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) 2018.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxr00 11.0 diopter intraocular lens (iol) was implanted in the patient's left eye (os) on (b)(6) 2018.It was later explanted on (b)(6) 2018 due to the patient experiencing visual disturbance, which did not significantly interfere with activities of daily life.There was no incision enlargement and the patient has recovered.The replacement lens was a zma00 10.5 diopter lens.No additional information was provided.
Additional Manufacturer Narrative
Per follow-up, customer stated that she can't confirm if the lens was returned.She will look through her records and call back if she finds any information on the disposition of the lens.No additional information provided.The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.The manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.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: 7301816
• Report Number: 9614546-2018-00201
• Device Sequence Number: 19171127
• Product Code: POE
• UDI-Device Identifier: 05050474591660
• UDI-Public: (01)05050474591660(17)220125
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018
• Report Date (Section F): 01/01/2005

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: 01/25/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 07/06/2018
• 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
• Date Report Sent to FDA: 01/01/2005