TECNIS IOL PCB00 (REF PCB0000255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05050474558373), received between Oct 19, 2016 and Aug 21, 2025 — classified as 14 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT WHEN HER LEFT EYE IS COVERED, SHE IS UNABLE TO READ OR SEE CLEARLY WITH THE RIGHT EYE WHICH WAS IMPLANTED WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE PATIENT DESCRIBED HER VISION AS BLURRY AND NON-FUNCTIONAL. THE PATIENT IS UNSURE OF WHEN THE ISSUE STARTED BUT BECAME AWARE OF IT DURING A VISIT TO THE DEPARTMENT OF MOTOR VEHICLES, WHERE SHE DISCOVERED THE PROBLEM AFTER COVERING HER LEFT EYE AND REALIZING SHE COULD NOT SEE OUT OF IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 22869259 ↗
• MalfunctionMar 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION IN THE RIGHT EYE, THE CIRCULATING NURSE CHECKED WITH THE SURGEON THAT THE LENS WAS CORRECT. AFTER OPENING THE EXTERNAL PACKAGE, THE CIRCULATING NURSE FOUND THAT THE INTERNAL PACKAGE WAS DAMAGED. ACCORDING TO THE MANAGEMENT REQUIREMENTS FOR THE USE OF DISPOSABLE MEDICAL DEVICES, THE LENS WAS REPORTEDLY SUSPECTED AS CONTAMINATED. THE SURGICAL OPERATION WAS IMMEDIATELY STOPPED. THE INTRAOCULAR LENS WAS REPLACED IN TIME AFTER TIMELY COMMUNICATION WITH THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684741 ↗
• MalfunctionAug 14, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD AN OPTIC SCRATCH UPON OPENING OF THE PACKAGING. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987079 ↗
• MalfunctionMay 20, 2024Break; Break

  COMPLAINT RECEIVED FROM NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT IOL WAS IMPLANTED INTO THE PATIENT'S EYE AND IT WAS FOUND THERE WAS A CRACK IN THE OPTICAL PART OF THE LENS. THE LENS WAS REMOVED AND REPLACED. 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 19354728 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE BECAUSE AS THE IOL WAS INJECTED THE TRAILING HAPTIC WAS DAMAGED AND THE SURGEON CUT IT OUT. IT WAS REPLACED WITH THE NON-JOHNSON AND JOHNSON BACK-UP IOL. NO REPORT OF PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625608 ↗
• MalfunctionJan 25, 2022Contamination; Contamination

  IT WAS REPORTED THAT AFTER FOLLOWING THE DIRECTIONS FOR USE (DFU) AND AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE SURGEON SAW A STRING AROUND THE HAPTIC OF THE LENS. THE SURGEON REMOVED THE STRING WITH MCPHERSON IOL FORCEPS AND PUT IT INTO AN EXAM BOTTLE WITH WATER. THE STRING IS AVAILABLE FOR RETURN. THE LENS REMAINS IMPLANTED. THE PATIENT HAS FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13349018 ↗
• MalfunctionAug 18, 2021Crack; Inaccurate Delivery; Crack; Inaccurate Delivery

