TECNIS IOL PCB00 (REF PCB0000290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474558441), received between Nov 2, 2017 and Apr 8, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE INJECTION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), ONCE IN THE PATIENT'S EYE, THE LENS APPEARED WITHOUT THE PROXIMAL LOOP. THE PROXIMAL LOOP WAS INSIDE THE CARTRIDGE AFTER LENS INJECTION. THE LENS WAS EXPLANTED AND THE INCISION WAS WIDEN WHICH LENGTHEN THE SURGERY TIME. A NEW LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

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

  MAUDE report 19068077 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS (IOL) IS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946711 ↗
• MalfunctionDec 5, 2022Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT AT THE START OF THE PROCEDURE THE HAPTIC WAS ALREADY OUTSIDE AND DEFECTIVE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920514 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13065877 ↗
• InjuryJul 23, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A PCB00 INTRAOCULAR LENS (IOL), ONE OF THE HANDLES (HAPTIC) STAYED FOLDED IN THE WRONG POSITION AND CAME OUT IN THE Z POSITION. PATIENT WAS PERMANENTLY IMPAIRED. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS 6 OF 7.

  Patient problems: Eye Injury

  MAUDE report 12222354 ↗
• MalfunctionJan 9, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) OF THE TECNIS ITEC PRELOADED DEVICE WAS CRACKED IN THE INJECTOR (INSERTOR). THERE IS NO INDICATION OF PATIENT CONTACT WITH THE LENS. NO ADDITIONAL PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11143950 ↗
• InjuryOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL PCB00 +29.0 DIOPTER), THE PATIENT EXPERIENCED SEVERE POSITIVE DYSPHOPSIA. REPORTEDLY, THE SYMPTOMS WERE FIRST OBSERVED BETWEEN 1 AND 4 WEEKS POST-OP AND THEY CURRENTLY INTERFERE WITH THE PATIENT''S ABILITY TO DRIVE. IT WAS ALSO NOTED THAT THE PATIENT HAD A LIMITED YAG (YTTRIUM ALUMINIUM GARNET) 2 MONTHS POST SURGERY WHICH DID NOT RESOLVE THE SYMPTOMS. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED OR PLANNED AT PRESENT, THOUGH THE CUSTOMER IS CONSIDERING A SILICONE PIGGYBACK LENS IF THOUGHT USEFUL. PATIENT VISION IS 6/4 UNAIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8011658 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 29.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO THE PATIENT EXPERIENCING DISTANCE BLURRY VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7725468 ↗
• InjuryJul 6, 2018Difficult to Fold, Unfold or Collapse; Material Deformation; Difficult to Fold, Unfold or Collapse; Material Deformation

  A REPORTED WAS RECEIVED FROM A PATIENT COMPLAINING OF DOUBLE VISION AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION IN THE LEFT EYE (OS) ON (B)(6) 2018. REPORTEDLY, THE ISSUE BEGAN 3-4 DAYS POST-OPERATION. IT WAS NOTED THAT THE PATIENT'S PRE-OP MEASUREMENT WAS 20/25 +2.00 AND THE POST-OP MEASUREMENT ON (B)(6) 2018 WAS 20/30 +1.00. REFRACTION WAS DONE ON THE SAME DAY WITH THE TRIAL FRAME, AND THEN THE PATIENT WAS NOT EXPERIENCING DOUBLE VISION ANYMORE; HIS MEASUREMENT WAS 20/15. ADDITIONAL INFORMATION REVEALED THAT THERE WAS NO PATIENT INJURY AND NO SECONDARY SURGICAL INTERVENTION WAS REQUIRED. PATIENT STATED THAT THE SURGEON NOTICED THAT THE IOL HAD A CREASE IN IT SO IT DIDN'T UNFOLD CORRECTLY. CONSEQUENTLY, THE PATIENT DISCUSSED ANY OPTIONS WITH HIS SURGEON WHO ADVISED THAT GLASSES WOULD TAKE CARE OF THE DOUBLE VISION. THE PATIENT ALSO REPORTED HAVING GLARE, BUT THE SURGEON DID NOT ADDRESS THAT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7665968 ↗
• MalfunctionNov 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER AN IMPLANTATION OF A PCB00 29.0 DIOPTER INTRAOCULAR LENS (IOL), A LITTLE FIBER WAS NOTICED IN THE OPERATIVE EYE. THE FIBER WAS ABLE TO BE REMOVED BUT WAS DISCARDED. THERE WAS NO INCISION ENLARGEMENT. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6995554 ↗