TECNIS IOL ZA9003 (REF ZA90030135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474528888), received between Aug 1, 2017 and Jun 8, 2024 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 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 OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO UNKNOWN REASONS. REPORTEDLY, THE SYMPTOMS LASTED 28 DAYS. THE REPLACEMENT LENS WAS ANOTHER JNJ IOL MODEL ZCB00 17.0 DIOPTER IOL. IT IS UNKNOWN IF THE PATIENT WAS UNABLE TO PERFORM ANY DAILY ACTIVITIES THAT THEY WERE ABLE TO PRIOR TO SURGERY. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. IT IS UNKNOWN IF MEDICATION WAS PRESCRIBED (OUTSIDE OF STANDARD CARE) OR IF MEDICAL ATTENTION WAS REQUIRED. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19493482 ↗
• InjuryMay 25, 2023Adverse 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 RIGHT EYE DUE TO SUBJECTIVE VISUAL DISTURBANCES. THIS WAS REPLACED WITH THE SAME MODEL IOL, BUT 3.5 DIOPTER SIZE POWER HIGHER THAN THE ORIGINAL IOL. NO MEDICAL OR SURGICAL INTERVENTIONS WERE INDICATED. PATIENT FULLY RECOVERED POST-EXPLANT AND NO INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17008292 ↗
• MalfunctionJan 10, 2023Break; Break

  THE SURGERY CENTER REPORTED BENT, BROKEN HAPTIC WITH AN INTRAOCULAR LENS (IOL). THE INCISION WAS ENLARGED, THE LENS/HAPTIC WAS REMOVED FROM THE PATIENT¿S LEFT EYE WITHOUT DIFFICULTY AND REPLACED WITH A NEW IOL. THE REPORTED ISSUE DID NOT INTERFERE WITH PATIENT¿S ACTIVITIES OF DAILY LIFE. THE PATIENT OUTCOME WAS REPORTED TO BE NORMAL. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16128614 ↗
• MalfunctionAug 11, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHEN AN INTRAOCULAR LENS (IOL) WAS BEING IMPLANTED, FOREIGN MATTER LOOKED LIKE A PART OF THE HAPTIC WAS OBSERVED IN THE PATIENT¿S EYE, AND IT WAS REMOVED. THERE WAS NO PATIENT INJURY. THERE WAS NO RETURNING PRODUCT BECAUSE THE LENS REMAINS IMPLANTED. THE IMPLANTATION METHOD WAS PROPER, AND THERE HAD BEEN NO FEELINGS OF STRANGENESS OR RESISTANCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214684 ↗
• MalfunctionJul 8, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LOADING ISSUE THAT DOCTOR CAUGHT HAPTIC WHEN LOADING AND THE HAPTIC WAS BENT/ BROKEN. THERE WAS CONTACT WITH PATIENT'S OPERATIVE EYE, HOWEVER, WAS NOT INSERTED. THE PATIENT HAS RECOVERED. THERE WAS NO INCISION ENLARGEMENT REQUIRED. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14967258 ↗
• MalfunctionApr 22, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS COMPROMISED UPON INSERTION INTO THE PATIENT'S LEFT (OS) EYE. THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF SAME MODEL AND DIOPTER. HOWEVER; THE SECOND LENS ALSO HAD THE SAME ISSUE AS THE FIRST LENS. THEREFORE; A THIRD LENS WAS USED TO COMPLETE THE PROCEDURE. THE REPLACEMENT LENS IS AN ANTERIOR CHAMBER LENS. THERE WAS NO HARM OR INJURY TO THE PATIENT. PATIENT OUTCOME POST SURGERY WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT REPRESENTS THE SECOND LENS. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190720 ↗
• MalfunctionApr 22, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS COMPROMISED UPON INSERTION INTO THE PATIENT'S LEFT (OS) EYE. THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF SAME MODEL AND DIOPTER. HOWEVER, THE SECOND LENS ALSO HAD THE SAME ISSUE AS THE FIRST LENS; THEREFORE, A THIRD LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. PATIENT OUTCOME POST SURGERY WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT REPRESENTS THE FIRST LENS. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190623 ↗
• MalfunctionMar 14, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS LOADED, HOWEVER, THE HAPTICS WERE NOTED TO BE BENT. THE LENS WAS PARTIALLY INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, THE LENS WAS REMOVED DUE TO THE ISSUE. THERE WAS NO INJURY. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13764687 ↗
• MalfunctionMar 3, 2021Break; Break

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) HAD HAPTIC BENT UPON LOADING AND THE DOCTOR NOTICED AFTER INSERTING INTO EYE. DOCTOR CHOSE TO CUT LENS OUT AND GET A NEW LENS. THERE WAS CONTACT WITH CARTRIDGE TIP AND HAPTIC/OPTIC WITH EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408366 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING ASTIGMATISM. REPORTEDLY THE PATIENT HAD 0.25 DIOPTER OF ASTIGMATISM PRIOR TO CATARACT SURGERY BUT HAD 2.25 DIOPTER AFTER THE CATARACT SURGERY. HENCE A TORIC LENS WAS IMPLANTED AS REPLACEMENT LENS TO COUNTERACT THE ASTIGMATISM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10247565 ↗
• MalfunctionMar 25, 2020Contamination; Contamination

  IT WAS REPORTED THAT A CUSTOMER IS RETURNING THE ZA9003 INTRAOCULAR LENS (IOL) AND EMERALD CARTRIDGE DUE TO A COMPLAINT OF A "FILM" ON THE ZA9003. IT WAS STATED THAT THE CUSTOMER IS NOT SURE IF THE FILM IS ON THE LENS OR IF IT CAME FROM THE CARTRIDGE. IT WAS LEARNED THAT THE IOL REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE IOL SUSPECT PRODUCT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE CARTRIDGE SUSPECT PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9881696 ↗
• MalfunctionApr 4, 2019Break; Break

  IT WAS REPORTED THAT WHEN REMOVING FROM PACKAGING THE INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE BACK UP LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8485586 ↗
• InjuryDec 20, 2018Break; Break

  IT WAS REPORTED THAT A ZA9003 13.5 DIOPTER LENS WAS INSERTED INTO THE OPERATIVE EYE ON (B)(6) 2018, OPTIC DAMAGE WAS OBSERVED. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018. THERE WAS NO INCISION ENLARGEMENT REQUIRED. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8183380 ↗
• InjuryApr 20, 2018Bent; Bent

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (MODEL ZA9003 +13.5 DIOPTER) WAS INSERTED INTO THE PATIENT'S EYE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS BENT CLOSE TO THE OPTIC. REPORTEDLY, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS (SAME MODEL AND DIOPTER) DURING THE SAME SURGICAL PROCEDURE. THE INCISION WAS ENLARGED TO REMOVE THE LENS BUT NO SUTURES WERE USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7445993 ↗
• MalfunctionFeb 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE LENS WAS CONTAMINATED DURING HANDLING/PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 7261418 ↗
• InjuryAug 1, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZA9003 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE PATIENT HAVING DECREASED VISION AND WAS FOUND TO HAVE RHEGMATOGENOUS RETINAL DETACHMENT AND A DISLOCATED INTRAOCULAR LENS. THERE WAS NO INCISION ENLARGEMENT OR CAPSULE TEAR WHEN REMOVING THE LENS FROM THE EYE, HOWEVER A VITRECTOMY WAS REQUIRED. THE LENS WAS REPLACED WITH A NON-AMO INTRAOCULAR LENS. THE PATIENT WAS DISCHARGED STABLE WITH NO ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Retinal Detachment; Visual Impairment; Vitrectomy

  MAUDE report 6758513 ↗