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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	05/15/2017
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 a tecnis multifocal intraocular lens (iol), model zma00 7.5 diopters, was implanted on (b)(6) 2016.The patient returned on (b)(6) 2017 to reposition the lens due to blurry vision.The doctor reported that he feels he damaged the lens by scratching it during the repositioning procedure.Therefore, the patient returned (b)(6) 2017 to have the lens explanted and had another lens of the same lens model and diopter implanted.Patient is doing fine.There was no incision enlargement or vitrectomy during the explant.The product will not be returned.No additional information was provided.
Additional Manufacturer Narrative
In the initial mdr submitted were not populated as required.The following sections have been updated accordingly.Adverse event and/or product problem: adverse event.Outcomes attributed to adverse event: required intervention.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site.Therefore, product testing could not be performed and 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 on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6812175
• Report Number: 9614546-2017-00786
• Device Sequence Number: 13701081
• Product Code: MFK
• UDI-Device Identifier: 05050474536555
• UDI-Public: (01)05050474536555(17)210916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2017

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: 09/16/2021
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/11/2017; 09/18/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 09/05/2017; 10/11/2017
• 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