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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: na (not applicable) lens was removed/replaced during the same procedure.If explanted; give date: na (not applicable) lens was removed/replaced during the same procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was removed and replaced during the initial procedure.During phaco, the capsule broke.This affected the patent's left eye.The implanted symphony lens was not to blame.The lens was inserted, the incision enlarged, vitrectomy performed, and sutures were used.There was no post-op patient injury reported.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 03/08/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was damaged, most probably to make the explant possible.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6295407
• Report Number: 9614546-2017-00063
• Device Sequence Number: 1056457
• Product Code: POE
• UDI-Device Identifier: 05050474605770
• UDI-Public: (01)05050474605770(17)211026
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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: 10/26/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U190
• 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: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 05/12/2017
• 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: 70 YR