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

Model Number	ZXR00
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	Corneal Edema (1791); Pain (1994); Blurred Vision (2137)
Date of Event	12/13/2017
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 13.0 diopter intraocular lens (iol) was implanted in the patient's operative eye.The iol was found to be cracked during post operative examination.It was later explanted due to patient complaining of blurriness.Patient also complained of pain.During the explant incision enlargement was performed.There was no vitrectomy performed and there was no capsular bag tear.A non-amo iol was used as the replacement lens for the patient.Further details were provided and reported that during one day post examination patient complained about blurry vision and was not happy with the lens.Doctor added that during implantation on (b)(6) 2017, optic appeared to be fractured after implantation.As the lens was in the eye, the doctor decided to keep it in as it appeared to be fine to him after implantation.But patient came back the next day and complained about blurry vision so he decided to explant.Contributing medical history noted as pupil dilation.Corneal edema after explant but he is recovering and is getting better.No additional information was provided.
Additional Manufacturer Narrative
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 the specifications.A search revealed that no similar complaints were received from 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
• MDR Report Key: 7207948
• Report Number: 9614546-2018-00080
• Device Sequence Number: 10943462
• Product Code: POE
• UDI-Device Identifier: 05050474591707
• UDI-Public: (01)05050474591707(17)220915
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/15/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 04/12/2018
• 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
• Patient Age: 78 YR