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)
Date of Event	12/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxr00 16.5 diopter was explanted due to unexpected postop refraction outcome.Before the surgery a 17.5 diopter lens was selected but the ora (ocular response analyzer) suggested a 16.5 size lens.The physcian noted that even the 17.5 would not have been enough power because on day 1 the patient was about +2 and then at 6 days the patient was somewhere between + 1.25 and 1.5 spherical equivalent (se).The patient's distance was okay but the near was poor.There were no complications reported with the lens exchange and the surgeon does not feel the lens is implicated in the refractive miss.Day 1, after the lens exchange, patient was 20/25 and j5.Patient was much happier but still fairly dilated.The physcian noted that the patient wants her 2nd eye done next week, however the surgeon plans to have the patient wait a bit for second eye.
Additional Manufacturer Narrative
Additional information: it was learned that the lens was explanted from a (b)(6) year old female patient's left eye.The lens was replaced with the same model lens but with a larger diopter.There was no incision enlargement, vitrectomy, or sutures required.There was no complications or injury reported.Age/date of birth: (b)(6).Gender/sex: female.Device available for evaluation ¿ yes, returned to manufacturer on 03/08/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The reported complaint could not be confirmed in the returned sample.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: 6291696
• Report Number: 9614546-2017-00060
• Device Sequence Number: 810651
• Product Code: POE
• UDI-Device Identifier: 05050474579026
• UDI-Public: (01)05050474579026(17)211012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: 10/12/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 05/03/2017
• 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: 69 YR