MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.The lens was only partially inserted.The lens was not implanted; therefore, not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during implantation of a pcb000 13.0 diopter intraocular lens (iol), the lens would not advance.Through follow-up it was confirmed that the lens got stuck in the cartridge and would not advance.The actual lens touched the patient eye, however there was no patient injury reported.The lens was replaced with a backup lens without any other issues.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information was received stating that the patient was a (b)(6) male.Furthermore, the new information received reconfirmed that there was no patient injury.It was also learned that there was no incision enlargement, no vitrectomy and no sutures required for this event.The lens was replaced with the same model lens with a 13.0 diopter.(b)(6).Gender/sex: male.Device available for evaluation ¿ yes, returned to manufacturer on 02/16/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.The cartridge component was observed correctly engaged into lower body of the pcb00 device.The plunger component was observed in advanced position near the second detent mark.The plunger was gently pulled back and it was found not locked.Visual inspection at 10x microscope magnification was performed and the lens was observed torn and stuck at the cartridge tube.The reported issue could not be verified however a stuck in cartridge was observed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6330829
• Report Number: 2648035-2017-00297
• Device Sequence Number: 552436
• Product Code: HQL
• UDI-Device Identifier: 05050474558120
• UDI-Public: (01)05050474558120(17)190803
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/03/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR