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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported a zcb00 26.0 diopter intraocular lens (iol) was explanted due to a refractive surprise and for the patient requiring a diopter change.There was no incision enlargement, no vitrectomy and no sutures required.Additionally, there was no patient post-op injury reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 5/05/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Device inspection was performed and the lens is cut in two pieces.The reported issue was not verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaints have been received for this production order number.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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6515062
• Report Number: 2648035-2017-00726
• Device Sequence Number: 1268599
• Product Code: HQL
• UDI-Device Identifier: 05050474531833
• UDI-Public: (01)05050474531833(17)200828
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 08/28/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2017
• Supplement Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention