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

Model Number	PCB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no indication that the lens was explanted.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during implantation of an intraocular lens (iol), model pcb00, the surgeon noticed about five (5) pieces of brown debris, of which about three (3) went into the patient's eye and were subsequently removed.There were no patient issues reported post-op.
Additional Manufacturer Narrative
Device evaluation: the preloaded delivery system was returned at the manufacturing site for evaluation.Visual inspection revealed a piece of brown debris on the cartridge's tip.The customer's reported complaint was verified.The debris was analysed using the fourier transform infrared (ftir) spectroscopy.The results revealed that the debris was probably a mixture, possibly composed of some or all of the following: polyamide, various salts, silicates, sulfates, phosphates, titanium dioxide, possible iron oxide, possible iron/chromium alloy with the information provided, there was not sufficient evidence to associate the debris found to the manufacturing process.The source of the material cannot be determined.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was verified.All pertinent information available to abbott medical optics 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: 6084710
• Report Number: 2648035-2016-01766
• Device Sequence Number: 13605997
• Product Code: HQL
• UDI-Device Identifier: 05050474558403
• UDI-Public: (01)05050474558403(17)190303
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2016

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: 03/03/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 12/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR