TECNIS IOL PCB00 (REF PCB0000185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 05050474558236), received between Sep 28, 2016 and Aug 22, 2023 — classified as 17 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENT'S EYE HAD AN OPTIC EDGE DEFECT. THE STABILITY OF THE IOL WAS NOT AFFECTED. THE PATIENT'S VISUAL ACUITY WAS SIGNIFICANTLY IMPROVED AFTER SURGERY. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597502 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED AND THEN REMOVED FROM THE PATIENT¿S RIGHT EYE. THE IOL WAS FULLY INSERTED WHEN A POSTERIOR CAPSULE TEAR WAS DISCOVERED. REPORTEDLY, THE INCISION WAS ENLARGED AS A BIGGER IOL WAS PLACED. THE REMOVAL AND REPLACEMENT OCCURRED DURING THE SAME PROCEDURE AND THE REPLACEMENT LENS IS A DIFFERENT MODEL ZA9003 18.0 DIOPTER. CUSTOMER THINKS THAT NO FUTURE OR MEDICAL INTERVENTION WILL BE REQUIRED SINCE THEY WERE ABLE TO FIX THE ISSUE WITH THE IOL REPLACEMENT. THE SUSPECT PRODUCT WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED TO JNJ.

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

  MAUDE report 16904722 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) IS FAULTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542202 ↗
• MalfunctionJan 5, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS VERY STICKY AFTER IT WAS FULLY INSERTED INTO THE PATIENT'S OPERATIVE EYE. THE IOL WAS CUT IN HALF AND REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109089 ↗
• MalfunctionDec 8, 2022Break; Break

  IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS FAULTY AND THAT THE LENS WAS CRACKED. THROUGH FOLLOW UP WE LEARNED THAT THE SURGERY WAS COMPLETED WITHOUT ADDITIONAL INTERVENTIONS. THE OPERATING TEAM USED A REPLACEMENT LENS AND THE SURGERY WAS COMPLETED AS NORMAL. MATERIAL IS NOT AVAILABLE AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947194 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD LENS DAMAGE AND THE LENS WAS NOT IMPLANTED INTO THE PATIENT'S EYE. PATIENT CONTACT WAS REPORTED AS UNKNOWN, HOWEVER, IT ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307403 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD LENS DAMAGE AND THE LENS WAS NOT IMPLANTED INTO THE PATIENT'S EYE. PATIENT CONTACT WAS REPORTED AS UNKNOWN, HOWEVER, IT ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307356 ↗
• MalfunctionOct 29, 2021Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT THERE WAS DIFFICULTY PUSHING THE INTRAOCULAR LENS (IOL) FORWARD IN SHOOTER AND LENS ONLY HAD ONE HAPTIC. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. THROUGH FOLLOW UP IT WAS CONFIRMED THAT THE IOL WAS DESTROYED AND THAT NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721371 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) BROKE WHILE ADVANCING IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT AND THE EVENT WAS OBSERVED DURING HANDLING BUT PRIOR TO INSERTION. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448797 ↗
• MalfunctionJul 15, 2021Crack; Mechanical Jam; Crack; Mechanical Jam

