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

Model Number	ZXT150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.Concomitant medical products: additional concomitant product - 1mtec30 cartridge lot# cb39356 all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during the implantation of a toric intraocular lens (iol) it was very difficult and tight to advance the lens in the cartridge.The surgeon was able to deliver the lens into the patient's eye with a lot of force and using a second instrument.The surgeon noticed that the tip of the plunger nicked the edge of the iol but believes the patient will be ok and the vision will not be compromised.There is not plan on exchanging the lens.No further information was provided.Two mdrs will be filed.One for the cartridge and one for the lens (this report).
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at 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 revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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: 6188117
• Report Number: 9614546-2016-00696
• Device Sequence Number: 52889
• Product Code: POE
• UDI-Device Identifier: 05050474605084
• UDI-Public: (01)05050474605084(17)210811
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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: 08/11/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1