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

Model Number	ZXT225
Medical Device Problem Codes	Premature Activation (1484); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted; give date: not applicable as the lens was inserted and removed.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during the insertion of an intraocular lens (iol) into the patient's eye, the lens shot out the side of the cartridge.Reportedly, there was a slight patient contact.The device was discarded by the customer.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was discarded by the customer and could not be investigated.The reported complaint was not verified.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 directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 6593207
• Report Number: 9614546-2017-00473
• Device Sequence Number: 867247
• Product Code: POE
• UDI-Device Identifier: 05050474605794
• UDI-Public: (01)05050474605794(17)211018
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/18/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1