  CUSTOMER REPORTED THAT FOR ONE PRELOADED LENS (MODEL PCB00), THE TIP OF THE CARTRIDGE WAS BROKEN AND FOR ANOTHER PCB00 THE LENS WAS STUCK IN THE INSERTER. THEY COULD NOT LINK THE ISSUE TO A SPECIFIC SERIAL NUMBER. THRU FOLLOW-UP THE CUSTOMER EXPLAINED THAT THE DEFECT WAS DETECTED DURING THE PREPARATION PHASE EXCEPT FOR ONE CASE WHERE THE TIP OF THE INJECTOR WAS IN THE ANTERIOR CHAMBER; HOWEVER, THE SURGEON WITHDREW THE TIP OUT OF THE ANTERIOR CHAMBER AND USED A NEW PCB00 LENS TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER INDICATED THAT THESE TWO CASES ARE FROM WITHIN THE PAST YEAR. THEREFORE, ADDITIONAL INFORMATION IS NO LONGER AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS REPORT 1 OF 2 CAPTURING SERIAL# (B)(4). THE OTHER SERIAL# (B)(4) WILL BE CAPTURED IN A SEPARATE MDR REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177271 ↗
• MalfunctionJul 15, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE OPTIC OF THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE ISSUE WAS NOTICED DURING THE OPERATION. REPORTEDLY, IT IS UNKNOWN IF THE DEVICE HAD PATIENT CONTACT. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171274 ↗
• MalfunctionApr 13, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC AND WAS REMOVED FROM PATIENT'S RIGHT EYE. ANOTHER IOL OF SAME MODEL AND DIOPTER WAS IMPLANTED AND THAT THE SUSPECT IOL WAS REMOVAL AND REPLACED ON THE SAME DAY. THERE WERE NO INJURIES AND NO MEDICAL INTERVENTION WAS REQUIRED. THE EVENT WAS OBSERVED AFTER INSERTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11662045 ↗
• MalfunctionMar 16, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF A TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) SHEARED OFF WHEN INSERTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED WITH LENS REMOVAL SCISSORS AND FORCEPS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER SIZE. THE CUSTOMER INDICATED THAT THE LENS WAS CUT IN HALF AND DISCARDED AFTER SURGERY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499572 ↗
• MalfunctionFeb 17, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE, BENT/BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. THERE WAS NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341322 ↗
• InjuryNov 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE TECNIS PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE. DURING POST EXAMINATION THE PATIENT COMPLAINING OF SEEING HALOS AND GLARE, AND AFTER DILATING THE EYE THE LENS APPEARED OFF CENTER INFERIORLY. THE SURGEON STATED THE HAPTIC WAS NOT SITTING CORRECTLY IN THE EYE; THEREFORE, THE LENS EXCHANGE WAS WARRANTED. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. REPORTEDLY, THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10788665 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT'S CAPSULAR BAG TORE AND THE IOL WENT INTO THE VITREOUS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 10601156 ↗
• InjuryAug 13, 2020Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS SURGERY AND A PCB00 MODEL INTRAOCULAR LENS (IOL) WAS UNABLE TO BE DELIVERED INTO THE PATIENT'S EYE. IT WAS INDICATED A NON-JOHNSON & JOHNSON CARTRIDGE WAS USED. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE AND INCISION WAS ENLARGED. THE REPLACEMENT LENS USED WAS A SAME MODEL AND SAME DIOPTER. VITRECTOMY AND SUTURES WERE NOT REQUIRED. THE PATIENT WAS DOING FINE AT THE TIME OF DISCHARGE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10402214 ↗
• InjuryAug 7, 2020Inaccurate Delivery; Adverse Event Without Identified Device or Use Problem; Inaccurate Delivery; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT THE PRELOADED INTRAOCULAR LENS INTO THE PATIENT RIGHT EYE DUE TO PREVIOUS RETINAL SURGERY. NOT SURE IF THE LENS ITSELF WAS DEFECTIVE. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE WHEN DISCHARGED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10382516 ↗
