TECNIS IOL PCB00 (REF PCB0000100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474558069), received between Sep 11, 2017 and May 4, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE. THAT THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AS THE TRAILING HAPTIC WAS MISSING UPON INSERTION. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768021 ↗
• MalfunctionApr 30, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE LEFT EYE AND REMOVED DURING THE SAME PROCEDURE AS THE TRAILING HAPTIC WAS MISSING/DETACHED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758495 ↗
• MalfunctionNov 27, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) WHEN BEING INSERTED INTO THE EYE THE IOL GOT STUCK IN THE SHOOTER. THERE WAS PATIENT CONTACT BUT THE IOL WAS NOT FULLY IMPLANTED. IT WAS LEARNED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. THE LENS WAS REMOVED AND THE BACK-UP LENS WAS IMPLANTED. THE PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9387065 ↗
• MalfunctionDec 21, 2018Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE WAS CRACKED AT THE TIP OF THE PCBOO LENS. REPORTEDLY, THIS DID NOT OCCUR DUE TO A USE/TECHNICIAN ERROR. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8190541 ↗
• MalfunctionJul 6, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT AN EXPIRED INTRAOCULAR LENS (IOL) WAS SHIPPED TO THE CUSTOMER. THE LENS WAS NOT USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7668353 ↗
• MalfunctionJul 6, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT AN EXPIRED INTRAOCULAR LENS (IOL) WAS SHIPPED TO THE CUSTOMER. THE LENS WAS NOT USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7668346 ↗
• InjurySep 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 10.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE LEFT EYE (OS) ON (B)(6) 2017. IN ADDITION, IT WAS REPORTED THAT AN ENDOSCOPIC CYCLOPHOTOCOAGULATION (EC) WAS PERFORMED FOR GLAUCOMA AFTER THE LENS WAS INSERTED AND A CAPSULAR TEAR OCCURRED ONCE THE EC PROBE WAS REMOVED. THIS WAS NOT RELATED TO THE IOL OR INSERTION. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED, BUT A VITRECTOMY WAS PERFORMED. ALSO, NO PATIENT INJURY WAS REPORTED. THE LENS WAS REPLACED WITH A 3-PIECE IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 6885248 ↗
• MalfunctionSep 11, 2017Split; Split

  IT WAS REPORTED THAT THE CARTRIDGE SPLIT WHEN FORWARDING THE PRELOADED DELIVERY SYSTEM. THERE WAS NO PATIENT INVOLVEMENT/INJURY REPORTED. DURING FOLLOW UP, IT WAS CONFIRMED THAT THE END/TIP OF THE CARTRIDGE SPLIT AS THE SURGEON WAS ABOUT TO IMPLANT. THE SURGEON STOPPED ONCE HE SAW THE SPLIT TO PREVENT PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6855887 ↗
• MalfunctionSep 11, 2017Split; Split

  IT WAS REPORTED THAT THE CARTRIDGE SPLIT WHEN FORWARDING THE PRELOADED DELIVERY SYSTEM. THERE WAS NO PATIENT INVOLVEMENT/INJURY REPORTED. DURING FOLLOW UP, IT WAS CONFIRMED THAT THE END/TIP OF THE CARTRIDGE SPLIT AS THE SURGEON WAS ABOUT TO IMPLANT. THE SURGEON STOPPED ONCE HE SAW THE SPLIT TO PREVENT PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6855876 ↗