TECNIS IOL PCB00 (REF PCB0000110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474558083), received between Jun 8, 2017 and Oct 24, 2021 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2021Break; Mechanical Jam; Break; Mechanical Jam

  CUSTOMER REPORTED LENS DAMAGED AND STUCK IN CARTRIDGE WITH A MODEL PCB00 TECNIS ITEC PRELOADED DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686765 ↗
• MalfunctionFeb 18, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT CLEARLY VISIBLE GROVES OF LITTLE STRENGTH WERE OBSERVED ON THE OPTIC OF THE LENSES 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 9723368 ↗
• MalfunctionOct 17, 2019Contamination; Contamination

  IT WAS REPORTED THAT THE CUSTOMER FOUND A VISIBLE BLACK THREAD OF ABOUT 0.6 MM IN SIZE AFTER IMPLANTATION OF A MODEL PCB00 INTRAOCULAR LENS (IOL). WHEN TRYING TO REMOVE THE PARTICLE, IT JUST VANISHED BEHIND THE ZONULES. THE CUSTOMER DOES NOT BELIEVE THAT THE PARTICLE ORIGINATES FROM THE LENS BUT CANNOT BE CERTAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9205694 ↗
• MalfunctionNov 27, 2018Deformation Due to Compressive Stress; Failure to Eject; Deformation Due to Compressive Stress; Failure to Eject

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS DEVICE HAD DEFECTIVE PLUNGER. THERE WAS NO PATIENT CONTACT. THIS WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT TIP WAS DEFORMED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8109332 ↗
• MalfunctionJun 5, 2018Difficult or Delayed Positioning; Positioning Failure; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PCB00 INTRAOCULAR LENS (IOL) WAS NOT ADVANCING PROPERLY INTO THE PATIENT'S EYE. PER ACCOUNT, THE IOL WAS PARTIALLY DELIVERED INTO THE PATIENT'S EYE AND THE LENS BECAME STUCK IN THE CARTRIDGE. AS A RESULT, THE IOL WAS REMOVED FROM PATIENT'S OPERATIVE EYE AND REPLACED WITH DIFFERENT MODEL IOL. THERE WERE NO INCISION ENLARGEMENT REQUIRED AND NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7568126 ↗
• InjuryJun 16, 2017Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT FOLD IN THE CARTRIDGE AS IT WAS GOING INTO THE PATIENT'S EYE. REPORTEDLY, THE INCISION WAS ENLARGED TO REMOVE THE LENS FROM THE ANTERIOR CHAMBER. NO SUTURE WAS USED AND NO VITRECTOMY WAS PERFORMED. ANOTHER LENS WAS IMPLANTED WITHOUT DIFFICULTIES. THE PATIENT STATUS WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6645924 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHYSICIAN HAD 2 PATIENTS WHO HAD INFLAMMATION AND POSSIBLE TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ONE EVENT OCCURRED IN MARCH AND THE OTHER OCCURRED IN (B)(6). IT WAS REPORTED THAT THEY DID A FULL REVIEW AND THE ONLY THING FOUND IN COMMON WAS THE LENS. THEY BOTH HAD A PCB00 LENS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE PCB00 11.0 DIOPTER INTRAOCULAR LENS (IOL) AND SEPARATE MDR WILL BE FILED FOR THE SECOND PCB00 LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available

  MAUDE report 6627483 ↗