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

Model Number	ZXR00
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported a zxr00 9.5 diopter intraocular lens (iol) was explanted due to a unspecified lens malfunction.The lens was replaced with the same model zxr00, but lower diopter of 8.0.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 08/24/2017.Device returned to manufacturer? yes.Device evaluation: visual inspection with the unaided eye shows the product was cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the labeling was not reviewed because limited information on the product issue was received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics 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: 6826248
• Report Number: 9614546-2017-00812
• Device Sequence Number: 1118160
• Product Code: POE
• UDI-Device Identifier: 05050474591639
• UDI-Public: (01)05050474591639(17)210907
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/07/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/19/2017
• 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