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 Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints for this production order number has been received.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: 6556079
• Report Number: 2648035-2017-00842
• Device Sequence Number: 13725298
• Product Code: HQL
• UDI-Device Identifier: 05050474558113
• UDI-Public: (01)05050474558113(17)190708
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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: 07/08/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1