAL FOLLOW-UP, WE LEARNED THAT THE LENS BROKE WHILE BEING PLACED IN THE CARTRIDGE, WITH NO PATIENT CONTACT. HOWEVER, NEW INFORMATION LATER REVEALED THAT DURING THE PROCEDURE, ONE OF THE LENS HAPTICS EMERGED FROM THE INJECTOR BROKEN AND MADE CONTACT WITH THE PATIENT. THE LENS HAD BEEN PREVIOUSLY UNPACKED FROM ITS CONTAINER AND WAS CONFIRMED TO BE INTACT AT THAT TIME. A REPLACEMENT IOL WAS SUCCESSFULLY IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314754 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OPERATIVE EYE. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF BLURRY VISION/VISUAL DISTURBANCE. THE EXPLANTED IOL WAS REPLACED WITH AN AR40E 19.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. DEVICE DIRECTIONS FOR USE WERE FOLLOWED. THE FOLLOWING ARE ALL UNKNOWNS: IF THE PATIENT IS UNABLE TO ACCOMPLISH DAILY TASKS THAT HE/SHE WAS ABLE TO DO PRIOR TO SURGERY, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), OR IF MEDICAL ATTENTION WAS REQUIRED. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19102364 ↗
• MalfunctionMar 21, 2024Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT AFTER THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, THE LENS WAS NOT SITTING CORRECTLY. IT WAS NOTED THAT THE HAPTICS WERE BENT. INCISION ENLARGEMENT WAS REQUIRED. THE LENS WAS REMOVED FROM THE EYE AND NO LENS WAS PLACED; THE PATIENT WAS LEFT APHAKIC. THE PATIENT WILL SEE A RETINA SPECIALIST. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949115 ↗
• MalfunctionMar 21, 2024Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT AFTER THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, THE LENS WAS NOT SITTING CORRECTLY. IT WAS NOTED THAT THE HAPTICS WERE BENT. INCISION ENLARGEMENT WAS REQUIRED. THE LENS WAS REMOVED FROM THE EYE AND NO LENS WAS PLACED; THE PATIENT WAS LEFT APHAKIC. THE PATIENT WILL SEE A RETINA SPECIALIST. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949098 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO UNKNOWN REASON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING SAME MODEL WITH DIFFERENT DIOPTER BACKUP LENS. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND VITRECTOMY WAS NOT REQUIRED. THE LENS WAS REPLACED WITH SAME MODEL LENS WITH DIFFERENT DIOPTER. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18528261 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF NEGATIVE DYSPHOTOPSIA; INFORMATION REGARDING A REPLACEMENT IOL IS UNKNOWN. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS REPORTED AS 20/25-1 AND BCVA POST-OPERATIVE IS UNKNOWN. THERE WAS NO INCISION ENLARGEMENT, NO PROCEDURAL DELAY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER IT IS UNCERTAIN IF THE PATIENT IS UNABLE TO ACCOMPLISH DAILY ACTIVITIES THAT HE/SHE WAS ABLE TO PRIOR TO SURGERY. IT IS ALSO UNKNOWN IF FURTHER MEDICAL ATTENTION WAS REQUIRED OR IF PRESCRIPTION MEDICINE WAS PROVIDED (OUTSIDE OF STANDARD CARE). PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17980963 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597558 ↗
• InjuryJul 24, 2023Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) UNFOLDED INCORRECTLY, CAUSING THE IOL TO BEND, RENDERING IT UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER SIZE. THE INCISION WAS ENLARGED AND SUTURE(S) WERE REQUIRED HOWEVER, THERE WAS NO PATIENT INJURY. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17386091 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT A PARTIALLY INSERTED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO BENT/BROKEN HAPTIC AND LOADING ISSUE. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244707 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT CANNOT READ ANYTHING WITH HER OPERATED EYE (LEFT EYE) FOR > 1 MONTH NOW AFTER BEING IMPLANTED THE INTRAOCULAR LENS (IOL). IT WAS LEARNED THAT THE PATIENT CONSIDERS THE VISUAL PROBLEM DEBILITATING PRECISELY BECAUSE SHE IS UNABLE TO PERFORM HER REGULAR ACTIVITIES, WHICH SHE COULD STILL DO BEFORE CATARACT SURGERY AND LENS IMPLANTATION. SHE IS UNABLE TO SEE SMALL DETAILS IN FIGURES AND NAMES, BOTH UP CLOSE AND FROM A DISTANCE, AND AT NIGHT, CAR HEADLIGHTS AND LAMPS BOTHER HER A LOT BECAUSE SHE SEES EVERYTHING BLURRY AND OVERLY BRIGHT. IT WAS NOTED THAT THE VISUAL ISSUES IMMEDIATELY OCCURRED AFTER REMOVING THE BANDAGE. COMPUTERIZED CORNEAL TOPOGRAPHY (TOPOGRAPHY) OF THE LEFT EYE AND OPTICAL COHERENCE TOMOGRAPHY (OCT) MACULAR OF THE LEFT EYE WERE TO BE PERFORMED IN THE COMING WEEK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17088315 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN DURING INJECTION INTO THE PATIENT'S OPERATIVE EYE. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639082 ↗
