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

Model Number	ZLB00
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
Gender/sex: unknown/not provided.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that the a zlb00 25.0 diopter intraocular lens was explanted due to patient having hyperopia.Additionally, patient was having trouble accommodating to the lens.The lens was exchanged and there was no incision enlargement, no vitrectomy and no sutures required.There was no patient injury reported.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation?yes, returned to manufacturer on 5/29/2017.Device returned to manufacturer?yes.Device evaluation: the device was returned to the manufacturer.Visual inspection that was performed by a qualified inspector using 12x magnification shows that the product is damaged, most probably to make explant possible.Considering the condition of the lens additional applicable analysis is not possible.The reported issue could not be confirmed in the returned sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were 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.
Additional Manufacturer Narrative
Corrected data: in mdr follow up #1, additional coding for results and conclusion were inadvertently not included.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: 6593278
• Report Number: 9614546-2017-00476
• Device Sequence Number: 19027954
• Product Code: MFK
• UDI-Device Identifier: 05050474560772
• UDI-Public: (01)05050474560772(17)190401
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2017

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: 04/01/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 07/06/2017; 07/31/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/31/2017; 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: Required Intervention