TECNIS IOL PCB00 (REF PCB0000190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 05050474558243), received between Aug 31, 2016 and Nov 4, 2023 — classified as 22 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Crack” (13 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 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED DURING INJECTOR PROGRESSION. NO MEDICAL INTERVENTION WERE REPORTED AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070250 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT AS SOFT AS IT SHOULD HAVE BEEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519196 ↗
• MalfunctionAug 15, 2022Scratched Material; Scratched Material

  RECEIVED REPORT INDICATING THE DOCTOR NOTICED A SCRATCH ON THE INTRAOCULAR (LENS) 19.0 DIOPTER. THE SURGEON IMPLANTED A BACKUP IOL OF THE SAME MODEL BUT DIOPTER 19.5 AS THEY DID NOT HAVE A 19.0 BACKUP IOL. THERE WAS NO PATIENT INJURY. REPORTEDLY, THE ISSUE WAS NOT DUE TO ERROR. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. THE SUSPECT PRODUCT WILL NOT RETURN TO JNJ AS IT WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15230088 ↗
• MalfunctionDec 27, 2021Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance

  IT WAS REPORTED THAT AFTER IMPLANTATION ACCORDING TO THE DFU (DIRECTIONS FOR USE), THE LAST PUSH WAS GIVEN AND THE TRAILING HAPTIC UNFOLDED AND STAYED IN THE CARTRIDGE. THE HAPTIC WAS NOT FOLDED ON THE OPTIC OF THE LENS AND THE DOCTORS GOT IT OUT OF THE CARTRIDGE WITHOUT DAMAGE, REQUIRING A SECONDARY TOOL TO FREE THE LENS. THERE WAS A DELAY IN PROCEDURE; HOWEVER, NO PATIENT ISSUES REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091088 ↗
• MalfunctionNov 3, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749813 ↗
• MalfunctionOct 20, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED WHILE IMPLANTING. THERE WAS NO PATIENT INJURY AND NO INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669503 ↗
• MalfunctionAug 6, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) WAS INSERTED INTO PATIENT'S RIGHT EYE AND NOTICED THAT THERE WAS SCRATCHES ON THE IOL WHILE OBSERVING THE LENS UNDER THE MICROSCOPE. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AND WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF THE SAME MODEL AND DIOPTER. THE LENS WAS DISCARDED. THERE WAS NO PATIENT INJURY. ONE DAY POST-OPERATIVE (OP) PATIENT REPORTED BLURRY VISION, HOWEVER, NO OTHER COMPLAINTS. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12291869 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO PATIENT HAVING HYPHEMA, GLAUCOMA SYNDROME AND UVEITIS. THE REPLACEMENT LENS USED IS ANOTHER JOHNSON AND JOHNSON SURGICAL VISION LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE DONE. PATIENT WAS DOING FINE POST-OP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Glaucoma; Hyphema; Uveitis

  MAUDE report 12222333 ↗
• InjuryJul 22, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LENS WAS PREPARED ACCORDING TO INSTRUCTIONS, NO PROBLEMS WITH ADVANCEMENT AND IMPLANTATION. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THEN IT WAS FOUND THAT THE IOL WAS MISSING A HAPTIC. THE LENS WAS EXPLANTED AT A LATER DATE AND ANOTHER JOHNSON AND JOHNSON LENS OF THE SAME MODEL WAS IMPLANTED. IT WAS REPORTED THAT THE INCISION WAS ENLARGED DURING THE EXPLANT PROCEDURE. PATIENT PRESENTED WITH CORNEA GUTTATA THE DAY OF THE EXPLANT, PRE-OPERATIVE VISUAL ACUITY (VA) WAS 0.5. DOCTOR BELIEVED THERE WERE FEWER ENDOTHELIAL CELLS REMAINING AFTER THE EXPLANT. HOWEVER, EDEMA WAS OBSERVED ON THE FIRST DAY WITH 0.1 VA. VA READINGS ON THE SECOND DAY OF THE IOL EXCHANGE WAS 0.5. THE SURGEON HAS NOT RECOMMENDED ANY ADDITIONAL INTERVENTION AS PATIENT HAS NOT REACHED VISUAL STABILITY. FOLLOW-UP REVEALED THAT THE PATIENT'S OPERATIVE EYE WAS THE RIGHT SIDE AND THAT THE MISSING HAPTIC WAS NOT FOUND IN THE EYE. EMMETROPIA WAS THE TARGET; HOWEVER, PLANNED RESULT WAS NOT ACHIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Eye Injury