  IT WAS REPORTED THAT WHEN PLACING THE CARTRIDGE TIP IN THE INCISION AND PUSHING THE INTRAOCULAR LENS (IOL) WITH THE PCB INJECTION SYSTEM, THE LENS ROD BROKE THE CARTRIDGE AND STARTED TO COME OUT FROM THE SIDE THROUGH AN OPENING THAT THE ROD CAUSED WHILE BEING INJECTED. WITH THAT, THE CLIENT RELEASED THE LENS OUT OF THE CARTRIDGE WITH HALF INSIDE THE BAG AND FINISHED THE INJECTION OF THE LENS WITH FORCEPS SINCE IT WAS BENT IN THE INCISION. THERE WAS NO NOTICEABLE DELAY IN SURGERY AND THERE WAS NO NOTICEABLE PROBLEM IN THE PATIENT OTHER THAN INCREASED HANDLING IN THE PATIENT'S EYE. THE LENS WAS INSERTED AS THE DOCTOR MANAGED TO GET AROUND THIS PROBLEM WHEN INJECTING IT. THERE WAS NO EXPLANTATION, THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340105 ↗
• MalfunctionJul 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS MISSING AFTER THE IOL WAS INSERTED INTO PATIENT'S LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER IN THE SAME PROCEDURE. THERE WAS NO INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112420 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088519 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED FROM A CUSTOMER FAX, "DEFECTIVE LOOP." IT WAS REPORTED THAT A PATIENT WAS INVOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055423 ↗
• MalfunctionApr 15, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A SURGERY THE INTRAOCULAR LENS WAS INJECTED INTO THE EYE CORRECTLY. THE CONSULTANT THEN NOTICED 3 STRANDS OR FIBRES THAT HAD GONE INTO THE EYE AT THE SAME TIME AS THE LENS IMPLANT. THIS WASN'T OBSERVED DURING PROCEDURE AS THERE WAS NO MONITOR AVAILABLE. SURGEON SUCCESSFULLY REMOVED THE STRANDS USING A CAPSULORHEXIS FORCEPS. THERE WAS NO NEED TO WIDEN THE INCISION FURTHER. THIS DID NOT AFFECT THE PATIENT OR THE OUTCOME OF THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671795 ↗
• InjuryDec 10, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE INJECTOR WAS ROTATED DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE AND THE LENS GOT STUCK. THE INJECTOR WENT THROUGH IT. THE INJECTOR WAS PUSHED, HOWEVER, THE LENS REMAINED STUCK. AN INCISION OF 2.4MM WAS MADE TO IMPLANT THE ASPHERICAL LENS. AS THE INJECTOR DID NOT WORK, A SPHERICAL LENS WAS IMPLANTED BY ENLARGING THE INCISION TO 2.75MM. THERE HAS BEEN DELAY IN THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10984552 ↗
• MalfunctionMar 26, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED WHEN INJECTING A PCB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OPERATIVE EYE CUSTOMER ACCOUNT REPORTED THE LENS BEGAN TO ADVANCE AND THEN STOPPED, AND WOULD NO LONGER ADVANCE ONCE HALFWAY OUT OF THE CARTRIDGE. THE LENS DID NOT FULLY INJECT INTO THE EYE AND WHEN WITHDRAWN FROM THE EYE THE IMPLANT REMAINED IN THE CARTRIDGE; THERE WAS PATIENT CONTACT. A BACKUP IMPLANT WAS OPENED TO USE INSTEAD, AND NO FURTHER ACTION WAS TAKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884467 ↗
• InjuryFeb 25, 2020Break; Break

  IT WAS REPORTED THAT AFTER THE INSERTION OF THE INTRAOCULAR LENS, MODEL PCB00 25.5 DIOPTER INTO A FEMALE PATIENT¿S RIGHT EYE (OD), THE LENS FOLDED AND CRACKED. THEY HAD TO CUT THE LENS TO REMOVE IT FROM THE EYE. AFTER THE LENS WAS REMOVED, THE PATIENT COUGHED AND THEY HAD TO PERFORM A VITRECTOMY. IT WAS INDICATED THAT THE LENS WAS NOT REPLACED, THAT THE PATIENT WAS LEFT WITHOUT AN IMPLANT, APHAKIC AND WAS TRANSFERRED TO (B)(6) HOSPITAL. IT WAS NOTED THAT THE PATIENT IS DOING FINE POST OPERATION. THE LENS WAS THROWN AWAY AND IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 9748775 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO THE PATIENT NOT SEEING CLEARLY AT A DISTANCE. THE REPLACEMENT LENS WAS THE SAME MODEL BUT LOWER DIOPTER (23.0). THERE WAS PATIENT INJURY OR INTERVENTION REQUIRED AT EXCHANGE. PATIENT IS FINE POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9604485 ↗
• InjuryOct 3, 2019Material Opacification; Material Opacification

