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

Model Number	ZCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted in a secondary surgical procedure because of a defect.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation was incorrectly populated as yes.Device returned to manufacturer was incorrectly populated as yes.Device available for evaluation: indication of yes is now appropriate for this follow up report.Returned to manufacturer on: 06/06/2017.Device returned to manufacturer yes is now appropriate for this follow up report.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the lens was received cut in two pieces and with a chipped edge.This condition could be related to the explant process.As the customer did not report a specific defect observed on the lens, the complaint could be identified.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) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.As a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics 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: 6585672
• Report Number: 2648035-2017-00931
• Device Sequence Number: 395435
• Product Code: HQL
• UDI-Device Identifier: 05050474531536
• UDI-Public: (01)05050474531536(17)200304
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 06/28/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/04/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 06/29/2017
• 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