TECNIS CL IOL Z9002 (REF Z900200215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 05050474530720), received between Sep 12, 2016 and Sep 25, 2024 — classified as 17 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NON-PRELOADED INTRAOCULAR LENS (IOL) IN 2009. SHE IS NOW (B)(6) AND THE SURGEON DESCRIBED APPEARANCE A "SPLATTER" LOOKING SUBSTANCE ON THE LENS. IT DOES NOT APPEARED TO BE THE PATIENT ANATOMY. THERE WAS PLAN TO EXPLANT THE LENS. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE VISUAL ACUITY VALUES ARE LESS THAN 20/400. THE PATIENT HAD LOST 2 OR MORE LINES OF BSCVA. (BEST SPECTACLE CORRECTED VISUAL ACUITY). THE SYMPTOMS OF VISUAL ACUITY HAD STARTED YEARS AGO. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 20303747 ↗
• MalfunctionSep 14, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC SHEARED COMPLETELY OFF AT DELIVERY INTO THE PATIENT'S EYE. THE IOL WAS CUT OUT AN REPLACED WITHOUT PATIENT ADVERSE EVENT. THE LENS WAS DISCARDED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE BACK HAPTIC WAS DETACHED FROM THE OPTIC DURING INSERTION OF THE LENS INTO THE LEFT EYE. THE LENS WAS FULLY INSERTED AND REMOVED AND REPLACED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON IOL WAS INSERTED AS REPLACEMENT (SAME MODEL AND DIOPTER). THERE WAS NO KNOWN ISSUE WITH THE CARTRIDGE OR ANYTHING THAT COULD HAVE CAUSED THE HAPTIC TO DETACH. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING FINE POST-OPERTIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422843 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE DUE TO BROKEN HAPTIC. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017524 ↗
• MalfunctionJan 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT IT WAS NOTICED BEFORE INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE THAT THE SURGICAL TECHNICIAN HAD PULLED THE HAPTIC OFF DURING LOADING. ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S RIGHT EYE, HOWEVER, THERE WAS NO INJURY TO THE PATIENT. ANOTHER LENS OF SAME DIOPTER WAS USED AS THE REPLACEMENT AND THE PATIENT HAD GOOD OUTCOME. THE ORIGINAL LENS WAS DISCARDED AT THE SITE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13164214 ↗
• MalfunctionOct 20, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT UPON INSERTION OF A Z9002 MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE IT WAS OBSERVED THAT A HAPTIC HAD BROKEN OFF FROM THE LENS. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS WERE DONE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669259 ↗
• MalfunctionSep 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT SURGEON NOTICED A TEAR IN THE INTRAOCULAR LENS (IOL) WHEN INSERTING THE LENS INTO THE PATIENT'S EYE. THEY COULD NOT DETERMINE IF THE TEAR WAS ALREADY THERE OR IF IT HAPPENED WHILE LOADING THE LENS INTO THE INSERTER AND CARTRIDGE. NO FURTHER INFORMATION IS AVAILABLE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED IN THE PATIENT'S EYE WITH NO PROBLEM. THE SURGERY WENT GREAT AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451985 ↗
• MalfunctionAug 3, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE PATIENT'S EYE, HAD PATIENT CONTACT, HAD BENT/BROKEN HAPTIC. THE CARTRIDGE WAS ALSO BROKE/CRACKED. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT. THE PATIENT HAS RECOVERED FROM SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271306 ↗
• MalfunctionJul 15, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE SURGEON NOTICED A SPLIT IN THE INTRAOCULAR LENS (IOL) WHEN HE PUSHED THE LENS PARTIALLY INTO THE PATIENT'S EYE. THE LENS WAS REMOVED FROM THE EYE ALONG WITH THE INSTRUMENT. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED THE REPLACEMENT AND THE SURGERY WENT WELL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178554 ↗
• MalfunctionJul 14, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL)WAS STIFF AND WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT BUT THE LENS WAS NOT INSERTED. THE INCISION WAS NOT ENLARGED. THERE WAS NO PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170401 ↗
• MalfunctionJul 14, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS STIFF AND WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT BUT THE LENS WAS NOT INSERTED. THE INCISION WAS NOT ENLARGED. THERE WAS NO PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170303 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT A TECNIS MONOFOCAL 3-PIECE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND THE HAPTIC WAS PARTIALLY BROKEN. THE LENS WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170138 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS A DEFECT, POSSIBLE SCRATCH IN THE INTRAOCULAR LENS (IOL). THE IOL WAS FULLY INSERTED AND REMOVED DURING SAME PROCEDURE. NO OTHER MEDICAL INTERVENTION OR PATIENT INJURY NOTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839563 ↗
• MalfunctionApr 7, 2021Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS SCRATCHED AND CHUNK MISSING OUT OF THE LENS. THERE WAS PATIENT CONTACT WHEN INSERTING INTO THE EYE. NO ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION REQUIRED. NO VITRECTOMY OR SUTURES. ANOTHER LENS SAME MODEL WAS IMPLANTED. NO FURTHER INFORMATION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632142 ↗
• MalfunctionMar 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TORN. THE LENS WAS FULLY INSERTED AND REMOVED IN THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS RECOVERED. THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564262 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT USED. THE HAPTIC BROKE WHILE BEING INJECTED INTO THE EYE. IT WAS NOTED THAT THE IOL DID TOUCH THE PATIENT. IT WAS THEN CUT OUT AND REPLACED WITH A NEW ONE. IT WAS LEARNED THAT THERE WAS NO VITRECTOMY, SUTURES, INCISION ENLARGEMENT, AND NO CAPSULE TEAR. NO POST-OP INJURIES ARE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313441 ↗
• MalfunctionJan 21, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OPENED AND THAT IT WAS DAMAGED DURING INSERTION. THERE WAS NO ADVERSE EFFECT OR INJURY REPORTED. THERE WAS NO SURGICAL INTERVENTION REQUIRED. IT WAS NOTED THAT THE LENS IS NOT AVAILABLE TO RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11210871 ↗
• MalfunctionOct 29, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 30 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10753226 ↗
• MalfunctionJul 21, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 19 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302501 ↗
• InjuryMay 21, 2020Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IS BEING RETURNED BECAUSE THE PHYSICIAN NOTICED A SCRATCH IN THE LENS DURING INSERTION. IT WAS BELIEVED THAT THE IOL WAS SCRATCHED DURING THE LOADING PROCESS. IT WAS NOTED THAT THERE WAS PATIENT CONTACT. THE IOL WAS THEN REMOVED AND A NEW LENS WAS PUT IN. THERE WAS NO VITRECTOMY, NO CAPSULE TEAR, NO PATIENT POST-OP INJURY. BUT AN INCISION ENLARGEMENT AND SUTURE WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10081259 ↗
• MalfunctionApr 27, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 79 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003452 ↗
• InjuryMar 26, 2020Break; Break

