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	Visual Impairment (2138); No Code Available (3191)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable.To date there is no indication that the lens has been explanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
Reportedly, a physician complained a case in which a toric iol was implanted and essentially provided no astigmatism correction.The zxt375 10.5 diopter intraocular lens was implanted in a female patient's left eye on (b)(6)2017.Patient's vision was on 2100.However, on (b)(6)17 patient's visual acuity was 20/70, lens was rotated on (b)(6)2017.Post rotation, patient's visual acuity as 20/60.And on (b)(6)2017 the patient's visual acuity for distance was 20/40, intermediate: 20/50, and near 20/80.The refraction was plano + 125 at 10.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site as it remains implanted.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
• MDR Report Key: 6843722
• Report Number: 9614546-2017-00837
• Device Sequence Number: 699659
• Product Code: MFK
• UDI-Device Identifier: 05050474606784
• UDI-Public: (01)05050474606784(17)220522
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2017

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: 05/22/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/21/2017
• 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: 68 YR