TECNIS CL IOL Z9002 (REF Z900200185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474530669), received between Aug 24, 2016 and May 25, 2022 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED AND THEN REMOVED BECAUSE THE LENS WOULD NOT CENTER DUE TO TEAR IN THE CAPSULE. THE DOCTOR TRIED TO IMPLANT THE IOL IN THE SULCUS TO BEGIN WITH AND EXPLANTED IT AFTER THE LENS FAILED TO CENTER PROPERLY. THERE WAS NOT ENOUGH ZONULAR OR SULCUS SUPPORT TO KEEP THE LENS CENTERED. THE DOCTOR CONFIRMED THAT IT WAS AN EYE ANATOMY PRE-EXISTING ISSUE WHICH WAS DISCOVERED AFTER THE LENS WAS INSERTED IN THE EYE. THERE DOCTOR CONFIRMED THAT THERE WAS NO ISSUE WITH OR ALLEGATION AGAINST THE JOHNSON & JOHNSON PRODUCT. THE PATIENT WAS LEFT APHAKIC AND WAS REFERRED TO A DIFFERENT DOCTOR. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 14502127 ↗
• MalfunctionAug 27, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED IN THE PATIENT'S RIGHT EYE. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT REQUIRED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378271 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Scratched Material; Break; Inaccurate Delivery; Scratched Material

  RECEIVED REPORT INDICATING THAT, WHEN INSERTING INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) THE LENS WAS SCRATCHED AND THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S) AND NO UNPLANNED VITRECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170804 ↗
• MalfunctionFeb 3, 2021Break; Failure to Fold; Use of Device Problem; Break; Failure to Fold; Use of Device Problem

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) HAD LOADING ISSUES, FOLDING ISSUES, AND BENT/BROKEN HAPTIC. THERE WAS PATIENT CONTACT WITH THE CARTRIDGE. THIS EVENT WAS OBSERVED WHILE INSERTING THE LENS INTO THE EYE. INCISION ENLARGEMENT WAS NOT REQUIRED AND THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES OF LIFE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270879 ↗
• InjuryJan 21, 2021Material Discolored; Material Discolored

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS CLOUDY, SO IT WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. THE IOL WAS CUT TO BE TAKEN OUT OF THE PATIENT'S EYE. INITIALLY, IT WAS STATED THAT THE DOCTOR KEPT ONE OF THE THREE CUT PIECES OF THE IOL IN A BALANCED SALT SOLUTION (BSS) TO LOOK AT IT UNDER MICROSCOPE. HOWEVER, LATER IT WAS REPORTED THAT THE EXTRACTED LENS WILL NOT BE SENT TO JOHNSON & JOHNSON. THERE WAS NO INDICATION OF PATIENT DISSATISFACTION AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11211367 ↗
• InjuryJul 24, 2020Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A HAPTIC SO BIG THE SURGEON COULD NOT GET IT POSITIONED. THE CAPSULE TORE AND A VITRECTOMY WAS REQUIRED, HOWEVER, IT WAS NOT PRODUCT RELATED. THERE WAS NO INDICATION OF PATIENT INJURY, OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10318333 ↗
• InjuryApr 22, 2020Calcified; Material Discolored; Calcified; Material Discolored

  IT WAS REPORTED THAT SOMETHING LIKE A CLOUD DEVELOPED ON THE INTRAOCULAR LENS (IOL) IN THE LEFT EYE OF A MALE PATIENT. IT WAS INDICATED THAT THE PATIENT WAS TREATED WITH YAG (YTTRIUM-ALUMINUM-GARNET) LASER PROCEDURE, BUT THE SYMPTOMS ARE PERSISTENT. IT WAS CONFIRMED THAT THE REPORTED ISSUE DID NOT CAUSE VISUAL IMPAIRMENT IN THE PATIENT AND NO PATIENT INJURY WAS REPORTED. ADDITIONALLY, THE DOCTOR EXPLAINED THAT THE ENTIRE SURFACE OF THE LENS BECOMES WHITE AND CLOUDY WITH THE Z9002 LENS. THE DOCTOR THINKS THE ISSUE IS POSSIBLY CALCIFICATION BUT HE IS NOT SURE OF THE CAUSE. THE DOCTOR WILL MAKE THE DECISION IN (B)(6) 2020 AS TO WHETHER OR NOT THE LENS NEEDS TO BE EXTRACTED FROM THE PATIENT'S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9988087 ↗
• InjuryNov 21, 2019Material Opacification; Material Opacification

