TECNIS IOL PCB00 (REF PCB0000125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474558113), received between May 9, 2017 and Oct 17, 2019 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS, MODEL PCB00 12.5 DIOPTER WAS INSERTED, THE PATIENT'S CAPSULE BROKE. A VITRECTOMY WAS PERFORMED AND SUTURES WERE USED. THE LENS WAS REMOVED AND REPLACED WITH A Z9002 IOL. THE OUTCOME OF THE PATIENT AT DISCHARGE WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 9200637 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SAME SURGICAL PROCEDURE, THE PCB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT¿S LEFT EYE FOR UNKNOWN REASONS. REPORTEDLY, A VITRECTOMY WAS PERFORMED AND A ZA LENS WAS IMPLANTED AS A REPLACEMENT. NO INCISION ENLARGEMENT WAS REQUIRED AND THE PATIENT WAS REPORTED AS RECOVERED. THE PCB00 LENS WAS DISCARDED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 8109752 ↗
• MalfunctionSep 4, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS HAD HAPTIC STUCK IN THE LOADER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR NO MEDICAL INTERVENTION PERFORMED. PATIENT WAS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841609 ↗
• InjuryJun 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AFTER THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL) PCB00 +12.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 7563662 ↗
• MalfunctionFeb 23, 2018Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT THE SCRUB NURSE PREPARED THE INTRAOCULAR LENS (IOL). THE SURGEON MOVED THE PLUNGER FROM THE LOADED TO THE LOCKED POSITION. WHEN IT LOCKED, HE HEARD A STRANGE SOUND AND THEN LOOKED DOWN AT CARTRIDGE AND SAW THAT IT HAD CRACKED AND THE IOL WAS STICKING OUT OF THE SIDE. CARTRIDGE TIP DAMAGE WAS OBSERVED PER A PHOTO PROVIDED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 7292377 ↗
• InjuryFeb 13, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT WHEN THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL), SHE HAD TO USE MORE FORCE TO SCREW THE PLUNGER THAN USUAL AND AFTER THE IOL ENTERED THE EYE SHE DISCOVERED A BIG STAR SHAPED DAMAGE ON THE LENS BACK SURFACE. SHE THEN CUT THE LENS INTO SMALL PIECES, REMOVED AND REPLACED IT. AN INCISION ENLARGEMENT WAS PERFORMED. THE PATIENT HAD 20/20 VISION, THE WEEK AFTER SURGERY. THERE WERE NO SUTURES OR VITRECTOMY. THE REMOVED LENS WAS DISCARDED BY THE SURGICAL STAFF. IT WAS STATED DURING FOLLOW UP THAT THERE WAS NO FOREIGN MATERIAL ON THE LENS AND THE AREA OUTSIDE THE ''STAR SHAPED'' ZONE APPEARED TO BE INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 7268168 ↗
• MalfunctionOct 10, 2017Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT DURING THE INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE LENS GOT STUCK IN THE CARTRIDGE. THE TIP OF THE CARTRIDGE WAS IN THE INCISION AND THE FRONT PART OF THE LENS HAD PATIENT CONTACT TOO. REPORTEDLY, THE LENS CAME BACK OUT OF THE EYE WHEN THE CARTRIDGE WAS REMOVED FROM THE INCISION. NO INCISION ENLARGEMENT, NO SUTURES WERE USED AND NO VITRECTOMY WAS PERFORMED. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939297 ↗
• MalfunctionSep 20, 2017Bent; Bent

  IT WAS REPORTED THAT THE LENS BOX OF A PCB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) HAD A NOTE ON IT STATING THE TIP WAS BENT. REPORTEDLY, THIS WAS DURING HANDLING, BUT PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880838 ↗
• MalfunctionMay 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL) AND NOTICED VISUAL DAMAGE TO THE CENTER OF THE LENS. THE VISUAL DAMAGE WAS DESCRIBED AS A MARK BUT NOT A SCRATCH. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. ANOTHER IOL WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE DOING FINE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556079 ↗