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	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.If implanted, give date: unknown/not provided - unknown if lens was fully implanted, reported as removed.If explanted, give date: unknown/not provided - lens reported as removed based on the limited information unable to confirm if the lens was explanted in a secondary procedure or removed during the initial implant procedure.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a capsule tear occurred and a zcb00 12.5 diopter intraocular lens (iol) was removed from the eye.The customer thinks the product was discarded and therefore not available for return.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: 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 additional investigations requests for this po 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.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 06/29/2017.Device returned to manufacturer ¿ yes.Visual inspection at 10x microscope magnification was performed: a piece of lens returned for evaluation.Fibers/particles were observed on lens piece related to the handling of the unit out of a sterile environment.Residues of viscoelastic solution were also observed which indicate that the unit was handled and prepare for surgical use.The complaint issue reported could not be verified.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: 6558902
• Report Number: 2648035-2017-00847
• Device Sequence Number: 687176
• Product Code: HQL
• UDI-Device Identifier: 05050474531567
• UDI-Public: (01)05050474531567(17)200312
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 07/31/2017

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: 03/12/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided; 07/06/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 06/05/2017; 08/01/2017
• 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: Other