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 Code	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 10.5 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017.It was later explanted due to unknown reasons and replaced with model zcb00.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received reported that the reason for explant was because the patient was unhappy with the lens.Also, the explant date was (b)(6) 2017, and the replacement lens was a model zcb00, 10.5 diopter.Reportedly, there was no patient injury and no vitrectomy was performed.No additional information was provided.If explanted, give date: (b)(6) 2017.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the labeling was not reviewed because limited information was received.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 7012478
• Report Number: 9614546-2017-01079
• Device Sequence Number: 1677215
• Product Code: POE
• UDI-Device Identifier: 05050474591653
• UDI-Public: (01)05050474591653(17)220517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/21/2018

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: 05/17/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 02/06/2018; 02/26/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 03/06/2018; 03/21/2018
• 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