• MalfunctionJul 7, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ADVANCED PRIOR TO INSERTING FULLY INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242439 ↗
• MalfunctionJun 25, 2020Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED THAT DURING CATARACT SURGERY, THE INTRAOCULAR LENS (IOL) RAN OUT OF THE CARTRIDGE AND THE DOCTOR WAS UNABLE TO PUSH THE IOL INTO THE EYE. IT WAS INDICATED THAT THE LENS WAS DAMAGED. THEY USED ANOTHER LENS TO COMPLETE THE OPERATION. THE EVENT CAUSED A DELAY IN THE PROCEDURE; HOWEVER, THE DELAY WAS NOT CLINICALLY SIGNIFICANT AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197752 ↗
• MalfunctionMar 5, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING IMPLANTATION OF A MODEL PCB00 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE THE LENS GOT STUCK IN THE CARTRIDGE. SURGEON TRIED TO IMPLANT THE IOL, BUT IT WAS NOT POSSIBLE. LENS WAS IN CONTACT WITH THE PATIENT EYE. ANOTHER IOL WAS IMPLANTED WITH NO PROBLEMS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9790614 ↗
• MalfunctionFeb 25, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THREE VISIBLE GROOVES NON-CENTRALLY WERE OBSERVED ON THE OPTIC OF THE LENS DURING IMPLANTATION. NO EXPLANT IS PLANNED AND NO IMPACT ON PATIENTS VISION HAS BEEN REPORTED. ADDITIONAL INFORMATION STATES NO INTERVENTIONS ARE PLANNED, SO FAR OUTCOME SEEMS GOOD. NO REPORTS OF HALOS OR OTHER VISUAL ISSUES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9748797 ↗
• MalfunctionFeb 18, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT CLEARLY 1 VISIBLE GROOVE ON THE PERIPHERY ON THE OPTIC OF THE LENS COULD BE SEEN DURING IMPLANTATION. NO EXPLANT IS PLANNED AND NO IMPACT ON PATIENT VISION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED STATES NO INTERVENTIONS ARE PLANNED, OUTCOME IS GOOD AND NO REPORTS OF HALOS OR OTHER VISUAL ISSUES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9719080 ↗
• MalfunctionFeb 18, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT CLEARLY VISIBLE 5 CENTRAL GROOVES ON THE OPTIC OF THE LENS COULD BE SEEN DURING IMPLANTATION. NO EXPLANT IS PLANNED AND NO IMPACT ON PATIENT VISION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED STATES NO INTERVENTIONS ARE PLANNED, OUTCOME IS GOOD AND NO REPORTS OF HALOS OR OTHER VISUAL ISSUES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9719017 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT WHO WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL), MODEL PCB00 REPORTED OF HAVING AN UNUSUAL IMAGE IN HIS LEFT EYE (OS). THE PATIENT INDICATED THAT AT NIGHT TIME OR SOMETIMES DURING THE DAY, WHEN HE IS EXPOSED TO LIGHT SOURCE, SUCH AS A TRAFFIC LIGHT, AUTO HEADLIGHT OR STREET LIGHT WITHOUT ANY GLASSES, THE CENTRAL IMAGE IS CLEAR/BRIGHTEST, BUT THERE ARE ALSO TWO LESS BRIGHT IMAGES WHICH THE PATIENT DESCRIBED THEM AS SHADOWS OR GHOST IMAGES SLIGHTLY ABOVE OR ON THE SIDES OF THE CENTRAL IMAGE. THAT IN SOME CASES IT LOOKS LIKE ''EARS'' AND IN OTHER CASES IT LOOKS LIKE DUPLICATE BUT LESS BRIGHT IMAGES OF THE CENTRAL IMAGE. THE TWO GHOST IMAGES ARE LARGEST AT A DISTANCE AND MERGE WITH THE CENTRAL IMAGE AS THE PATIENT GETS CLOSER TO THE LIGHT. THE PATIENT NOTED THAT HIS OPHTHALMOLOGIST WAS UNABLE TO EXPLAIN THE UNUSUAL IMAGES. THE PATIENT¿S DAUGHTER IS AN OPTOMETRIST AND GAVE THE PATIENT GLASSES TO WEAR. PATIENT INDICATED THAT ALTHOUGH HIS VISON IS GOOD BUT STILL EVEN WITH THE GLASSES HE HAS THE ISSUES WITH THE IMAGES. THE PATIENT SAW HIS SURGEON FEW WEEKS AGO AND HIS DOCTOR DID NOT KNOW WHAT HE IS TALKING ABOUT. THE PATIENT ALSO HAD CATARACT SURGERY IN HIS RIGHT EYE (OD) O

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9708644 ↗