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	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxr00 31.5 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2017, because the patient complained of severe glare.In addition, the patient complained of colors not being seen as their true colors.The patient reported black looks like dark purple, gray looks purple, purple looks vibrant purple, and blue looks like periwinkle.There was no incision enlargement or vitrectomy performed.The replacement lens was a zcb00 30.5 diopter iol.Reportedly, there was no patient injury, the surgery went okay, and the patient is doing well.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for evaluation.The reported complaint cannot be verified.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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 92705
• MDR Report Key: 7015401
• Report Number: 9614546-2017-01080
• Device Sequence Number: 1745039
• Product Code: POE
• UDI-Device Identifier: 05050474591820
• UDI-Public: (01)05050474591820(17)211017
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/17/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 01/18/2018
• 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