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

Model Number	ZXT375
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown, not provided, but the best estimate date (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt375 10.0 diopter intraocular lens (iol) was implanted in the right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2017, because the lens rotated from 95 degrees to 81 degrees from the patient's one day post-operative doctor's visit to their one month follow up visit.Also, the patient complained of blurry vision, difficulty reading, and interference with daily activities.In addition, the doctor states the patient's eye anatomy was an attribute to the product issue (axial length 26.98).There was no post-operative patient injury.The lens was replaced with the same model, but different diopter of 10.5 because they did not have the original 10.0 diopter in stock.The 10.5d zxt375 was placed at 99° with a capsular tension ring.On post op day #1 lens was at 99°, ucva (uncorrected visual acuity) was 20/32- with 2+ cells and non-clinically significant corneal punctate defects.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to 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 on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 92705
• MDR Report Key: 6973807
• Report Number: 9614546-2017-01025
• Device Sequence Number: 10884733
• Product Code: POE
• UDI-Device Identifier: 05050474606777
• UDI-Public: (01)05050474606777(17)220509
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/17/2017

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: 05/09/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/17/2017
• 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: 67 YR