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT HAD MILKY WHITE LENSES IN BOTH OPERATIVE EYES. THERE WERE NO LASER MARKS. ON (B)(6) 2008 PATIENT HAD TECNIS LENS IMPLANTED IN RIGHT (OD) EYE AND ON (B)(6) 2008 HAD TECNIS LENS IMPLANTED IN LEFT (OS) EYE. LAST EYE EXAM WAS PERFORMED 2 YEARS AGO, AND PHYSICIAN SAID NOTHING HAD CHANGED AT THAT TIME. YAG CAPSULOTOMY WAS PERFORMED ON BOTH EYES. PATIENT OUTCOME WAS REPORTED AS 20/50 (RIGHT EYE) 20/200(LEFT EYE). THIS REPORT IS TO CAPTURE THE EVENT FOR THE PATIENT¿S LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT¿S RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 9351934 ↗
• InjuryAug 15, 2019Material Opacification; Material Opacification

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) HAS OPACIFIED POST IMPLANT. THE OPACIFICATION WAS FIRST NOTED IN 2014 BUT HAS WORSENED SINCE THEN. A YAG PROCEDURE WAS PERFORMED, BUT IT WAS DETERMINED THAT THE OPACIFICATION WAS DUE TO THE IOL NOT THE BAG. THE OPACIFICATION HAS CONTINUED TO WORSEN; VISUAL ACUITY IS DOWN TO 20/60. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAS EXPERIENCED A LOSS OF VISION: BCVA 20/25-1 (2014), BCVA 20/60+1 (2019). THERE HAS BEEN NO PATIENT INJURY AND NO INTERVENTION PLANNED AS OF YET. POSSIBLE IOL EXCHANGE IS IN DISCUSSION. THE PATIENT NOTES BLURRING WITH READING AND DRIVING, WHICH SIGNIFICANTLY AFFECTS HIS DAILY ACTIVITIES. THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 8900101 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL LENS IMPLANTS (B)(6) AND (B)(6) 2018 RESPECTIVELY. A Z9002 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HIS LEFT (OS) EYE ON (B)(6) 2018. AT ONE DAY POST-OPERATION, PATIENT REPORTED THAT HE FELT DIZZY, AND HAS FLOATERS NOW THAT HE DIDN¿T HAVE BEFORE. HE CONTINUES TO FEEL DIZZY AND CANNOT READ MORE THAN 20-30 MINUTES AT A TIME BECAUSE OF THE HEADACHES. HE HAS A HARD TIME FOCUSING. HIS DISTANCE VISION IS GREAT, BUT NOT AS GREAT AS HE THOUGHT IT WOULD BE, AND IT GETS WORSE AT NIGHT (NOT AS CLEAR). HE DOES NOT FEEL COMFORTABLE DRIVING AT NIGHT. HE MENTIONED HIS RIGHT EYE IS NOT AS STRONG AS HIS LEFT EYE. THIS REPORT REPRESENTS THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Dizziness; Headache; Visual Disturbances

