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

Model Number	ZXR00
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	10/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown/not provided.Exact date when patient experienced blurry vision was not provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after implantation of a zxr00 intraocular lens (iol), a patient complained about blurry vision on all four post-ops.The iol was explanted.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up it was learned the patient had complained of the blurry vision on next day, 1 week, 2 weeks and 1 month post-op visits.It was also learned that the zxr00 lens was explanted from a female patient's left eye and replaced with the same model lens with a 30.0 diopter.There was no incision enlargement, vitrectomy, sutures required.Furthermore, the initial report indicated that the explant occurred on (b)(6) 2016, however it was learned that this was actually the implant date and the explant occurred on (b)(6) 2016.Age/date of birth: (b)(6) 1952.Gender/sex: female.On (b)(6) 2016 - as a result of the follow up it was learned the blurry vision was noted initially the next day post-op.If implanted, give date: (b)(6) 2016.If explanted, give date: (b)(6) 2016.Additional reporter: dr.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.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 intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6197516
• Report Number: 9614546-2016-00705
• Device Sequence Number: 10918405
• Product Code: POE
• UDI-Device Identifier: 05050474591820
• UDI-Public: (01)05050474591820(17)210818
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2017

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: 08/18/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 01/18/2017; 04/24/2017
• 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
• Patient Age: 63 YR