TECNIS IOL PCB00 (REF PCB0000275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474558410), received between Dec 7, 2016 and May 8, 2023 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 21, 2018Terminated

   Expired intraocular lenses were distributed.

   Z-0464-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, A EXTRA MATERIAL OF UNKNOWN ORIGIN WAS OBSERVED IN THE PATIENT'S OPERATIVE EYE. THE MATERIAL WAS REMOVED DURING THE ASPIRATION STAGE. THE LENS REMAINS FULLY IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS ISSUE OCCURRED TWICE DURING THE SURGERY DAY. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER INCIDENT AND LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891649 ↗
• MalfunctionApr 21, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ON A PRELOADED PRODUCT WAS DEFECTIVE. UNKNOWN ON WHAT EXACTLY WAS WRONG WITH THE IOL. ALSO, UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. PER FAXED DOCUMENT THE IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791811 ↗
• MalfunctionNov 15, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A PRELOADED PRODUCT HAD AN INSERTER MISFIRE. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814672 ↗
• InjurySep 25, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED/REPLACED WITHIN THE INITIAL SURGERY DUE TO BEING STUCK IN THE CARTRIDGE WITH PATIENT CONTACT. AN INCISION ENLARGEMENT WAS REQUIRED. ANOTHER LENS, A MODEL ZA9003 25.5 WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9114520 ↗
• MalfunctionSep 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ITEC WAS PREPARED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU). THE LENS DID NOT UNFOLD IN THE EYE, THE HAPTICS STUCK TO THE OPTICS AND COULD NOT BE RELEASED SO THE LENS WAS REMOVED AGAIN. NO INCISION ENLARGEMENT WAS REQUIRED AND NO PATIENT INJURY WAS REPORTED. ANOTHER INTRAOCULAR LENS (IOL) WAS IMPLANTED SUCCESSFULLY INSTEAD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8990821 ↗
• MalfunctionMay 23, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE LENS GOT STUCK DURING THE IMPLANTATION AND WHILE THE LENS WAS ALREADY IN CONTACT WITH THE EYE. NO PATIENT INJURY OR OTHER ADVERSE EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8638741 ↗
• InjuryDec 11, 2018Adverse 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 IMPLANTED INTO A PATIENT¿S LEFT EYE. THE PATIENT BECAME PHOTOPHOBIC POST IMPLANT. THERE WAS NO REAL INFLAMMATION, BUT THERE WAS SOME DRYNESS FROM DROPS WHICH THE DOCTOR SAID WAS WEIRD. THE DOCTOR CLAIMED THAT THE PATIENT HAD PERSISTENT PHOTOPHOBIA 1.5 MONTHS POST IMPLANT. THROUGH FOLLOW UP IT WAS LEARNT THAT PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/70, POST-OP BCVA 20/25. NO SURGICAL INTERVENTION WAS REQUIRED. COMMENTS WERE THAT EVENT IS NOT A PRODUCT ISSUE, BUT RATHER A COMMON SYMPTOM AFTER CATARACT SURGERY, BUT THIS PATIENT HAD WORSE PHOTOPHOBIA THAN MOST. ALTHOUGH THE PHOTOPHOBIA SYMPTOM IS IMPROVING. THE LENS REMAINS IMPLANTED AND THE PATIENT IS BEING TREATED WITH A LONG LOTEMAX TAPER AND XIIDRA. THERE IS NO PAIN NOTED, VISION IS GREAT, JUST PHOTOPHOBIA.

  Patient problems: Dry Eye(s); No Code Available

  MAUDE report 8154030 ↗
• MalfunctionAug 23, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PCB00 27.5 DIOPTER LENS WAS TORN WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7811810 ↗
• InjuryApr 10, 2017Crack; Crack

  IT WAS REPORTED THAT THE PRELOADED PCB00 DEVICE HAD A DAMAGED DISTAL END OF THE CARTRIDGE AND THE POSTERIOR CAPSULE RUPTURED. THE TIP OF THE CARTRIDGE WAS DEFORMED/ CRACKED. THE SURGEON STATES THAT THE DAMAGED DISTAL TIP OF CARTRIDGE LED TO THE POSTERIOR CAPSULE BREAK WHEN SHE ROTATED THE INJECTOR TO MANIPULATE THE INTRAOCULAR LENS (IOL) IN THE BAG. THE IOL WAS REMOVED AND DISCARDED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP IOL. THE SURGEON ENLARGED THE INCISION TO REMOVE THE IOL WITHOUT CUTTING IT. NO VITRECTOMY. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6478406 ↗
• MalfunctionFeb 9, 2017Sticking; Sticking

  IT WAS NOTICED THAT THE HAPTICS GOT STUCK TO THE POSTERIOR PART OF THE OPTIC. THE LENS WAS IMPLANTED. THERE WAS A DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INJURY. INITIALLY THREE LENSES WERE REPORTED AS IMPACTED BY THE SAME ISSUE. THIS REPORT CAPTURES THE EVENT FOR #3 OF 3. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6313373 ↗
• MalfunctionFeb 7, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), THE SURGEON FELT THAT THE LENS WAS SCRATCHED AND WAS NOT HAPPY WITH IT. REPORTEDLY, THERE WAS NO ISSUE FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6306320 ↗
• MalfunctionDec 7, 2016Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY IMPLANTED INTO THE PATIENT'S EYE AND THEN IT WAS RETRACTED OUT OF THE EYE AS IT GOT STUCK TO THE INSIDE OF THE CARTRIDGE. REPORTEDLY HALF OF LENS AND ONE HAPTIC WERE IN EYE. NO INCISION ENLARGEMENT, NO SUTURE USED AND NO VITRECTOMY PERFORMED. THE SURGEON USED A NEW LENS, SAME MODEL AND DIOPTRE. THE PATIENT WAS REPORTED BEING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6150262 ↗