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	09/13/2017
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 25.0 diopter intraocular lens (iol) was implanted into the left eye (os) of the patient on (b)(6) 2017.It was later explanted on (b)(6) 2017, due to going from a multifocal to a non multifocal lens.There was no incision enlargement, vitrectomy or capsule tear.The lens was replaced with a zcb00 with a lower diopter iol.Reportedly, there was no patient injury and the patient is doing well post-operatively.No further information was provide.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 1/5/2018 device returned to manufacturer? yes.Device evaluation: the product was received in a lens case.The product was inspected by a qualified inspector using a 12x magnification.It can be seen that the product was cut, most probably to make explant possible.Investigation of the return sample and the condition does not suggest the damage was introduced during manufacturing.The customer''s reported event could not be confirmed.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 was received regarding the issue.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 7089530
• Report Number: 9614546-2017-01205
• Device Sequence Number: 1798326
• Product Code: POE
• UDI-Device Identifier: 05050474579194
• UDI-Public: (01)05050474579194(17)220721
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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: 07/21/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/08/2018
• 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: 65 YR