• InjuryNov 28, 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 LEFT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED, HOWEVER, THE INCISION WAS ENLARGED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 15874780 ↗
• InjuryNov 15, 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 A PATIENT¿S LEFT EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. THE ISSUE WAS FIRST NOTICED DURING POST-OP EXAMINATION AND DAILY ACTIVITIES OF THE PATIENT SIGNIFICANTLY AFFECTED. ANOTHER JOHNSON AND JOHNSON LENS OF THE SAME MODEL, BUT A DIFFERENT DIOPTER (21.5 D) WAS SUCCESSFULLY IMPLANTED AS THE REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED AND NO DELAY IN PROCEDURE REPORTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15799294 ↗
• InjuryNov 10, 2022Material Fragmentation; Appropriate Device Problem Term/Code Not Available; Material Fragmentation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF VISION DAYS AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. UPON RETURNING TO THE OPERATING ROOM, BELIEVING THAT THE ISSUE WAS JUST A NEED TO REPOSITION THE LENS, THE DOCTOR IDENTIFIED THAT ONE OF THE IOL HANDLES HAD COME LOOSE. WHEN THE DOCTOR GOT INSTRUMENTS INTO THE CAPSULAR BAG, THE OTHER STRAP CAME LOOSE AS WELL. THE DOCTOR PERFORMED THE TOTAL EXPLANT (LOOPS AND OPTIC ZONE), AND THE PATIENT WAS LEFT APHAKIC, WITH A NEW SURGERY SCHEDULED AT A LATER DATE TO IMPLANT A NEW LENS. IT WAS NOTED THAT THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS USED FOR YAMANE SCLERAL FIXATION SURGERY ON THE RIGHT EYE. THE YAMANE FIXATION SURGERY WAS QUICK AND UNEVENTFUL. IN THE 30-DAY POSTOPERATIVE PERIOD, IT WAS FOUND THAT ONE OF THE HAPTICS HAD COME LOOSE FROM THE LENS BODY. THE PATIENT DENIES TRAUMA OR OCULAR ITCHING DURING THE POSTOPERATIVE PERIOD. THE IMPLANT SURGERY WAS (B)(6) 2022. THE SECONDARY SURGERY WHERE THE LENS WAS REMOVED AND THE EYE WAS LEFT APHAKIC WAS ON (B)(6) 2022. PRIOR TO THE IMPLANT SURGERY, THE PATIENT WAS ALREADY APHAKIC WITHOUT CAPSULAR SUPPORT AND ¿VITRECTOMIZED¿ BEFORE THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 15771322 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BENT AND WAS NOT IMPLANTED INTO PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280324 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION/APPLICATION THE INTRAOCULAR LENS (IOL) HAPTIC/LEG WAS FOUND TO BE BROKEN. PRODUCT AVAILABILITY IS UNKNOWN. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099775 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, HAD TO BE CUT OUT AS DEFECT WAS NOTED. NO OTHER INTERVENTION WAS REQUIRED AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14993228 ↗
• InjuryMay 5, 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 LEFT EYE DUE TO DYSPHOTOPSIA, BLURRY VISION, GLARE, HALOS WORSENING OVER 4 MONTHS; DAILY ACTIVITIES SIGNIFICANTLY AFFECTED. PRE-OP VISION 20/40; POST-OP VISION 20/30 -2. EXPLANTED LENS WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14294573 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC BROKE AND THE INTRAOCULAR LENS (IOL) WAS THEREFORE WAS NOT IMPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636275 ↗
• MalfunctionDec 29, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111766 ↗
• InjuryDec 29, 2021Break; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Break; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury

  MAUDE report 13103748 ↗
• InjuryNov 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE CUSTOMER WAS UNHAPPY WITH THE IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 12837229 ↗
• InjuryNov 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE CUSTOMER WAS UNHAPPY WITH THE IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 12837208 ↗