  AFTER INSERTING Z9002 21.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S RIGHT EYE CUSTOMER ACCOUNT REPORTED THE HAPTIC WAS TORN. VITRECTOMY WAS PERFORMED AND THE LENS WAS REMOVED AND REPLACED. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO PATIENT INJURY AND THE BACK-UP LENS USED TO COMPLETE THE PROCEDURE WAS A DIFFERENT LENS AND DIOPTER SIZE. IT WAS REPORTED A 10-0 NYLON SUTURE USED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9885443 ↗
• InjuryMar 13, 2020Calcified; Material Discolored; Calcified; Material Discolored

  IT WAS REPORTED THAT SOMETHING LIKE A CLOUD DEVELOPED ON THE INTRAOCULAR LENS (IOL), MODEL Z9002 20.5 DIOPTER OF PATIENTS WHO WERE PREVIOUSLY IMPLANTED WITH THIS MODEL LENS. IT WAS INDICATED THAT THE PATIENTS WERE TREATED WITH YAG (YTTRIUM-ALUMINUM-GARNET) LASER PROCEDURE, BUT THE SYMPTOMS ARE PERSISTENT. REPORTEDLY, THE PATIENTS WITH SEVERE TURBIDITY HAVE BEEN CONSIDERED FOR REMOVAL/LENS EXPLANT. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR TWO (2) OF TWO LENSES. A SEPARATE REPORT IS BEING SUBMITTED FOR THE FIRST LENS.

  Patient problems: No Code Available

  MAUDE report 9827861 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO RESIDUAL REFRACTIVE ERROR. THE REPLACEMENT LENS IS A NON-JOHNSON & JOHNSON LENS. THERE WAS NO COMPLICATIONS, INJURY, OR ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS DISCARDED. REPORTEDLY, PATIENT IS DOING FINE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9826709 ↗
• MalfunctionJan 30, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 34 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9645545 ↗
• InjuryJan 14, 2020Break; Break

  IT WAS REPORTED THAT A Z9002 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS TORN WHILE INSERTING INTO THE EYE. THE LENS WAS REMOVED AND REPLACED WITH AN IOL OF THE SAME MODEL AND DIOPTER. THE INCISION WAS ENLARGED. THE PATIENT OUTCOME IS REPORTED TO BE FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9589578 ↗