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

Model Number	PCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was not implanted; therefore, not explanted.(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
After the second step, the cartridge of the preloaded device didn¿t seem right.The user saw an extra piece of plastic at the end of the cartridge.It was reported that this could cause a tear in the capsular bag.Therefore, the surgeon decided not to implant the intraocular lens (iol) and took another one.There was no patient injury or enlargement of the wound.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 5/2/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.The plunger was observed in advanced position and the cartridge was correctly engaged into lower body of the pcb00 device.No assembly error and/or defect related to manufacturing process were observed.Visual inspection at 10x microscope magnification was performed dent/distortion was observed at the cartridge tip.The lens was observed stuck at the cartridge tube.However, the extra piece of plastic reported was not observed.Therefore, the reported issue was not verified.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 device.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: 6487720
• Report Number: 2648035-2017-00666
• Device Sequence Number: 1289975
• Product Code: HQL
• UDI-Device Identifier: 05050474558175
• UDI-Public: (01)05050474558175(17)190419
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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: 04/19/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1