TECNIS IOL PCB00 (REF PCB0000090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474558045), received between Oct 11, 2016 and May 26, 2023 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT THE HAPTIC GOT STUCK IN THE INJECTOR DURING INTRAOCULAR LENS (IOL) IMPLANTATION. THE LENS WAS ALREADY INSERTED INTO THE EYE AND THE HAPTIC BECAME DISCONNECTED FROM THE IOL. THE LENS WAS EXTRACTED FOR REPLACEMENT, BUT AN ANTERIOR VITRECTOMY WAS REQUIRED DUE TO LEAKAGE. THIS LEAD TO A CHOROIDAL BLEED AND EXCESSIVE DAMAGE TO THE EYE, RESULTING IN NO LENS BEING IMPLANTED. THE POTENTIAL FOR A GOOD OUTCOME FOR VISION ARE DESCRIBED AS NOT GOOD. THE INCISION IN THE PATIENT'S EYE WAS ENLARGED, SUTURES WERE REQUIRED AND THERE WAS A DELAY OF 45 MINUTES TO THE PROCEDURE. MULTIPLE MEDICATIONS WERE PRESCRIBED, BOTH FOR INTRAOCULAR PRESSURE AND THE OTHER SYMPTOMS. THE PATIENT IS DESCRIBED AS PERMANENTLY IMPAIRED, WITH THEIR DAILY ACTIVITIES SIGNIFICANTLY IMPACTED. THEIR PRE-OPERATIVE VISION WAS DESCRIBED AS GOOD WITH A CATARACT. POST-OPERATIVE VISION WAS CLOSE WAVING HAND VISION ONLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Injury; Hemorrhage/Blood Loss/Bleeding; Loss of Vision

  MAUDE report 17015281 ↗
• MalfunctionMay 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS CONTAMINATED; THEREFORE IT WAS NOT USED. THERE WAS NO PATIENT CONTACT AND NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015262 ↗
• MalfunctionJul 2, 2021Break; Break

  IT WAS INITIALLY REPORTED THAT A MODEL PCB00 PRELOADED INTRAOCULAR LENS (IOL) WAS ALREADY DEFECTIVE WHEN IT CAME OUT OF THE PACKAGING AND COULD NOT BE USED FOR SURGERY. ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW-UP REPORTED THAT THE HAPTIC CAME OUT TWISTED AFTER PUSHING THE LENS FORWARD. THE SITE IS UNSURE IF THE LENS WAS DEFECTIVE ITSELF OR THE DAMAGE OCCURRED DURING TRANSPORTATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105847 ↗
• InjuryDec 1, 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 EXPLANTED DUE TO ANISOMETROPIA. IT WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO PATIENT POST-OP INJURY. THE PATIENT WAS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10926190 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN ANTERIOR CHAMBER LENS WAS USED DUE TO BROKEN CAPSULE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 9936439 ↗
• MalfunctionNov 15, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CARTRIDGE TIP OF THE PRELOADED DELIVERY SYSTEM, MODEL PCB00, WAS OBSERVED SPLIT WHEN THE INTRAOCULAR LENS (IOL) WAS ADVANCED THROUGH THE CARTRIDGE. PATIENT CONTACT WAS REPORTED. REPORTEDLY, THE SURGEON REMOVED THE DELIVERY SYSTEM FROM THE PATIENT'S EYE WITH THE IOL STILL INSIDE THE CARTRIDGE. THE SURGERY WAS COMPLETED WITH THE BACK-UP LENS AND THERE WAS NO PATIENT INJURY OR ANY OTHER ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073047 ↗
• MalfunctionFeb 20, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL CAME OUT OF THE CARTRIDGE INTO THE PATIENT¿S RIGHT EYE, FOLLOWING THE INTRAOCULAR LENS (IOL). THE MATERIAL APPEARED TO BE LONG, PARTIALLY CLEAR, POSSIBLY PLASTIC MATERIAL. THE IOL AND CARTRIDGE WERE OTHERWISE COMPLETELY INTACT WITH NO DEFECTS. THERE WAS NOTHING WRONG WITH THE IOL. THE IOL WAS IMPLANTED IN THE PATIENT EYE WITHOUT ISSUES. THERE WAS NO INCISION ENLARGEMENT, SUTURE, VITRECTOMY OR ANY OTHER MEDICAL/SURGICAL INTERVENTION PERFORMED. THE PATIENT WAS DOING WELL WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282832 ↗
• InjuryDec 22, 2017Break; Break

  IT WAS REPORTED THAT AFTER THE INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THAT ONE OF THE HAPTICS WAS CUT OFF AND IT WAS FLOATING IN THE EYE. REPORTEDLY, THE PREPARATION AND THE INJECTION OF THE LENS ALL WENT NORMALLY. THE SURGEON REMOVED THE HAPTIC AND THE OPTIC AND IMPLANTED A NEW LENS. NO DAMAGE WAS DONE TO THE EYE AND NO SIGNIFICANT TIME ADDED TO THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE HAPTIC SHEARED OFF IN THE INJECTOR. THE SURGEON USED A 2.75MM KERATOME AND HAD TO ENLARGE THE INCISION TO REMOVE THE LENS. THERE WAS NO POSTERIOR CAPSULE TEAR AND NO VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7141435 ↗
• MalfunctionNov 15, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SEDIMENT WAS FOUND ON THE POSTERIOR PART OF A PCB00 9.0 DIOPTER INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. REPORTEDLY, THE DOCTOR STATED THE SEDIMENT COULD BE SEEN WHEN THE LENS UNFOLDED AND WAS CONCERNED ABOUT LIFTING THE HAPTIC TO WASH UNDERNEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036033 ↗
• MalfunctionFeb 8, 2017Difficult or Delayed Positioning; Device Operates Differently Than Expected; Difficult or Delayed Positioning; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS STUCK IN THE PRELOADED DELIVERY SYSTEM. PATIENT CONTACT WITH THE LENS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT, AS PER COMMON PRACTICE, THE NURSE PREPARES THE DELIVERY SYSTEM AND HANDS IT OVER TO THE SURGEON. THE SURGEON PLACED THE CARTRIDGE LUMEN INTO THE EYE AND STARTED TO SCREW THE PLUNGER FORWARD, HOWEVER THE LENS REMAINED INSIDE THE SYSTEM AND WAS NOT COMING OUT INTO THE EYE. THE SURGEON TOOK THE CARTRIDGE OUT OF THE EYE AND ASKED FOR A NEW DELIVERY SYSTEM. REPORTEDLY, THERE WAS AN APPROXIMATE 2 MINUTE DELAY IN THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6313109 ↗
• MalfunctionOct 11, 2016Crack; Crack

  PER THE SURGEON, THERE WAS A LOT OF PRESSURE WHEN ATTEMPTING TO ADVANCE THE INTRAOCULAR LENS (IOL) AND THE PLUNGER SPLIT THE DISTAL END OF THE CARTRIDGE. NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6019058 ↗