  IT WAS REPORTED THAT LENS CAME OUT OF INJECTOR NORMALLY AND AFTER IMPLANTING IT WAS NOTICED THAT THE LENS WAS CLOUDY. SURGEON REMOVED AND REPLACED THE LENS IN THE SAME SURGICAL PROCEDURE WITH SAME MODEL WITHOUT ANY COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT INCISION ENLARGEMENT WAS REQUIRED AND ACCOUNT WAS NOT SURE ABOUT SUTURING. PATIENT WAS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9149487 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE CUSTOMER HAD ISSUE WITH A PRELOADED DEVICE PCB00. THROUGH FOLLOW-UP WE LEARNED THAT THE POSTERIOR CAPSULE RUPTURED AS THE LENS WAS INTRODUCED INTO THE EYE REQUIRING A VITRECTOMY TO BE PERFORMED. THE LENS WAS REMOVED AGAIN FROM THE EYE AND A SULCUS LENS WAS IMPLANTED INSTEAD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 9004112 ↗
• InjuryAug 6, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT PRELOADED PCB00 DEVICE DID NOT HAVE AN INTRAOCULAR LENS IN THE CARTRIDGE WHEN SURGEON WENT TO IMPLANT. THERE WAS PATIENT CONTACT WITH THE CARTRIDGE. REPORTEDLY SUTURES WERE REQUIRED DURING THIS PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8863126 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE BECAUSE OF BROKEN CAPSULE BY DOCTOR. THERE WAS INCISION ENLARGEMENT PERFORMED. SUTURES WERE USED. THERE WAS NO PATIENT INJURY. REPORTEDLY A LENS MODEL AR40E WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 8729776 ↗
• MalfunctionFeb 5, 2019Break; Break

  CUSTOMER REPORTED A BROKEN LENS MODEL, PCB00. AS A RESULT, THE DOCTOR HAD TO USE ANOTHER LENS DURING THE SAME DAY OF THE SURGERY. THERE WAS A PATIENT CONTACT, BUT CUSTOMER DOESN'T HAVE ANY FURTHER INFORMATION. LENS WILL NOT BE AVAILABLE FOR INVESTIGATION AS IT IS DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8308768 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION. THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT, NO SUTURES REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8291580 ↗
• MalfunctionJan 15, 2019Contamination; Contamination

  IT WAS REPORTED THAT A PCB00 25.5 DIOPTER INTRAOCULAR LENS (IOL), DURING HANDLING PRIOR TO INSERTION HAD A DEBRIS ON IT. THERE WAS NO PATIENT CONTACT AND PRODUCT WILL BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8251596 ↗
• MalfunctionAug 27, 2018Crack; Crack

  IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE CRACKED PRIOR TO THE INTRAOCULAR LENS BEING INSERTED INTO THE PATIENT'S OPERATIVE EYE. THERE WAS PATIENT CONTACT, BUT THE LENS WAS NOT IMPLANTED. NO INCISION ENLARGEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7815635 ↗
• MalfunctionAug 20, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE APPLICATOR (INJECTOR) OF THE PCB00 INTRAOCULAR LENS (IOL) UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT AS IT WAS NOTICED DURING HANDLING, BUT PRIOR TO INSERTION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7798733 ↗
• MalfunctionAug 6, 2018Difficult or Delayed Positioning; Physical Resistance/Sticking; Difficult or Delayed Positioning; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL PCB00 +25.5 DIOPTER), THE TRAILING HAPTIC WAS STUCK BETWEEN THE CARTRIDGE AND THE PLUNGER. THE LENS WAS RELEASED USING A MCPHERSON FORCEPS. NO PATIENT INJURY AND NO WOUND ENLARGEMENT. THE ACCOUNT COMMENTED THAT THIS WAS A DELICATE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7751338 ↗