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

Model Number	ZXT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/10/2017
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 toric intraocular lens (iol) was implanted without complications, in the left eye of a male patient.Six weeks post operation, it was noted that the lens was dislocated.Reportedly, the lens was repositioned in a secondary surgical procedure on (b)(6) 2017.The lens was reported being perfectly centered.The patient tolerated the procedure well, and was returned to the recovery room in good condition.Additional information was received and it was learnt that the problem first occurred on (b)(6) 2017; the day the lens was implanted.The lens kept falling off the capsular bag, the iol continued to move and had moved twice and on the third time the lens was explanted and replaced.The lens was explanted on (b)(6) 2017.There was no incision enlargement, no vitrectomy was performed and no patient injury was reported.The patient was reported doing well.The lens was replaced with a different lens model, z9002, and smaller dioptre, +16.0.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and 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: 6514045
• Report Number: 9614546-2017-00315
• Device Sequence Number: 16167461
• Product Code: POE
• UDI-Device Identifier: 05050474605152
• UDI-Public: (01)05050474605152(17)211102
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/02/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2017
• Supplement Report FDA Received Date: 06/12/2017
• 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: 59 YR