TECNIS IOL PCB00 (REF PCB0000105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474558076), received between Apr 11, 2017 and Mar 18, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT A PCB00 PRELOADED DEVICE IMPROPERLY EJECTED THE INTRAOCULAR LENS (IOL) WITH CONTACT WITH THE PATIENT'S EYE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE SAME MODEL AND DIOPTER IOL WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9846132 ↗
• MalfunctionJan 10, 2019Device Damaged by Another Device; Physical Resistance/Sticking; Separation Problem; Device Damaged by Another Device; Physical Resistance/Sticking; Separation Problem

  IT WAS REPORTED THAT A MODEL PCB00 MONOFOCAL IOL (INTRAOCULAR LENS) DID NOT LEAVE THE INJECTOR AS THE PLUNGER RIPPED THROUGH THE CARTRIDGE WALL. WHEN THE DOCTOR TOOK THE LENS OUT, THE LENS WAS MISSING THE HAPTIC. THE ISSUE WAS FIRST NOTICED WHILE THE LENS WAS BEING IMPLANTED. A NEW LENS WAS USED INSTEAD. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238320 ↗
• MalfunctionAug 27, 2018Crack; Crack

  IT WAS REPORTED THAT TECNIS ITEC PRELOADED 1-PIECE INTRAOCULAR LENS (MODEL PCB00, +10.5 DIOPTER) HAD A DEFECTIVE CARTRIDGE WHERE THE TIP WAS REPORTED CRACKED. THERE WAS NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7815629 ↗
• MalfunctionMay 26, 2017Crack; Crack

  THE TIP OF THE PRELOADED DELIVERY SYSTEM WAS FOUND CRACKED DURING INSERTION. THE INTRAOCULAR LENS (IOL) WAS NOT COMPLETELY DELIVERED INTO THE LEFT EYE, SO IT WAS REMOVED WITHOUT AN ISSUE. ANOTHER IOL WAS USED AND THE SURGERY WAS DELAYED FOR 15 MINUTES. IT WAS REPORTED THAT THE CATARACT WAS YELLOW AND LEVEL 3. THE ANTERIOR CHAMBER WAS GOOD AND THE POSTERIOR CHAMBER WAS COMPLETE. THE INCISION WAS 3.00MM, NO RESIDUAL, NO VITRECTOMY, THE IOL WAS CENTERED. THE PUPIL WAS ROUND AND 7MM AFTER SURGERY. BEST VISUAL ACUITY PRE-OPERATIVE: 0.3. BEST VISUAL ACUITY POST-OPERATIVE:1.0. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593275 ↗
• InjuryApr 11, 2017Detachment Of Device Component; Torn Material; Device Handling Problem; Detachment Of Device Component; Torn Material; Device Handling Problem

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL) TORE OFF DURING IMPLANTATION. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE AND THE INCISION WAS ENLARGED. REPORTEDLY, THE SURGEON WAS BLAMING HIMSELF BECAUSE HE NOTICED A RESISTANCE IN THE ADVANCEMENT OF THE LENS, BUT HE IMPLANTED THE LENS ANYWAY AND THE HAPTIC WAS TORN OFF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6483944 ↗