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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.If implanted, give date: not applicable as the lens was inserted and removed.If explanted, give date: not applicable as the lens was inserted and removed.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that during implantation of zxt150 19.5 diopter intraocular lens, the patient moved and the lens had to be removed.The physician had to enlarge the incision to be able to implant the new lens.It was also reported that the lens will not be available for evaluation as the lens was thrown away by the surgical technician.
Additional Manufacturer Narrative
Device evaluation: the product was discarded by the customer.Therefore, a product investigation could not be performed.The customer's reported complaint could not be 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 additional similar complaints for this order number have been received.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.
Additional Manufacturer Narrative
As a result of follow up the physician's contact information was obtained and has been entered into section as an additional complaint reporter.No additional information was provided to abbott medical optics.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6421388
• Report Number: 9614546-2017-00216
• Device Sequence Number: 853026
• Product Code: POE
• UDI-Device Identifier: 05050474605190
• UDI-Public: (01)05050474605190(17)211214
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/14/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/19/2017; 06/22/2017
• 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: Other