MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A zkb00 intraocular lens was explanted from the right eye of a patient.The reason for the explant is unknown.The incision was enlarged.No sutures were required.There was no patient injury.Another lens of the same model but a higher diopter was implanted.No additional information has been provided.
Additional Manufacturer Narrative
Device available for evaluation - yes.Returned to manufacturer on: 09/19/2016.Device returned to manufacturer - yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection revealed that the lens was cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis was not possible.The customer's reported complaint could not be verified.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.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5904786
• Report Number: 9614546-2016-00418
• Device Sequence Number: 25843
• Product Code: MFK
• UDI-Device Identifier: 05050474560031
• UDI-Public: (01)05050474560031(17)200209
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2016

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: 02/09/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2016
• Supplement Report FDA Received Date: 11/22/2016
• 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
• Patient Age: 67 YR