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

Model Number	ZXT225
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt225 21.5 diopter intraocular lens (iol) was out of its proper position within the jewel casing and had a scratch on it when it was checked under the microscope.This occurred during handling and prior to insertion with no patient contact.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 2/16/2018.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection was perfumed using the 12x magnification shows that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.No scratch was observed on the lens.The complaint cannot be verified.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.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: 7287737
• Report Number: 9614546-2018-00170
• Device Sequence Number: 1824021
• Product Code: POE
• UDI-Device Identifier: 05050474605824
• UDI-Public: (01)05050474605824(17)210807
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/26/2018

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: 08/07/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 04/14/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1