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

Model Number	ZXR00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an intraocular lens (iol) was inserted into the patient's eye and it looked like it was cracked.Reportedly, the lens was removed.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 09/14/2017.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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 were 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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6847549
• Report Number: 9614546-2017-00844
• Device Sequence Number: 19190160
• Product Code: POE
• UDI-Device Identifier: 05050474579033
• UDI-Public: (01)05050474579033(17)220719
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/16/2017

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: 07/19/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE 1MTEC30, LOT CC07043