  MAUDE report 8620682 ↗
• InjuryApr 27, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A Z9002, 18.5 DIOPTER INTRAOCULAR LENS (IOL), DURING SURGICAL EXAMINATION, THE LENS DID NOT POSITION CORRECTLY DUE TO PATIENT'S ANATOMY. AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A NON-JOHNSON & JOHNSON SURGICAL VISION LENS WAS PLACED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THERE WAS AN INCISION ENLARGEMENT REQUIRED AND SUTURES WERE PLACED. BUT NO PATIENT POST-OP INJURY. IT WAS NOTED THAT THERE WAS NO PRODUCT QUALITY ISSUE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8559547 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002, 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THE PATIENT DEVELOPED UNEXPECTED REFRACTIVE RESULT. THE IOL WAS THEREFORE EXPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND SUTURES PERFORMED. THE SUSPECT IOL WAS REPLACED WITH A Z9002, 21.5 DIOPTER IOL. IT WAS STATED THAT THE PATIENT IS DOING WELL AFTER DISCHARGE.

  Patient problems: No Code Available

  MAUDE report 8206238 ↗
• MalfunctionDec 2, 2018Break; Break

  THE SURGERY CENTER REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL), MODEL Z9002 (18.5 DIOPTER) WAS BROKEN AND IT WAS NOT NOTICED UNTIL THE LENS WAS BEING ADVANCED. REPORTEDLY, ONLY TIP OF THE CARTRIDGE CONTACTED THE PATIENT¿S EYE AND THE LENS WAS STILL IN THE CARTRIDGE WHEN THE BROKEN HAPTIC ISSUE WAS NOTICED. IT WAS INDICATED THAT THE LENS DID NOT GET STUCK IN CARTRIDGE. THE CARTRIDGE WITH LENS WAS REMOVED AND A NEW REPLACEMENT LENS WAS USED BY THE DOCTOR. THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8123097 ↗
• MalfunctionAug 27, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT Z9002 MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED TO KINKED/CRIMPED WHEN REMOVING IT FROM THE PACKAGING PRIOR TO LOADING INTO CARTRIDGE. IOL WAS NOT USED. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7820755 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE BECAUSE OF THE PATIENT EXPERIENCING MYOPIA AFTER THE INITIAL SURGERY. REPORTEDLY, AN INTRAOCULAR LENS OF SAME MODEL WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT AND NO SUTURES. PATIENT HAD VISUALLY RECOVERED WHEN DISCHARGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7445960 ↗
• MalfunctionDec 18, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS FOUND ON THE LENS WHEN REMOVING IT FROM THE PACKAGING. THERE NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 7125013 ↗
• MalfunctionNov 13, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A Z9002 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED SCRATCHED AFTER BEING INSERTED INTO THE PATIENT'S OPERATIVE EYE DURING THE SAME SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS WITH SAME MODEL AND DIOPTER SIZE. THERE WAS NO VITRECTOMY PERFORMED AND NO SERIOUS PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7026299 ↗
• InjurySep 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A Z9002 18.5 DIOPTER INTRAOCULAR LENS, A VITRECTOMY WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 6841102 ↗
• InjuryDec 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN A TRAILING HAPTIC OF A Z9002 INTRAOCULAR LENS (IOL) WAS ATTEMPTED TO BE BROUGHT INTO THE SULCUS IN PATIENT'S LEFT EYE, TEAR IN ANTERIOR CAPSULORHEXIS WAS NOTED AND THERE WAS POOR SUPPORT FOR LENS. THE IOL WAS REMOVED. VITRECTOMY PERFORMED, INCISION WAS ENLARGED AND SUTURES REQUIRED. REPORTEDLY, THE ISSUE WAS DUE TO PATIENT ANATOMY. THE IOL WAS REPLACED WITH A NON ABBOTT 16.5 DIOPTER ANTERIOR CHAMBER LENS. THERE WAS NO PATIENT INJURY POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6211752 ↗
• InjuryAug 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANTATION OF A Z9002 INTRAOCULAR LENS (IOL) IN PATIENT'S RIGHT EYE, SHE WAS DIAGNOSED WITH MYOPIA. LENS WAS EXPLANTED AND REPLACED WITH ANOTHER SAME MODEL LENS. NO INCISION ENLARGEMENT, SUTURES OR OTHER PATIENT INJURY. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5902336 ↗