  MAUDE report 12215594 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP CRACKED WHEN THE LENS SHOULD BE INJECTED. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/APPLICATION. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. THE CUSTOMER HAS NO FURTHER INFORMATION THAN WHAT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208011 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE TIP CRACKED WHEN THE LENS SHOULD BE INJECTED. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/APPLICATION. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. THE CUSTOMER HAS NO FURTHER INFORMATION THAN WHAT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207993 ↗
• MalfunctionJul 15, 2021Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  RECEIVED REPORT INDICATING THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT WORK PROPERLY. THE TECHNICIAN LOADED THE LENS AND THE LENS CAME OUT THROUGH THE SIDE. THERE WAS NO PATIENT CONTACT AND NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF DIFFERENT MODEL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177702 ↗
• MalfunctionJul 15, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT WHILE INSERTING THE INTRAOCULAR LENS (IOL) INTO THE OPERATIVE EYE, IT WAS NOTICED THE HAPTIC WAS BENT/BROKEN. THERE WAS PATIENT CONTACT HOWEVER, THE EXTENT OF THE CONTACT IS UNKNOWN. REPORTEDLY, THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171501 ↗
• MalfunctionMar 17, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER INSERTION OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, A SCRATCH WAS OBSERVED. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11500349 ↗
• MalfunctionMar 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED DURING PRODUCT HANDLING AND PRIOR TO INSERTION, THE HAPTIC DETACHED FROM THE PRE-LOADED INTRAOCULAR LENS (IOL) AND THERE WAS NO PATIENT CONTACT. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408446 ↗
• MalfunctionFeb 26, 2021Difficult to Advance; Mechanical Jam; Material Split, Cut or Torn; Difficult to Advance; Mechanical Jam; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS STUCK IN CARTRIDGE. THE LENS WAS PARTIALLY INSERTED. THE EVENT WAS OBSERVED WHILE INSERTING LENS INTO EYE. THERE WAS NO INCISION ENLARGEMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11386928 ↗
• MalfunctionFeb 12, 2021Break; Break

  THE ACCOUNT REPORTED THAT THE INTRAOCULAR LENS WAS FOUND TO BE DEFECTIVE ON ATTEMPTED INSERTION, SO INSERTION WAS ABORTED AND A NEW INTRAOCULAR LENS WAS OBTAINED. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. NO COMPLICATION WITH THE PATIENT WAS REPORTED. IT WAS NOTED THAT THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322757 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE USING A PCB00 MODEL INTRAOCULAR LENS(IOL) HAD TO DO VITRECTOMY DUE TO BREAK IN CAPSULE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11232281 ↗
• InjuryJan 15, 2021Break

  IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. NOTE ON FORM SAYS THAT THERE WAS A PROBLEM WITH THE EYE. NO FURTHER INFORMATION PROVIDE.

  Patient problems: Eye Injury

  MAUDE report 11181589 ↗
• MalfunctionJan 13, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THE DOCTOR HAD TO CUT IT BACK OUT BECAUSE OF SCRATCHES. IT WAS NOTED THAT THE FACILITIES DISPOSED OF THE FACILITIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159851 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IS PLANNED TO BE REMOVED FROM THE PATIENT¿S LEFT EYE DUE TO PATIENT HAVING BLURRY VISION. IT WAS NOTED THAT THE PATIENT ORIGINALLY HAD A STANDARD MONOFOCAL PLACED AND WILL EITHER NEED ANOTHER MONOFOCAL OF A DIFFERENT POWER OR A TORIC LENS. IT WAS LEARNED THAT THE PRE-OP VISUAL ACUITY (VA)WAS 20/80 POST-OP VA WAS 20/50. ALSO, THE CONTACT PERSON STATED THAT THE SURGERY CENTER DOES NOT RETURN THE PRODUCT, IT GETS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 10909775 ↗
• MalfunctionNov 20, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A TECNIS PRELOADED INTRAOCULAR LENS (IOL) HAD UNFOLDING ISSUE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. THERE IS NO INDICATION OF SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10873334 ↗
• MalfunctionAug 28, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) MODEL PCB00 DID NOT ADVANCE COMPLETELY OUT OF THE CARTRIDGE AND IOL WAS IN PATIENT RIGHT EYE THEN REMOVED. PROCEDURE WAS COMPLETED USING NEW LENS OF DIFFERENT MODEL ZCB00 BUT SAME DIOPTER. THERE WAS NO PATIENT INJURY AND PATIENT IS DOING GREAT POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464025 ↗
• MalfunctionAug 24, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING A CATARACT SURGERY, THE INTRAOCULAR LENS DID NOT CAME OUT OF THE INSERTER. LENS WAS PARTIALLY DELIVERED. NO PATIENT INJURY, NO WOUND ENLARGEMENT, NO VITRECTOMY PERFORMED. ALL THE INFORMATION AVAILABLE HAVE BEEN SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445745 ↗
• InjuryJun 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A 3-PIECE ZA9003, SERIAL NUMBER (B)(4) IOL DURING THE INITIAL PROCEDURE, BECAUSE OF AN UNPLANNED VITRECTOMY. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 10151336 ↗