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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant dates ((b)(6) 2016) were provided for the lenses implanted in the patient's two eyes however without serial number association.There is no indication at the time of this report that the lens has been explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Initially, it was reported that a female patient experienced severe starburst at night ((b)(6) 2016) while driving, sharp pain in eye and sensation of debris in eye after implantation of an abbott product for 1 month.During a follow up, customer provided serial numbers (b)(4) implanted in patient's eyes.Reportedly, right eye lens was implanted on (b)(6) 2016 and left eye lens was implanted on (b)(6) 2016.No further information was provided.This report represents the lens serial number (b)(4).A separate report is being filed for the lens serial number (b)(4).
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned; therefore, an investigation was not possible.The customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The product was manufactured according to specification.A search of complaints revealed that no similar complaints were received for this production order number.Labeling evaluation: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.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: 6207945
• Report Number: 9614546-2016-00720
• Device Sequence Number: 13669610
• Product Code: MFK
• UDI-Device Identifier: 05050474535718
• UDI-Public: (01)05050474535718(17)181028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2017

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: 10/28/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 03/07/2017
• 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
• Patient Age: 62 YR